Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009882462

FEI Number

3009882462

Entity Name

PERRYMAN COMPANY

City/State/Country

Houston, PA, US

Establishment Address

149 S Johnson Rd, Houston, PA 15342, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Perryman Company (Owner Number: 10042198)

Owner / Operator Contact Address

149 South Johnson Rd, Houston, PA 15342, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

S&N R3 XLPE ACETABULAR LINER (D464976) ART - iBalance® TKA Tibial Bearing Implant, CR- CR TIBIAL BEARING, VIT E (C11614-XXX), Device Listing: D318888 ART - iBalance® TKA Tibial Bearing Implant, PS, PS TIBIAL BEARING (C4970-XXX), Device Listing: D318888 ART- iBalance® Patella Implant Dome, DOME PATELLA COMP (C4968-0X), Device Listing: D318888 ART - iBalance® TKA Tib Bearing Implant, CR Plus, Vit E, CR PLUS TIB BEARING, VIT E (C11617-XX) Device Listing: D318888 ART - iBalance® TKA Tibial Bearing Implant, CR Plus, CR PLUS TIBIAL BEARING (C9732-XX), Device Listing: D318888 ART - iBalance® TKA Tibial Bearing Implant, CR Plus, CR PLUS TIBIAL BEARING (C6547-XX), Device Listing: D318888 DPY - EMPHASYS Forgings (Core Sizes), Device Listing: D481212 Attune Revision JOURNEY II Uni Tibial Base and Insert Klassic Tibial Insert, PS-Max, Std Poly Endoskeleton TA IBD NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS Legend Legend Acetabular Liner (D323120) ART - Arthrex Eclipse Trial Head (AR-94XX-XX), Device Listing: D354030 Globus - ONVOY Acetabular Shells (P/N 1235.XXXX), Device Listing D487212 MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST) Globus - GENFlex2 / Proven Gen-Flex (2196-X-XX) Femoral & Tibial Stems, Device Listing# D510408 BKS TriMax GLENOSPHERE TRIAL (36mm & 40mm) GLENOSPHERE TRIAL EXPANDED (36mm & 40mm) ART - iBalance® HTO Trial (SP-13400-XX), Device Listing: D096099 LEGION Knee System OR3O Omni-tract NATURAL-KNEE II CONSTRAINED KNEE SYSTEM TJO - TIBIAL INSERT SET SCREW (5603000), Device Listing: D178113 TJO - Tibial Insert, Ultra-PS, Std Poly, (5301X.XXX), Device Listing: D178113 TJO - Tibial Insert, CR/Congruent, Std Poly (5300.XX.XXX), Device Listing: D178113 TJO - Domed Patella, (5500.XX.XXX), Device Listing: D178113 TJO - TIBIAL BASEPLATE, NONPOROUS (5201.XX.XXX), Device Listing: D178113 TJO - Dome Extension (5601000), Device Listing: D178113 TJO - Tibial Insert, Ultra-PS, Std Poly (5301.XX.XXX), Device Listing: D178113 TJO - Tibial Insert Set Screw (5602000), Device Listing: D178113 REDAPT GENESIS II Bumper LEGION LEGION Stem Omni-tract POSTERIOR STABILIZED APOLLO KNEE SYSTEM TJO - Klassic Stem Extension, Femoral, Cemented, (6600.XX00), Device Listing: D504229 Acetabular Insert Trial Balanced Knee System Ultracongruent Tibial Insert Triathlon iBalance TKA System - CR Plus Tibial Bearing NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW ANATOMICAL SHOULDER TM COMBINED SYSTEM JOURNEY II XR Knee System NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM REDAPT LEGION Knee System Endoskeleton TCS® iBalance TKA System - CR Plus Tibial Bearing JOURNEY JOURNEY II CR Knee System EXT - Vantage®, ActivitE, Fixed Bearing Ankle Liner, Device Listing: D524182 Aequalis PerForm+ Reversed RTSA BASEPLATE DRILL GUIDE DPY - PINNACLE, PINNACLE TRIAL LINERS, Device Listing: Q019772 DPY - GLOBAL ADVANTAGE, GLOBAL ADVANTAGE HEAD TRIAL (2128650X0), Device Listing: Q019772 DPY - P.F.C., DOME PATELLA TRIAL (86613X), Device Listing: Q019772 DPY - GLOBAL ANCHOR PEG GLENOID, ANCHOR PEG GLENOID TRIAL (2236800X0), Device Listing: Q019772 DPY - GLOBAL UNITE, GLOBAL UNITE CELCON GD (210061071), Device Listing: Q019772 DPY - ATTUNE KNEE SYSTEM,EN - ATTUNE, REVISION FB INSERT TRIAL, (25170XXXX). Device Listing: Q019772 PEG GLENOID TRIAL (SMALL, MEDIUM, LARGE, XLARGE) ART - iBalance UKA®, Tibial Bearing Trial, UNI-KNEE TIBIAL BEARING (AR-601-TBXX), Device Listing: D223058 GLENOSPHERE TRIAL (38mm & 42mm) PERFORM Humeral System Tornier Perform Humeral System DPY - PINNACLE, PINNACLE MB HEAD TRIALS (22172XXXX), Device Listing: Q019772 EXP HEAD TRIAL (47MM, 50MM, 53MM) FULL AUGMENT SIZERS / FULL AUGMENT TRIALS EXT HEAD TRIAL (XSHORT, SHORT, TALL) Equinoxe - EXT B047065 LEGION (LGN STD CR INSERT TRIALS, 8111411X) Device Listing R060915 ART - iBalance UKA®, Tibial D-Ring Trial, TRIAL BASE PLATE, (AR-611-3X), Device Listing, D223058 DPY - EMPHASYS, EMSYS DM Trial Liner (4825XXXXX), Device Listing: Q019772 DPY - DPS TRIAL HEADS (4831XXXXX), Device Listing: Q019772 DPY - EMPHASYS, EMSYS MB Head Trial (4830XXXXX), Device Listing: Q019772 DPY - GLOBAL APG+, APG+ Trial (2236000XX), Device Listing: Q019772 DPY - EMPHASYS, EMSYS Trial Liners (4821XXXXX), Device Listing: Q019772 LEGION (PS INSERT TRIALS, 8111XXXX) Device Listing R060915 DPY - ATTUNE®, ATTUNE BAL BLK POSITIONER (25450551X) Device Listing: Q019772 DPY - PINNACLE & PINNACLE BANTEM, EN,- BANTAM PINNACLE TRIAL LINERS (221822_28XXX), Device Listing: Q019772 DPY - PINNACLE,EN, ALTERNATE BEARING TRIAL LINER (2218891XX), Device Listing: Q019772 DPY - PINNACLE, EN - REVISION PINNACLE TRIAL LINER (221836XXX), Device Listing: Q019772 ART - Univers Revers Trial Humeral Insert, TRIAL HUMERAL INSERT, (AR-9530XS-0X(c)) Device Listing: D223058 DPY - ATTUNE KNEE SYSTEM,EN - ATTUNE, REVISION RP INSERT TRIAL, (25171XXXX). Device Listing: Q019772 DPY - SIGMA,EN, PFC SIGMA TC3 RP TIB TRIAL INS ASSEMBLY (9633XX), Device Listing: Q019772 DPY - S-ROM, S-ROM FEMORAL HEAD TRIAL (8759XX), Device Listing: (Q019772) DPY - PINNACLE, DUAL MOBILITY LINER TRIAL (221848_66XXX), Device Listing: Q019772 DPY - SIGMA,EN, PFC SIGMA RP TRIAL (973XXX), Device Listing: Q019772 DPY - ATTUNE®, ATTUNE CR MEDIAL STABILIZED TRIAL (2547XXXXX) Device Listing: Q019772 DPY - PINNACLE, EN - PINNACLE TRIAL LINERS, Device Listing: Q019772 ART - Augmented MGS Baseplate Trial, AUGMENT BASEPLATE TRIAL, (AR-9593-2XXX), Device Listing: D223058 DPY - P.F.C., PFC ULTIMA HIP SYSTEM TRIAL (85592X), Device Listing: Q019772 DPY - SKYLINE, SIZING TRIALS (410270XXX), Device Listing: D112268 Restoration S&N POROUS TIBIA BASEPLATE W/ JRNY LOCK (D452290) Klassic® BiPolar Trial, Locking Klassic® BiPolar Sizing Handle, Locking Balanced Knee® System TriMax CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts NEW ZIMMER SHOULDER SYSTEM Equinoxe Stemless Shoulder Endoskeleton TAS IBD S&N - LEGION (PS INSERTS, 811XXXXX) Device Listing D471724 MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST) Global Shoulder Steptech Anchor Peg Glenoid ART - iBalance® TKA Tibial Tray, UKA TIBIA CEMENTED TRAY (AR-511-TXX), Device Listing: D375679 Endoskeleton TO IBD Escalade Legend Acetabular Shell BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION JOURNEY Ortho Development Balanced Knee System iBalance TKA System - CR Plus Tibial Bearing DPY - GLOBAL ADVANTAGE, GLOBAL ADVANTAGE OSTEOTOMY GUIDE (212861071), Device Listing: D466363 Escalade Acetabular Cup System Escalade Machined Blanks (170-2-XXXXX) Device Listing D123552, Legion Hooded Acetabular Insert Trial, 36mm ID, 64mm Hooded Acetabular Insert Trial, 28mm ID, 44mm Hooded Acetabular Insert Trial, 32mm ID, 62mm Hooded Acetabular Insert Trial, 32mm ID, 58mm Hooded Acetabular Insert Trial, 36mm ID, 54mm Hooded Acetabular Insert Trial, 36mm ID, 60mm Hooded Acetabular Insert Trial, 32mm ID, 54mm Hooded Acetabular Insert Trial, 28mm ID, 46mm Hooded Acetabular Insert Trial, 32mm ID, 50mm Hooded Acetabular Insert Trial, 32mm ID, 56mm Hooded Acetabular Insert Trial, 36mm ID, 56mm Hooded Acetabular Insert Trial, 32mm ID, 48mm Hooded Acetabular Insert Trial, 32mm ID, 60mm Hooded Acetabular Insert Trial, 32mm ID, 64mm Hooded Acetabular Insert Trial, 32mm ID, 52mm Hooded Acetabular Insert Trial, 36mm ID, 62mm Hooded Acetabular Insert Trial, 36mm ID, 58mm Hooded Acetabular Insert Trial, 36mm ID, 52mm Genflex2 CR Ultracongruent Tibial Insert Klassic® All-Poly Tibia, Ultra-PS®, Std Poly Klassic® All-Poly Tibia, CR/Congruent, Std Poly

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-03-14
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2025-06-10
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2025-06-10
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-04-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-04-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2017-01-04
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-01-04
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2015-10-29
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2021-02-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-02-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-12-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-12-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-02-01
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-01-16
QHQ	Total Shoulder Arthroplasty System	Orthopedic	Class 2	888.3660	2025-06-10
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2023-01-24
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2023-01-24
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2023-01-24
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-13
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2012-12-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-05-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-11-11
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2014-11-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-04-01
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-01-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-01-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-01-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-08
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-02-15
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2018-01-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-12-13
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-03
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-03
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-11-11
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-02
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-01-15
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2013-01-08
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2013-01-08
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2013-01-08
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-08
KRQ	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3550	2013-01-08
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2013-01-08
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-01-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-01-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-08
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2018-01-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-12-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-04-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-04-26
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2024-04-26
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2017-01-04
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2017-01-04
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2017-01-04
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-12-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-01-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-11-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-02-25
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2022-02-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-12-13
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2012-12-13
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2012-12-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2012-12-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-10-29
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-01-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-01-07
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2012-12-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-02-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-08
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2018-01-15
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-01-15
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2022-02-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-02-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-08
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2024-04-26
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-28
HWT	Template	Orthopedic	Class 1	888.4800	2013-01-22
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-01-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-01-22
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2022-03-14
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2018-01-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-11-09
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2015-11-09
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2021-02-15
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-02-15
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2019-04-04
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2012-12-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-01-24
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2023-01-24
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2012-12-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-12-13
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-12-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2012-10-31
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2025-06-10
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-12-10
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2017-01-04
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2017-01-04
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2023-01-24
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2023-01-24
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2023-01-24
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2023-01-24
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2021-02-15
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-02-15
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2021-02-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-12-12
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2017-11-30
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-02-25
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2025-06-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-12-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-12-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-04-24
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2020-05-07
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2020-05-07
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2020-05-07
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2020-05-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-02-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-01-04

Official Correspondent

Dylan Crawford

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Perryman Company

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K860442	Howmedica Corp.	PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259	1986-05-06
K973124	Sulzer Orthopedics, Inc.	APR POROUS HA HIP SYSTEM	1997-11-03
K222566	Zimmer, Inc.	Zimmer Persona Personalized Knee System	2022-10-17
K252044	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Triathlon® Total Knee System - Triathlon® Gold Femoral Components	2025-10-24
K243247	Zimmer, Inc.	Persona the Personalized Knee System	2024-10-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06	Plus Orthopedics USA	2	TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009882462. Last updated year: 2026. Please use registration number 3009882462 when referencing this establishment in official correspondence.