Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614209

FEI Number

3002806725

Entity Name

Corin Limited

City/State/Country

CIRENCESTER Gloucestershire, GB

Establishment Address

THE CORINIUM CENTRE, CIRENCESTER Gloucestershire GL7 1YJ, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Corin Group (Owner Number: 9012268)

Owner / Operator Contact Address

THE CORINIUM CENTRE, --, CIRENCESTER, GB-GLS GL7 1YJ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121439

PMA Number

N/A

All Registered Proprietary Names

Bipolar-i Thompson Hip (Cobalt Chrome) Cenator Total Hip System Oxford Modular Shoulder Posterior Stabilised NTK System C-Fit Stem (VSP & Plasma Coated) HLS KNEETEC Corin Taper-Fit Total Hip System Paragon Hip Stem NS-5034B TKR.IN.1332 TKR.BB.1102 KS-62030 TKR.OB.1300 NS-5055B Apollo Knee TKR.BB.1701 NS-5031A TKR.BB.1702 TKR.IN.1400 TKR.BB.1401 COR.TS.1500 NS-5036B NS-40300 TKR.IN001 TKR.IN02U NS-300F4 TKR.IN.1352 TKR.IN.1700 4148-1004 NS-5056A TKR.BB.1704 NS-5032A TKR.BB.1700 TKR.IN.1600 NS-5054A TKR.IN.1800 NS-300T4 TKR.BB.1706 TKR.KT.1300 4145-5003 NS-5058B 4145-5004 TKR.BB.1400 NS-5053A TKR.BB.1403 NS-5032B 4148-1002 TKR.BB.1101 TKR.IN.1341 NS-5034A COR.TS.1900 NS-300G4 TKR.BB.1402 NS-5053B NS-5057B COR.TS.1600 TKR.IN02A 4148-1005 4154-5000 NS-5036A TKR.BB.1103 TKR.IN003 TKR.BB.1200 NS-5033B NS-300P4 NS-5031B NS-5035B NS-40150 NS-5035A NS-40130 NS-5033A TKR.BB.1703 4137-2050 4148-1001 NS-5054B TKR.BB.1707 NS-5055A TKR.BB.1100 COR.TS.1700 4137-5050 COR.TS.1800 NS-5058A TKR.IN.1342 TKR.BB.1500 COR.TS.1300 NS-5056B TKR.IN.1351 4145-1030 TKR.OB.1200 4149-5000 TKR.OB.1400 TKR.IN.1331 NS-5057A TKR.OB.1201 4144-8000 NS-40100 TKR.BB.1705 DAY STAPLE CORMET HIP RESURFACING SYSTEM Trinity Acetabular System with XS Heads HLS NOETOS HLS Uni Evolution Nuffield Total Knee Unity Total Knee System Corifix Ligament Anchor Screw MULTILOK HAND TABLE Trinity Acetabular System with No Hole Shells Corin Metafix Hip Stem TaperFit Hip Stem Trinity-i Acetabular Shells Cormet Cementless Hemi Head HLS NOETOS revision ENDOCAM DAYCAM ENDOSCOPIC VIDEO CAMERA Surgical Instrument Trinity Acetabular System with No TPS Shells Cormet HemiHip Metallic Resurfacing Modular Moore Stem Corifix Dynamic Hip Screw Rotaglide+ Modular Knee System DC-FIT ACETABULR CUP SYSTEM THE C-FIT C-Fit Total Hip TriFit CF MiniHip Size 3 ApolloHipX UNIGLIDE UNICONDYLAR Unity Total Knee CS Insert Trifix Pedicle Spinal Screw Assembl Unity Total Knee System Sterile Tablet Cover Icona Hip Stem Trinity Polyaxial Screw, 6mm Rod Taper-Fit Total Hip System Kaiser Medical Technology Solomax GenesisTech Pulse Irrigation System Tri-Fit Femoral Hip System Trinity EVO Acetabular Shell Trinity PLUS Acetabular Shell Zyranox Zirconia Ceramic Femoral MiniHip Stem 1120616 1120868 1120818 1120509 1120770 1120220 1120810 1120320 1120518 1120861 1120411 1120862 1120711 1120512 1120222 1120811 1120416 1120716 1120618 1120318 1120910 1120762 1120768 1120712 1120816 1120612 1120112 1120514 1120909 1120809 1120422 1120766 1120814 1120109 1120772 1120510 1120914 1120110 1120214 1120409 1120511 1120714 1120922 1120314 1120412 1120316 1120410 1120918 1120920 1120114 1120111 1120722 1120210 1120759 1120860 1120420 1120720 1120322 1120118 1120864 1120709 1120209 1120122 1120312 1120710 1120218 1120872 1120911 1120761 1120310 1120916 1120620 1120822 1120216 1233702 1120609 1120614 1120311 1120309 1120120 1120760 1120820 1120912 1120516 1120611 1120870 1120520 1120812 1120211 1233701 1120116 1120718 1120866 1120764 1120859 1120622 1120610 1120414 1120418 1120212 1233703 1120522 1233791 UNITY KNEE MC INSERT ENDOBEAM XENON ENDO KNEETEC PFJ MetaFix Hip Stem Trinity with MiniHip & Metafix Stems Trinity Acetabular System C-Fit/DC-Fit Acetabular Cup System Unity Total Knee System Corin Bipolar (Cobalt Chrome) Trinity Acetabular Hip System with HXLPE Liners Trinity Acetabular System with XL Heads Rod to Rod Spinal Cross Brace Freeman Cup Plasma Coated NTK System C-Fit Femoral Hip System Metafix Femoral Hip Stem size 1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2019-06-24
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2007-12-18
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-12-18
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2007-12-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2007-12-18
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-12-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-03-09
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	Orthopedic	Class 2	888.3360	2007-12-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-12-17
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-12-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-03-04
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2006-01-30
NXT	Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing	Unknown	Class 3	N/A	2007-07-16
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-10-23
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-10-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-03-09
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2017-03-09
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2007-12-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-09-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-12-18
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2004-03-02
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-03-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-03-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2010-02-17
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2010-02-17
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2015-04-07
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	Orthopedic	Class 2	888.3360	2015-04-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-11-27
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2012-11-27
KXA	Prosthesis, Hip, Femoral, Resurfacing	Orthopedic	Class 2	888.3400	2013-09-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-03-09
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2006-01-30
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-08-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-02-14
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-02-14
KXA	Prosthesis, Hip, Femoral, Resurfacing	Orthopedic	Class 2	888.3400	2007-12-18
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2007-12-18
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2007-12-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2007-12-18
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	Class 1	864.2220	1998-01-29
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-12-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-05-02
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2018-05-02
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2018-05-02
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2018-05-02
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2018-05-02
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-05-02
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-07-08
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-01-28
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2005-09-19
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-06-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2007-12-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2007-12-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2007-12-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-02-27
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2026-01-29
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-11-11
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-11-11
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2024-11-11
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-11-11
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2007-12-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2007-12-18
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-12-18
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2010-04-30
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2007-12-18
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2007-12-18
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2025-06-09
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-06-09
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2025-06-09
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-06-09
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2025-06-09
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-07-27
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2018-07-27
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2018-07-27
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-07-27
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2018-07-27
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2007-12-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2010-04-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-07-03
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-09-27
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2024-09-27
GCT	Light Source, Endoscope, Xenon Arc	Gastroenterology, Urology	Class 2	876.1500	2006-02-02
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2017-03-09
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2022-04-12
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2022-04-12
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2022-04-12
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2022-04-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-04-12
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-04-12
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2011-03-14
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-03-14
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2011-03-14
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2010-12-23
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2010-12-23
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2010-12-23
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-12-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-09-17
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2007-12-18
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2011-05-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-05-06
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-06-04
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-06-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2007-12-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2007-12-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2007-12-18
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2007-12-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2007-12-18
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-12-18
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2012-09-17
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-09-17
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2012-09-17

Official Correspondent

Aaron Brunt

US Agent Details

Lucinda Gerber Email: lucinda.gerber@coringroup.com Phone: (772) 3212478

Related Public Records

Same Entity

Corin Group

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013682146	OMNIlife science, Inc.	Milpitas, CA, US
1226188	OMNIlifeScience, Inc.	Raynham, MA, US
3012916784	OPTIMIZED ORTHO PTY LTD	Sydney New South Wales, AU

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K823482	Intermedics Orthopedics	101 UNIVERSAL ENDOPROSTHESIS	1983-02-07
K940328	Orthopaedic Innovations, Inc.	PRIME CEMENTED HIP SYSTEM	1995-04-07
K950761	Biomet, Inc.	INDEX ACETABULAT COMPONENT	1995-05-02
K972928	Howmedica, Inc.	KERBOULL CROSS	1997-11-03
K830313	Biomet, Inc.	CFE TOTAL HIP FEMORAL COMPONENT	1983-05-25

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 9614209. Last updated year: 2026. Please use registration number 9614209 when referencing this establishment in official correspondence.