Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1722511

FEI Number

1000143502

Entity Name

ORTHO DEVELOPMENT CORP.

City/State/Country

DRAPER, UT, US

Establishment Address

12187 SOUTH BUSINESS PARK DR., DRAPER, UT 84020, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Ortho Development Corporation (Owner Number: 9012515)

Owner / Operator Contact Address

12187 South Business Park Drive, --, Draper, UT 84020, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Balanced Knee System Porous Femoral Peg Drill Instrument Instrument Headloc Alumina and Zirconia Ceramic Heads Trivicta Legend All-Poly Cup Encompass® Cemented Hip Stem Encompass Cemented Hip System Primaloc Cementless Hip System Curette IBIS Pedical Screw System Ortho Development Balanced Knee Tibial Tray Pegged ODC B2 Bipolar Cup Balancecd Knee System Legend Acetabular Liners Instrument Headloc Zirconia Ceramic Heads Orthopedic Broach Vusion® CS Plus Vusion® TS/PS/CS Vusion® TS/PS Vusion PEEK VBR System Legend Primaloc Cemented Hip System Instrument Instrument Hemisphere Modular Cup Instrument Balanced Knee® System Balanced Knee System Ultracongruent Tibial Insert Alpine Cemented Hip System Encompass 10/12 Hip Stem TriMax Mode Trauma System Pivot Bipolar Head Vusion® OS Instrument Integrated® Spine System ISS Integrated Spine System Balanced Knee System High Flex PS BKS TriMax® Contour Spinal System Template Envision Anterior Cervical Plate System Envision® Anterior Cervical Plate System Tape, Measuring, Rulers and Calipers No brand name Instrument Tri-Plus Encompass Press-Fit Hip Stem Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella BKS E-Vitalize PS Tibial Insert, Vitamin E BKS E-Vitalize® KASM® Knee Articulating Spacer Mold Knee Articulating Spacer Molds KASM® Knee Articulating Spacer Mold Ortho Development Ceramic Femoral Heads Pisces Instrument Solitude® Unipolar Solitude Unipolar Head BKS® Revision Sleeves Instrument Instrument Encompass Press-Fit Hip Stem Ovation 10/12 Hip Stem Ovation® Hip Stem Instrument Balanced Knee System Uni Ortho Development Biolox Delta Ceramic Femoral Heads Alpine Hip Stem Alpine® Hip Stem Hemisphere Acetabular Cup Balanced Knee System Revision Offset Tibia Instrument Balanced Knee® Revision System Balanced Knee Modular Tibial System BKS Revision Headloc Ceramic Femoral Head Instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2014-09-19
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2022-01-25
HWB	Extractor	Orthopedic	Class 1	888.4540	2022-01-25
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-05-23
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-05-23
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-05-23
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2025-05-23
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-05-23
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-05-23
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-05-23
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-05-23
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2011-05-23
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-08-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-06-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-05-23
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2011-05-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-30
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-05-31
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-05-31
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-11-04
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-05-23
HTQ	Broach	Orthopedic	Class 1	888.4540	2021-08-26
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2013-06-28
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2011-05-23
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-10-14
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-10-14
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2011-05-23
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2022-11-04
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2025-12-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-12-22
LXZ	Guard, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-01-25
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-03-11
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-03-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-03-11
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2024-03-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-05-23
HXW	Bender	Orthopedic	Class 1	888.4540	2023-04-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-05-23
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2016-02-18
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2016-02-18
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2016-02-18
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2016-02-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2016-02-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2016-02-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-10-05
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2015-10-05
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-04-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-10-03
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2011-05-23
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-07-05
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2022-11-04
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2011-05-23
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2011-05-23
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2011-05-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-10-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-10-03
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2011-05-23
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2011-05-23
HWT	Template	Orthopedic	Class 1	888.4800	2021-08-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2011-05-23
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2021-08-26
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-09
HWJ	Awl	Orthopedic	Class 1	888.4540	2022-01-25
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-05-23
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2011-05-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-11-25
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2013-11-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-05-01
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2014-05-01
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-05-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-01-25
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2022-01-25
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2011-05-23
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-10-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-15
HXB	Probe	Orthopedic	Class 1	888.4540	2022-01-25
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2022-01-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-06-26
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2011-05-23
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-05-23
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-05-01
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2022-01-25
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2021-12-19
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-01-26
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2014-09-11
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2014-09-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2014-09-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-09-11
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2014-09-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-05-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-05-23
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-11-04
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-05-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-10-28
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-10-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-05-23
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2022-01-25

Official Correspondent

Drew Weaver

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ortho Development Corporation

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10
K932222	Dow Corning Wright	SLT FEMORAL HEAD	1994-05-27
K910547	Turnkey Intergration USA, Inc.	FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)	1991-04-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-04	Ortho Development Corporation	2	Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1722511. Last updated year: 2026. Please use registration number 1722511 when referencing this establishment in official correspondence.