Data / Medical devices / United States / Ortho Development Corp.
Ortho Development Corp.: FDA-registered device maker in Draper, UT, United States, 60 510(k) clearances
Ortho Development Corp. is registered with the FDA (registration 1722511) in Draper, UT, United States. It lists 54 device types. The FDA files 60 510(k) clearances under its listings, the newest dated December 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1722511
- FEI number
- 1000143502
- Address
- 12187 South Business Park DR., Draper, UT, United States, 84020
- Owner or operator
- Ortho Development Corporation (9012515)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- July 19, 1996
- Registered through
- 2026
- Brand names listed
- Alpine Cemented Hip System, Alpine Hip Stem, Alpine® Hip Stem, BKS E-Vitalize PS Tibial Insert, Vitamin E, BKS E-Vitalize®, BKS Revision, BKS Revision Cones, BKS TriMax® and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2025 | K253161 | Balanced Knee System TriMax Porous Femoral Components | MBH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| May 22, 2025 | K251052 | Trivicta® Hip Stem | MEH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| October 25, 2024 | K242984 | BKS Revision System | JWH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| October 11, 2024 | K242833 | Legend® Acetabular Shell | LPH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| March 8, 2024 | K233758 | Trivicta Hip Stem | MEH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| October 25, 2023 | K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | JWH | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| December 21, 2021 | K211086 | The Progen Trochanteric Nail System | HSB | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| December 16, 2021 | K211471 | Balanced Knee System Uni | HSX | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| July 14, 2021 | K203023 | Pisces Spinal System | NKB | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| March 31, 2020 | K200281 | The Gecko Spinal System | OWI | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| October 31, 2018 | K182085 | Balanced Knee Revision System Trabecular Tibial Cone Augments | JWH | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| October 12, 2018 | K181569 | BKS Revision Sleeves System | JWH | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| June 20, 2018 | K180743 | Balanced Knee Revision System - Offset Junction Box | JWH | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| May 30, 2018 | K173951 | Legend Acetabular Liners | LPH | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| August 24, 2017 | K171249 | Entrada hip stem | MEH | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| March 30, 2017 | K162995 | Ibis® Pedicle Screw System | NKB | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| May 17, 2016 | K161080 | Escalade Legend Acetabular Shell | LPH | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| February 18, 2016 | K153216 | Alpine Cemented Hip System | JDI | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| October 27, 2015 | K152169 | Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts | JWH | Substantially Equivalent | Ortho Development Corporation | accessdata.fda.gov |
| December 11, 2014 | K142146 | IBIS PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| July 30, 2014 | K141001 | ALPINE HIP STEM; ALPINE HA HIP STEM | LPH | Substantially Equivalent | Ortho Development | accessdata.fda.gov |
| June 20, 2014 | K132697 | ENCOMPASS 10/12 HIP STEM | LPH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| March 11, 2014 | K133386 | OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM | LPH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| February 18, 2014 | K133449 | KASM KNEE ARTICULATING SPACER MOLDS | JWH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| October 16, 2013 | K131022 | OVATION 10/12 HIP STEM | LPH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| October 11, 2013 | K131337 | BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA | JWH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| August 20, 2013 | K131785 | PAGODA PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| June 12, 2013 | K122588 | VUSION CS PLUS | ODP | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| March 22, 2013 | K123457 | BALANCED KNEE SYSTEM HIGH FLEX PS | JWH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| October 25, 2011 | K111965 | VUSION(R) OS | MAX | Substantially Equivalent | Ortho Development | accessdata.fda.gov |
| September 21, 2011 | K111936 | ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD | LZO | Substantially Equivalent | Ortho Development | accessdata.fda.gov |
| March 24, 2011 | K103837 | BALANCED KNEE SYSTEM REVISION OFFSET TIBIA | JWH | Substantially Equivalent | Ortho Development | accessdata.fda.gov |
| March 16, 2011 | K103384 | ESCALADE ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | Ortho Development | accessdata.fda.gov |
| October 9, 2009 | K090705 | BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT | JWH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| January 25, 2007 | K062666 | VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS | MQP | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| January 16, 2007 | K062775 | EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM | LPH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| September 26, 2006 | K061524 | ISS INTEGRATED SPINE SYSTEM | MNH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| July 6, 2006 | K060569 | BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM | JWH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| April 28, 2006 | K060577 | ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| March 17, 2006 | K053587 | ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS | LZO | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| February 16, 2006 | K053293 | ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS | LPH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| September 23, 2005 | K050637 | ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS | JDI | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| September 8, 2005 | K051407 | LEGEND ALL-POLY CUP | JDI | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| July 7, 2005 | K050966 | PIVOT BIPOLAR FEMORAL HEAD | KWY | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| April 11, 2005 | K042565 | ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER | LPH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| January 27, 2005 | K042973 | SOLITUDE UNIPOLAR HEAD | KWL | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| July 15, 2003 | K031201 | ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM | JWH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| May 6, 2002 | K020383 | ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED | JWH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| April 5, 2002 | K020649 | ENVISION ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| April 10, 2000 | K000321 | HEMISPHERE MODULAR CUP SYSTEM | LPH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| March 24, 2000 | K994370 | ORTHO DEVELOPMENT BALANCED KNEE SYSTEM | JWH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| October 14, 1999 | K990986 | CONTOUR SPINAL SYSTEM | KWP | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| October 7, 1998 | K982389 | ODC B2 BIPOLAR CUP | KWY | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| August 22, 1997 | K970675 | HEADLOC CERAMIC HEAD | LZO | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| July 9, 1997 | K971435 | HEADLOC CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| July 9, 1997 | K971426 | HEADLOC CERAMIC HEAD | LZO | Substantially Equivalent for Some Indications | Ortho Development Corp. | accessdata.fda.gov |
| September 19, 1996 | K962448 | PRIMALOC CEMENTED HIP SYSTEM | KWY | Substantially Equivalent for Some Indications | Ortho Development Corp. | accessdata.fda.gov |
| May 8, 1996 | K960660 | HEMISPHERE ACETABULAR CUP | LPH | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| January 26, 1996 | K953977 | PRIMALOC CEMENTLESS HIP SYSTEM | KWY | Substantially Equivalent | Ortho Development Corp. | accessdata.fda.gov |
| January 27, 1992 | K913708 | VENUS HIP | LWJ | Substantially Equivalent | Turnkey Intergration USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Tape, Measuring, Rulers And Calipers
- All makers of Forceps
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal
Updated December 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.