# Ortho Development Corp.

- Location (FDA's records): Draper, UT
- FDA decisions: 64 (1996–2025): 64 510(k) clearances
- Names in FDA's records: Ortho Development Corp. (45); Ortho Development Corporation (14); Ortho Development (5)
- Product codes: JWH (15), LPH (13), LZO (6), KWY (5), JDI (4), NKB (4), MEH (3), GEI (2), KWP (1), HSX (1), MBH (1), OWI (1)
- 510(k) review time since 2016: median 98 days, against 90 for FDA's reviews in the same codes and years (9 of 18 faster)
- Predicates its devices cite: 107 (36 its own); citations of its devices by later devices: 53 (36 its own)
- Recalls linked to its devices: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- DePuy Orthopaedics, Inc.: 9 (https://510kreport.com/company/depuy-orthopaedics)
- Biomet, Inc.: 8 (https://510kreport.com/company/biomet)
- Smith & Nephew, Inc.: 7 (https://510kreport.com/company/smith-nephew)
- Zimmer, Inc.: 3 (https://510kreport.com/company/zimmer)
- Howmedica Osteonics Corp.: 2 (https://510kreport.com/company/howmedica-osteonics)
- Encore Medical L.P.: 2 (https://510kreport.com/company/encore-medical)
- Smith & Nephew Richards, Inc.: 2 (https://510kreport.com/company/smith-nephew-richards)
- Exactech, Inc.: 2 (https://510kreport.com/company/exactech)

## Firms that cite its devices most
- Total Joint Orthopedics, Inc.: 2 (https://510kreport.com/company/total-joint-orthopedics)
- Spinecraft, LLC: 2 (https://510kreport.com/company/spinecraft)
- Medacta International S.A.: 2 (https://510kreport.com/company/medacta-international)
- Fournitures Hospitalieres: 2 (https://510kreport.com/company/fournitures-hospitalieres)
- Paonan Biotech Co., Ltd.: 2 (https://510kreport.com/company/paonan-biotech)
- Responsive Orthopedics, LLC: 1 (https://510kreport.com/company/responsive-orthopedics)
- United Orthopedic Corporation: 1 (https://510kreport.com/company/united-orthopedic)
- Corin USA: 1 (https://510kreport.com/company/corin-usa)

## Its most-cited devices
- K994370: Ortho Development Balanced Knee System (2000), cited by 6
- K062775: European Style Taper,Press-Fit Hip Stem (2007), cited by 4
- K123457: Balanced Knee System High Flex PS (2013), cited by 3
- K131785: Pagoda Pedicle Screw System (2013), cited by 3
- K953977: Primaloc Cementless Hip System (1996), cited by 3
- K142146: Ibis Pedicle Screw System (2014), cited by 3

## Recent decisions
- K253161: Balanced Knee System TriMax Porous Femoral Components (Dec 19, 2025)
- K251052: Trivicta® Hip Stem (May 22, 2025)
- K242984: BKS Revision System (Oct 25, 2024)
- K242833: Legend® Acetabular Shell (Oct 11, 2024)
- K233758: Trivicta™ Hip Stem (Mar 8, 2024)
- K233093: Balanced Knee® System TriMax PS Plus Tibial Insert (Oct 25, 2023)
- K211086: The Progen™ Trochanteric Nail System (Dec 21, 2021)
- K211471: Balanced Knee System Uni (Dec 16, 2021)

Source page: https://510kreport.com/company/ortho-development