# Howmedica Osteonics Corp.

- Location (FDA's records): Allendale, NJ
- FDA decisions: 303 (1997–2020): 301 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Howmedica Osteonics Corp. (290); Howmedica Osteonics (13)
- Product codes: HSB (39), JWH (32), LZO (24), MEH (19), KTT (19), JDI (17), LPH (16), HRS (16), KWQ (10), MNH (9), KRO (9), MBH (9)
- Predicates its devices cite: 302 (129 its own); citations of its devices by later devices: 867 (129 its own)
- Recalls linked to its devices: 281 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Osteonics Corp.: 59 (https://510kreport.com/company/osteonics)
- Howmedica Corp.: 54 (https://510kreport.com/company/howmedica)
- Biomet, Inc.: 6 (https://510kreport.com/company/biomet)
- Stryker Corp.: 6 (https://510kreport.com/company/stryker)
- DePuy Orthopaedics, Inc.: 5 (https://510kreport.com/company/depuy-orthopaedics)
- Stryker Orthopaedics: 5 (https://510kreport.com/company/stryker-orthopaedics)
- Stryker Instruments: 3 (https://510kreport.com/company/stryker-instruments)
- Vilex, LLC: 3 (https://510kreport.com/company/vilex)

## Firms that cite its devices most
- Stryker Orthopaedics: 102 (https://510kreport.com/company/stryker-orthopaedics)
- Stryker Corp.: 61 (https://510kreport.com/company/stryker)
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics: 57 (https://510kreport.com/company/howmedica-osteonics-dba-stryker-orthopaedics)
- Stryker Spine: 52 (https://510kreport.com/company/stryker-spine)
- Stryker Trauma AG: 27 (https://510kreport.com/company/stryker-trauma)
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics: 16 (https://510kreport.com/company/howmedica-osteonics-aka-stryker-orthopaedics)
- Smith & Nephew, Inc.: 14 (https://510kreport.com/company/smith-nephew)
- Aesculap, Inc.: 14 (https://510kreport.com/company/aesculap)

## Its most-cited devices
- K000080: Asnis Iii Cannulated Screw System (2000), cited by 21
- K013823: Xia Spinal System (2001), cited by 18
- K040267: Triathlon Cruciate Retaining (CR) Total Knee (2004), cited by 17
- K043431: GAMMA3 Nail System (2005), cited by 16
- K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System (2003), cited by 15
- K032394: Stryker Spine Oasys System (2004), cited by 14

## Recent decisions
- K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (Aug 13, 2020)
- K200782: Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite (May 13, 2020)
- K130895: Reunion Rsa Shoulder System (Dec 27, 2013)
- K123604: Abg Iii Monolithic Hip Stem (Aug 16, 2013)
- K122015: Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip, Wedge (Feb 22, 2013)
- K123166: Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P (Feb 14, 2013)
- K122853: Novel Fit and Fill Stem (Feb 1, 2013)
- K121315: Stryker CMF Medpor Customized Implant (Nov 1, 2012)

Source page: https://510kreport.com/company/howmedica-osteonics