# Osteonics Corp.

- Location (FDA's records): Allendale, NJ
- FDA decisions: 178 (1980–2000): 178 510(k) clearances
- Product codes: JDI (29), MEH (24), JWH (24), LZO (10), KWL (8), HWC (8), LPH (7), KWS (7), HRS (6), JDK (6), LWJ (6), MNH (5)
- Predicates its devices cite: 12 (5 its own); citations of its devices by later devices: 178 (5 its own)
- Recalls linked to its devices: 131 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Howmedica Corp.: 3 (https://510kreport.com/company/howmedica)
- American Medical Electronics, Inc.: 1 (https://510kreport.com/company/american-medical-electronics)
- Osteo AG: 1 (https://510kreport.com/company/osteo)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)
- Levtech, Inc.: 1 (https://510kreport.com/company/levtech)

## Firms that cite its devices most
- Howmedica Osteonics Corp.: 59 (https://510kreport.com/company/howmedica-osteonics)
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics: 15 (https://510kreport.com/company/howmedica-osteonics-dba-stryker-orthopaedics)
- Stryker Orthopaedics: 14 (https://510kreport.com/company/stryker-orthopaedics)
- Biomet, Inc.: 9 (https://510kreport.com/company/biomet)
- Stryker Spine: 7 (https://510kreport.com/company/stryker-spine)
- Aesculap, Inc.: 7 (https://510kreport.com/company/aesculap)
- United Orthopedic Corporation: 6 (https://510kreport.com/company/united-orthopedic)
- Corin USA: 4 (https://510kreport.com/company/corin-usa)

## Its most-cited devices
- K951725: Osteonics Spinal System (1995), cited by 16
- K974556: Osteonics Scorpio Posterior Cruciate Retaining Total Knee System (1998), cited by 12
- K962152: Osteonics Scorpio Posteriorly Stabilized Total Knee System (1996), cited by 10
- K983382: Osteonics HA Generation II Acetabular Component System (1998), cited by 10
- K800207: Uhr UNIVERSAL6HIP Replacement (1980), cited by 6
- K910988: Osteonics Ion Implanted Femoral Bearing Series (1991), cited by 5

## Recent decisions
- K983657: Osteonics Series 7000 AD Tibial Tray (Apr 6, 2000)
- K980070: Osteonics HA-Coated Devices (Jul 23, 1999)
- K984375: Osteonics Spinal System - Sacral Offset Connector Assembly (Apr 30, 1999)
- K982798: Osteonics Anterior Cervical Compression Plating System (Mar 25, 1999)
- K984585: Osteonics +10 Unipolar Adaptor Sleeve (Feb 24, 1999)
- K990203: Osteonics Primary Secur-Fit Plus Hip Stems (Feb 18, 1999)
- K990158: Osteonics Combination Screw Ring/Blocker (Feb 1, 1999)
- K984302: Osteonics Spinal System Cylindrical Bone Screws (Dec 18, 1998)

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