# Osteomed LP

- Location (FDA's records): Addison, TX
- FDA decisions: 73 (1991–2022): 73 510(k) clearances
- Names in FDA's records: Osteomed LP (29); Osteomed Corp. (27); Osteomed (12); Osteomed, LLC (5)
- Product codes: HWC (15), HRS (12), MQN (7), JEY (7), DZL (5), KWD (3), KWH (2), KMW (2), PBJ (2), KCT (2), DZE (2), DZJ (1)
- 510(k) review time since 2016: median 92 days, against 127 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 143 (50 its own); citations of its devices by later devices: 172 (50 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 17 (https://510kreport.com/company/synthes-usa)
- KLS-Martin L.P.: 12 (https://510kreport.com/company/kls-martin)
- Howmedica Leibinger, Inc.: 7 (https://510kreport.com/company/howmedica-leibinger)
- Walter Lorenz Surgical, Inc.: 6 (https://510kreport.com/company/walter-lorenz-surgical)
- Stryker Leibinger GmbH & Co KG: 4 (https://510kreport.com/company/stryker-leibinger)
- Stryker Instruments: 3 (https://510kreport.com/company/stryker-instruments)
- Medical Modeling, Inc.: 2 (https://510kreport.com/company/medical-modeling)
- Kinetikos Medical, Inc.: 2 (https://510kreport.com/company/kinetikos-medical)

## Firms that cite its devices most
- Trilliant Surgical, Ltd.: 6 (https://510kreport.com/company/trilliant-surgical)
- Acumed, LLC: 6 (https://510kreport.com/company/acumed)
- Landos, Inc.: 4 (https://510kreport.com/company/landos)
- Eminent Spine: 4 (https://510kreport.com/company/eminent-spine)
- Extremity Medical, LLC: 3 (https://510kreport.com/company/extremity-medical)
- KLS-Martin L.P.: 3 (https://510kreport.com/company/kls-martin)
- Instratek, Inc.: 3 (https://510kreport.com/company/instratek)
- Internal Fixation Systems, Inc.: 2 (https://510kreport.com/company/internal-fixation-systems)

## Its most-cited devices
- K063298: Osteomed Headless Cannulated Screw System (2007), cited by 13
- K091614: Osteomed Foot Plating System (2009), cited by 13
- K924018: M3 Lag Screw Fixation System (1993), cited by 12
- K100354: Primal OK Interspinous Fusion System (2010), cited by 8
- K031936: Osteomed Orthodontic Screw System (2004), cited by 8
- K062863: Osteomed Extended 2.0/2.4CANNULATED Screw System (2006), cited by 8

## Recent decisions
- K212570: OsteoPlan System (Feb 11, 2022)
- K203479: ExtremiLOCK Lateral Ankle Fusion Plates (Feb 24, 2021)
- K202105: OsteoMed ExtremiFix Mini & Small System Tray (Oct 29, 2020)
- K202680: OsteoMed ExtremiFix Mini & Small Cannulated Screw System (Oct 15, 2020)
- K173391: OsteoMed QuickFix Hybrid MMF Sterilization Tray (May 10, 2018)
- K162542: OsteoMed PINNACLE Driver (May 19, 2017)
- K163303: OsteoMed ExtremiFix Mid and Large Screw System (Apr 4, 2017)
- K162544: OsteoMed PINNACLE Driver (Apr 4, 2017)

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