# Biomet Trauma

- Location (FDA's records): Parsippany, NJ
- FDA decisions: 7 (2007–2009): 7 510(k) clearances
- Product codes: HRS (3), HSB (2), HWC (1), KTT (1)
- Predicates its devices cite: 52 (0 its own); citations of its devices by later devices: 20 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ebi, L.P.: 31 (https://510kreport.com/company/ebi)
- Synthes (Usa): 6 (https://510kreport.com/company/synthes-usa)
- Biomet Orthopedics, Inc.: 4 (https://510kreport.com/company/biomet-orthopedics)
- Electro-Biology, Inc.: 4 (https://510kreport.com/company/electro-biology)
- Howmedica Osteonics Corp.: 2 (https://510kreport.com/company/howmedica-osteonics)
- Biomet Manufacturing Corp: 1 (https://510kreport.com/company/biomet-manufacturing)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- Encore Orthopedics, Inc.: 1 (https://510kreport.com/company/encore-orthopedics)

## Firms that cite its devices most
- Biomet, Inc.: 3 (https://510kreport.com/company/biomet)
- CarboFix Orthopedics, Ltd.: 2 (https://510kreport.com/company/carbofix-orthopedics)
- Force Medical, Inc.: 2 (https://510kreport.com/company/force-medical)
- Ortho Solutions Limited: 2 (https://510kreport.com/company/ortho-solutions)
- Biomet Trauma (Aka Ebi, Lp): 1 (https://510kreport.com/company/biomet-trauma-aka-ebi)
- Vilex, LLC: 1 (https://510kreport.com/company/vilex)
- Tecnologia Y Diseno Industrial, S.A DE C.V: 1 (https://510kreport.com/company/tecnologia-y-diseno-industrial-s-a-de-c-v)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)

## Its most-cited devices
- K091976: Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail (2009), cited by 6
- K082874: Biodrive Cannulated Screw System (2009), cited by 6
- K081243: Biomet Phoenix Ankle Nail System (2008), cited by 3
- K070823: Growth Control Plating System (2007), cited by 2
- K081244: Lower Extremity External Fixation - Expanded Indications (2008), cited by 2
- K092078: Optilock Periarticular Plating (2009), cited by 1

## Recent decisions
- K091976: Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail (Aug 17, 2009)
- K092078: Optilock Periarticular Plating (Aug 5, 2009)
- K082874: Biodrive Cannulated Screw System (Feb 5, 2009)
- K081244: Lower Extremity External Fixation - Expanded Indications (Jul 30, 2008)
- K081243: Biomet Phoenix Ankle Nail System (Jun 27, 2008)
- K071325: Biomet Variable Locking Plate System (Jul 26, 2007)
- K070823: Growth Control Plating System (May 7, 2007)

Source page: https://510kreport.com/company/biomet-trauma
