# Biomet Microfixation

- Location (FDA's records): Jacksonville, FL
- FDA decisions: 31 (2005–2026): 30 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Biomet Microfixation (25); Biomet Microfixation, Inc. (6)
- Product codes: HRS (15), JEY (8), HBE (2), HWC (2), LZD (1), GXR (1), OCV (1), GWO (1)
- 510(k) review time since 2016: median 98 days, against 109 for FDA's reviews in the same codes and years (6 of 11 faster)
- Predicates its devices cite: 58 (18 its own); citations of its devices by later devices: 59 (18 its own)
- Recalls linked to its devices: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Walter Lorenz Surgical, Inc.: 23 (https://510kreport.com/company/walter-lorenz-surgical)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Biomet Micofixation: 2 (https://510kreport.com/company/biomet-micofixation)
- ETHICON, Inc.: 2 (https://510kreport.com/company/ethicon)
- Dmetec.Co., Ltd.: 1 (https://510kreport.com/company/dmetec)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)

## Firms that cite its devices most
- Jeil Medical Corporation: 5 (https://510kreport.com/company/jeil-medical)
- Jace Medical, LLC: 4 (https://510kreport.com/company/jace-medical)
- Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices: 4 (https://510kreport.com/company/jm-longyear-manufacturing-dba-able-medical-devices)
- Sig Medical Corp.: 2 (https://510kreport.com/company/sig-medical)
- Pioneer Surgical Technology: 2 (https://510kreport.com/company/pioneer-surgical-technology)
- Osteonic Co., Ltd.: 2 (https://510kreport.com/company/osteonic)
- KLS-Martin L.P.: 2 (https://510kreport.com/company/kls-martin)
- A & E Medical Corporation: 2 (https://510kreport.com/company/a-e-medical)

## Its most-cited devices
- K121302: Biomet Microfixation Sternal Closure System (2012), cited by 8
- K110574: Biomet Microfixation Sternalock Blu Sternal Closure System (2011), cited by 8
- K111908: Biomet Microfixation Sternal Closure System (2011), cited by 6
- K212608: RibFix Blu Thoracic Fixation System (2022), cited by 4
- K161896: Biomet Microfixation Sternal Closure System (2016), cited by 4
- K142823: Biomet Microfixation Thoracic Fixation System (2015), cited by 4

## Recent decisions
- K261002: Pectus Blu System (Jun 2, 2026)
- K241709: Pectus Blu Support Bar System (Sep 19, 2024)
- K223199: 2.1 x 255mm Drill, 22mm Stop (Nov 15, 2022)
- K212782: SternaLock Sternal Closure System (May 17, 2022)
- K212608: RibFix Blu Thoracic Fixation System (Apr 22, 2022)
- K213712: Pectus Support Bar System (Mar 11, 2022)
- K213208: Twist Drills (Dec 23, 2021)
- K202969: Biomet Microfixation OmniMax MMF System (Aug 5, 2021)

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