# Hand Biomechanics Lab, Inc.

- Location (FDA's records): Sacramento, CA
- FDA decisions: 9 (1994–2025): 9 510(k) clearances
- Product codes: JEC (4), HRX (2), HTW (1), KTT (1), JDW (1)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 6 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew, Inc., Orthopaedic Div.: 2 (https://510kreport.com/company/smith-nephew-orthopaedic-div)
- Microaire Surgical Instruments, LLC: 2 (https://510kreport.com/company/microaire-surgical-instruments)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- The Hand Biomechanics Research Laboratory: 1 (https://510kreport.com/company/hand-biomechanics-research-laboratory)

## Firms that cite its devices most
- Rigid FX Orthopedics, Incorporated: 1 (https://510kreport.com/company/rigid-fx-orthopedics)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)

## Its most-cited devices
- K984442: Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147 (1999), cited by 2
- K942906: Agee-Wristjack Pre-Drill Kit (1994), cited by 1
- K072432: F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non Sterile (2008), cited by 1
- K992970: Digit Widget (1999), cited by 1
- K222490: HBL Blade Assembly (2022), cited by 1

## Recent decisions
- K252020: TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (Oct 15, 2025)
- K222490: HBL Blade Assembly (Nov 14, 2022)
- K181192: PIP Fix (Oct 22, 2018)
- K072432: F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non Sterile (Jan 9, 2008)
- K033112: Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NS (Nov 5, 2003)
- K030519: Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNS (Jun 10, 2003)
- K992970: Digit Widget (Nov 8, 1999)
- K984442: Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147 (Feb 12, 1999)

Source page: https://510kreport.com/company/hand-biomechanics-lab