Hand Biomechanics Lab, Inc.

• JEC — Orthopedic4 devices
• HRX — Orthopedic2 devices
• HTW — Orthopedic1 device
• JDW — Orthopedic1 device
• KTT — Orthopedic1 device

• Z-0136-2017 — Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.Class II·Terminated·2016-09-14

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyCode HRX·2025-10-15
• K222490 — HBL Blade AssemblyCode HRX·2022-11-14
• K181192 — PIP FixCode JEC·2018-10-22
• K072432 — F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILECode JEC·2008-01-09
• K033112 — WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NSCode KTT·2003-11-05
• K030519 — WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNSCode JEC·2003-06-10
• K992970 — DIGIT WIDGETCode JDW·1999-11-08
• K984442 — AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147Code JEC·1999-02-12
• K942906 — AGEE-WRISTJACK PRE-DRILL KITCode HTW·1994-12-22