Cleared Traditional

K030519 - WRISTJACK SYSTEM (REMANUFACTURED)

K030519 is an FDA 510(k) clearance for WRISTJACK SYSTEM (REMANUFACTURED), manufactured by Hand Biomechanics Lab, Inc.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K030519 · Hand Biomechanics Lab, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2003
Decision
111d
Days
Class 2
Risk

K030519 is an FDA 510(k) clearance for the WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS.... Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Hand Biomechanics Lab, Inc. (Sacramento, US). The FDA issued a Cleared decision on June 10, 2003 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Hand Biomechanics Lab, Inc. devices

FDA 510(k) Submission Details - K030519

510(k) Number K030519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date June 10, 2003
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JEC Component, Traction, Invasive

All 47
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K030519.
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
K071476 · Synthes (Usa) · Aug 2007
KLSA MARTIN HAND DISTRACTOR
K042066 · KLS-Martin L.P. · Aug 2004
HOFFMANN II COMPACT BALTIMORE COUPLING
K031941 · Howmedica Osteonics Corp. · Jul 2003
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676 · Smith & Nephew, Inc. · Sep 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193 · Smith & Nephew, Inc. · Jul 2002
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
K003848 · Howmedica Osteonics Corp. · Jan 2001