Cleared Traditional

K961051 - UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)

K961051 is an FDA 510(k) clearance for UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION), manufactured by Kinetikos Medical, Inc.. The device is a Class 2 Orthopedic device with product code JWJ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K961051 · Kinetikos Medical, Inc. · Orthopedic device
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Jun 1996
Decision
87d
Days
Class 2
Risk

K961051 is an FDA 510(k) clearance for the UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION). Classified as Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (product code JWJ), Class II - Special Controls.

Submitted by Kinetikos Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on June 6, 1996 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3800 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kinetikos Medical, Inc. devices

FDA 510(k) Submission Details - K961051

510(k) Number K961051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date June 06, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWJ Device Classification - Class 2, Special Controls

Product Code JWJ Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3800
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 - JWJ Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained

All 16
Devices cleared under the same product code (JWJ) and FDA review panel - the closest regulatory comparables to K961051.
WRIST IMPLANT
K021859 · Avanta Orthopaedics, Inc. · Dec 2002
MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
K020554 · Kinetikos Medical, Inc. · May 2002
PASCO MIC AND MIC/ID PANELS/ CEFDINIR
K982156 · Pasco Laboratories, Inc. · Jul 1998
THE RICHARDS WRIST
K931131 · Smith & Nephew Richards, Inc. · Aug 1994
MINI MICK APPLICATOR
K802032 · Mick Radio-Nuclear Instruments, Inc. · Oct 1980
HAMAS PRECENTERED TOTAL WRIST
K792650 · Zimmer, Inc. · Jan 1980