Cleared Traditional

K954963 - SCHUHLI IMPLANT SYSTEM

K954963 is the FDA 510(k) clearance for SCHUHLI IMPLANT SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K954963 · Synthes (Usa) · Orthopedic device
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Mar 1996
Decision
144d
Days
Class 2
Risk

K954963 is an FDA 510(k) clearance for the SCHUHLI IMPLANT SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 22, 1996 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Synthes (Usa) devices

Submission Details

510(k) Number K954963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date March 22, 1996
Days to Decision 144 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
22d slower than avg
Panel avg: 122d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 904
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K954963.
R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM
K961496 · Howmedica, Inc. · Jun 1996
PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K961497 · Howmedica, Inc. · Jun 1996
FOREFOOT RECONSTRUCTION SYSTEM
K961485 · Howmedica Corp. · Jun 1996
VOLAR DISTAL RADIUS PLATE
K953644 · Synthes (Usa) · Mar 1996
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE
K953714 · Zimmer, Inc. · Nov 1995
LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW
K951415 · Howmedica Corp. · Jun 1995