Cleared Traditional

DEPUY MOTECH PEAK FIXATION SYSTEM (K963350) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963350 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
80d
Days
Class 2
Risk

K963350 is an FDA 510(k) clearance for the DEPUY MOTECH PEAK FIXATION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 14, 1996 after a review of 80 days - a notably fast clearance cycle.

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: 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 Depuy, Inc. devices

Submission Details

510(k) Number K963350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1996
Decision Date November 14, 1996
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 403
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K963350.
BIOMET BONE SCREW
K964970 · Biomet, Inc. · Apr 1997
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
K965073 · Smith & Nephew, Inc. · Feb 1997
HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)
K955733 · Depuy, Inc. · Nov 1996
SYNTHES STERILE 4.5 MM CANNULATED SCREWS
K963172 · Synthes (Usa) · Nov 1996
SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS
K963192 · Synthes (Usa) · Nov 1996
ALTA FULLY THREADED CROSS-LOCKING SCREWS
K963398 · Howmedica Corp. · Oct 1996