Cleared Traditional

K963192 - SYNTHES STERILE 3.5 MM AND 4.0 MM CANNU...

K963192 is the FDA 510(k) clearance for SYNTHES STERILE 3.5 MM AND 4.0 MM CANNU... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K963192 · Synthes (Usa) · Orthopedic device
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Nov 1996
Decision
85d
Days
Class 2
Risk

K963192 is an FDA 510(k) clearance for the SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on November 8, 1996 after a review of 85 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 Synthes (Usa) devices

Submission Details

510(k) Number K963192 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 15, 1996
Decision Date November 08, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
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 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K963192.
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K960652 · Linvatec Corp. · Nov 1996
DEPUY MOTECH PEAK FIXATION SYSTEM
K963350 · Depuy, Inc. · Nov 1996
SYNTHES STERILE 4.5 MM CANNULATED SCREWS
K963172 · Synthes (Usa) · Nov 1996
EXTREMITY BONE SCREW
K963118 · Acu Med, Inc. · Oct 1996
ALTA FULLY THREADED CROSS-LOCKING SCREWS
K963398 · Howmedica Corp. · Oct 1996
SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER
K962823 · Synthes (Usa) · Oct 1996