Cleared Traditional

K963192 - SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS

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

K963192 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K963192

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.

HWC Device Classification - Class 2, Special Controls

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 923
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K963192.
DEPUY MOTECH PEAK FIXATION SYSTEM
K963350 · Depuy, Inc. · Nov 1996
EZ-FIX CANNULATED SCREW SYSTEM
K962706 · Biodynamic Technologies, Inc. · Nov 1996
SYNTHES STERILE 4.5 MM CANNULATED SCREWS
K963172 · Synthes (Usa) · Nov 1996
EZ-FIX SMALL CANNULATED SCREW SYSTEM
K962987 · Biodynamic Technologies, Inc. · Nov 1996
EXTREMITY BONE SCREW
K963118 · Acu Med, Inc. · Oct 1996
ALTA FULLY THREADED CROSS-LOCKING SCREWS
K963398 · Howmedica Corp. · Oct 1996