Cleared Traditional

K981372 - SYNTHES 3.0 MM PC-FIX SYSTEM

K981372 is the FDA 510(k) clearance for SYNTHES 3.0 MM PC-FIX SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K981372 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
25d
Days
Class 2
Risk

K981372 is an FDA 510(k) clearance for the SYNTHES 3.0 MM PC-FIX SYSTEM. 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 May 11, 1998 after a review of 25 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 K981372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1998
Decision Date May 11, 1998
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
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 K981372.
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
K981670 · Depuy, Inc. · Jun 1998
RCI FIXATION SCREWS
K980841 · Smith & Nephew, Inc. · May 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K981259 · Osteonics Corp. · May 1998
HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS
K980364 · Howmedica Corp. · Apr 1998
INNOVASIVE DEVICES MENISCAL SCREW
K980681 · Innovasive Devices, Inc. · Apr 1998
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW
K980440 · Depuy, Inc. · Apr 1998