Cleared Traditional

K080943 - SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMP...

K080943 is the FDA 510(k) clearance for SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMP... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K080943 · Synthes (Usa) · Orthopedic device
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Apr 2008
Decision
20d
Days
Class 2
Risk

K080943 is an FDA 510(k) clearance for the SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on April 23, 2008 after a review of 20 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 K080943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2008
Decision Date April 23, 2008
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
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 K080943.
BIOPRO GO-EZ SCREW
K081149 · Biopro, Inc. · Aug 2008
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700 · Synthes (Usa) · Jul 2008
SYNTHES 6.5MM MIDFOOT FUSION BOLT
K081071 · Synthes (Usa) · May 2008
DARCO HEADLESS COMPRESSION SCREW
K080850 · Wrightmedicaltechnologyinc · Apr 2008
AAP CANNULATED SCREW AND DARCO HEADED SCREW
K080101 · Aap Implantate AG · Mar 2008
MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE
K080352 · Depuy Mitek, A Johnson & Johnson Company · Mar 2008