Cleared Traditional

K050636 - SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS

K050636 is the FDA 510(k) clearance for SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS by Synthes (Usa). It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K050636 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2005
Decision
41d
Days
Class 2
Risk

K050636 is an FDA 510(k) clearance for the SYNTHES 3.0MM 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 21, 2005 after a review of 41 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 K050636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2005
Decision Date April 21, 2005
Days to Decision 41 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
81d faster than avg
Panel avg: 122d · This submission: 41d
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 K050636.
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
K051098 · Zimmer, Inc. · Jul 2005
ARTHREX TAK FAMILY
K050749 · Arthrex, Inc. · May 2005
SYNTHES (USA) 3.5MM CONICAL SCREWS
K050683 · Synthes (Usa) · Apr 2005
ARTHERX CORKSCREW FT II SUTURE ANCHOR
K050358 · Arthrex, Inc. · Apr 2005
CHARLOTTE SNAP-OFF SCREW
K050819 · Wrightmedicaltechnologyinc · Apr 2005
BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET
K050497 · Linvatec Corp. · Mar 2005