Cleared Traditional

K090949 - SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS

K090949 is an FDA 510(k) clearance for SYNTHES (USA) 1.5MM HEADLESS COMPRESSIO..., 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 119-day FDA review.

K090949 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
119d
Days
Class 2
Risk

K090949 is an FDA 510(k) clearance for the SYNTHES (USA) 1.5MM 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 July 31, 2009 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes (Usa) devices

FDA 510(k) Submission Details - K090949

510(k) Number K090949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2009
Decision Date July 31, 2009
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
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 927
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K090949.
ASCENSION CANNULATED SCREW SYSTEM
K092440 · Ascension Orthopedics, Inc. · Nov 2009
PARCUS PPEK CF INTERFERENCE SCREW
K091093 · Parcus Medical, LLC · Sep 2009
MERETE COMPRESSION SCREWS
K091798 · Merete Medical GmbH · Sep 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM
K091577 · Extremity Medical, LLC · Jul 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656 · Smith & Nephew, Inc. · Jun 2009
MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT
K091069 · Medacta International S.A. · Jun 2009