Cleared Traditional

K092909 - SYNTHES 7.3 MM CANNULATED SLIPPED CAPIT...

K092909 is the FDA 510(k) clearance for SYNTHES 7.3 MM CANNULATED SLIPPED CAPIT... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K092909 · Synthes (Usa) · Orthopedic device
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Jan 2010
Decision
111d
Days
Class 2
Risk

K092909 is an FDA 510(k) clearance for the SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE). 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 January 11, 2010 after a review of 111 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

Submission Details

510(k) Number K092909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2009
Decision Date January 11, 2010
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 K092909.
OPUS SPEEDSCREW SYSTEM
K100457 · Arthrocare Corp. · Mar 2010
OMNITECH LARGE, TRIMED COMPRESSION SCREW
K093676 · TriMed, Inc. · Mar 2010
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819
K100532 · Depuy Mitek, A Johnson & Johnson Company · Mar 2010
FOOT AND HAND MOTION SYSTEM
K091118 · Newclip Technics · Dec 2009
LEFORTE NEUROSYSTEM BONE SCREW
K091686 · Jeil Medical Corporation · Nov 2009
ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N
K092133 · Arthrocare Corp. · Nov 2009