Cleared Traditional

K092646 - SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW

K092646 is an FDA 510(k) clearance for SYNTHES (USA) TROCHANTERIC FIXATION NAI..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K092646 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
28d
Days
Class 2
Risk

K092646 is an FDA 510(k) clearance for the SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on September 25, 2009 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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.

FDA 510(k) Submission Details - K092646

510(k) Number K092646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2009
Decision Date September 25, 2009
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 530
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K092646.
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K092646 · SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW
Download PDF FDA Summary Synthes (Usa)