Cleared Traditional

K011857 - SYNTHES (USA) TROCHANTERIC FIXATION NAI...

K011857 is the FDA 510(k) clearance for SYNTHES (USA) TROCHANTERIC FIXATION NAI... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K011857 · Synthes (Usa) · Orthopedic device
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Sep 2001
Decision
90d
Days
Class 2
Risk

K011857 is an FDA 510(k) clearance for the SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on September 12, 2001 after a review of 90 days - within the typical 510(k) review window.

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: 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 K011857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2001
Decision Date September 12, 2001
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K011857.
ACE BIO WIN TIBIAL NAILING SYSTEM
K013430 · DePuy Orthopaedics, Inc. · Dec 2001
LONG LENGTH DYAX NAIL
K013468 · Howmedica Osteonics Corp. · Nov 2001
TROCHANTERIC DYAX NAIL SYSTEM
K013524 · Howmedica Osteonics Corp. · Nov 2001
MODIFICATION TO: LONG LENGTH GAMMA NAIL
K012158 · Howmedica Osteonics Corp. · Aug 2001
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS
K011622 · Howmedica Osteonics Corp. · Jun 2001
TROCHANTERIC NAIL
K010780 · DePuy Orthopaedics, Inc. · Jun 2001