Cleared Special

K070294 - SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES

K070294 is an FDA 510(k) clearance for SYNTHES TROCHANTERIC FIXATION NAIL (TFN..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 29-day FDA review.

K070294 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
29d
Days
Class 2
Risk

K070294 is an FDA 510(k) clearance for the SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES. 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 March 1, 2007 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070294

510(k) Number K070294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2007
Decision Date March 01, 2007
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K070294.
ACUMED SMALL BONE LOCKING SYSTEM II
K071944 · Acumed, LLC · Aug 2007
AOS TIBIAL NAIL
K070444 · Advanced Orthopaedic Solutions, Inc. · Jun 2007
SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM
K070843 · Synthes (Usa) · May 2007
BIOMET TIBIAL LOCKING NAIL SYSTEM
K063570 · Biomet Manufacturing Corp · Feb 2007
METAIZEAU NAILING SYSTEM
K063225 · Howmedica Osteonics Corp. · Dec 2006
SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)
K061910 · Synthes (Usa) · Sep 2006
K070294 · SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES
Download PDF FDA Summary Synthes (Usa)