Cleared Traditional

BIOMET FEMORAL LOCKING NAIL SYSTEM (K072161) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072161 · Biomet Manufacturing Corp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
45d
Days
Class 2
Risk

K072161 is an FDA 510(k) clearance for the BIOMET FEMORAL LOCKING NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on September 20, 2007 after a review of 45 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.

View all Biomet Manufacturing Corp devices

Submission Details

510(k) Number K072161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date September 20, 2007
Days to Decision 45 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 122d · This submission: 45d
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 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K072161.
SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM
K081452 · Synthes (Usa) · Jul 2008
T2 FEMORAL NAIL
K081152 · Howmedica Osteonics Corp. · Jun 2008
SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM
K073402 · Synthes (Usa) · Feb 2008
SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM
K070843 · Synthes (Usa) · May 2007
SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES
K070294 · Synthes (Usa) · Mar 2007
METAIZEAU NAILING SYSTEM
K063225 · Howmedica Osteonics Corp. · Dec 2006