Cleared Traditional

K013923 - TITANIUM RETROGRADE FEMORAL NAIL - 13 M...

K013923 is an FDA 510(k) clearance for TITANIUM RETROGRADE FEMORAL NAIL - 13 M..., manufactured by Biomet Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013923 · Biomet Orthopedics, Inc. · Orthopedic device
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Feb 2002
Decision
90d
Days
Class 2
Risk

K013923 is an FDA 510(k) clearance for the TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Biomet Orthopedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 25, 2002 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 Biomet Orthopedics, Inc. devices

FDA 510(k) Submission Details - K013923

510(k) Number K013923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2001
Decision Date February 25, 2002
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.

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 365
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K013923.
S2 TIBIAL NAIL
K021027 · Howmedica Osteonics Corp. · Apr 2002
LONG LENGTH GAMMA NAIL
K020773 · Howmedica Osteonics Corp. · Apr 2002
GAMMA 3 LAG SCREW
K020677 · Howmedica Osteonics Corp. · Mar 2002
T2 FEMORAL NAIL SYSTEM
K014220 · Howmedica Osteonics Corp. · Jan 2002
LONG TROCHANTERIC NAIL SYSTEM
K013563 · DePuy Orthopaedics, Inc. · Dec 2001
POLARUS CAP SCREW
K013616 · Acu Med, Inc. · Dec 2001