Cleared Traditional

K972813 - GAMMA LOCKING NAIL SYSTEM

K972813 is the FDA 510(k) clearance for GAMMA LOCKING NAIL SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K972813 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
72d
Days
Class 2
Risk

K972813 is an FDA 510(k) clearance for the GAMMA LOCKING NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on October 9, 1997 after a review of 72 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 Howmedica Corp. devices

Submission Details

510(k) Number K972813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1997
Decision Date October 09, 1997
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 K972813.
HOWMEDICA(R) FULLY THREADED SCREWS
K974720 · Howmedica, Inc. · Mar 1998
DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL
K974781 · Depuy, Inc. · Mar 1998
ORTHOFIX FEMORAL NAILING SYTEM
K973944 · Orthofix Srl · Dec 1997
HOWMEDICA FULLY THREADED SCREWS
K972811 · Howmedica Corp. · Oct 1997
MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION
K971056 · Wrightmedicaltechnologyinc · Oct 1997
MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL
K972692 · Zimmer, Inc. · Sep 1997