Cleared Traditional

K992063 - OSTEO IC FEMORAL AND TIBIAL NAILS IN TI...

K992063 is the FDA 510(k) clearance for OSTEO IC FEMORAL AND TIBIAL NAILS IN TI... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K992063 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
77d
Days
Class 2
Risk

K992063 is an FDA 510(k) clearance for the OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 77 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 Osteonics Corp. devices

Submission Details

510(k) Number K992063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1999
Decision Date September 03, 1999
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 328
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K992063.
TITANIUM PEDIATRIC FEMORAL NAIL
K993956 · Biomet, Inc. · Dec 1999
WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW
K993603 · Howmedica Osteonics Corp. · Nov 1999
MODIFIED LONG LENGTH GAMMA NAIL
K993670 · Howmedica Osteonics Corp. · Nov 1999
ULTIMAX ANKLE FUSION ROD SYSTEM
K991790 · Encore Orthopedics, Inc. · Aug 1999
PERRY HUMERAL NAIL
K990322 · Pioneer Surgical Technology · Apr 1999
OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER
K990152 · Howmedica Osteonics Corp. · Mar 1999