Cleared Traditional

K992063 - OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY

K992063 is an FDA 510(k) clearance for OSTEO IC FEMORAL AND TIBIAL NAILS IN TI..., manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K992063

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.

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 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K992063.
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
PYLON INTRAMEDULLAARY NAIL SYSTEM
K992350 · Alphatec Mfg., Inc. · Sep 1999
ULTIMAX ANKLE FUSION ROD SYSTEM
K991790 · Encore Orthopedics, Inc. · Aug 1999
FIXION INTRAMEDULLARY NAILING SYSTEM
K990717 · Disco-O-Tech Medical Technologies, Ltd. · Jun 1999
PERRY HUMERAL NAIL
K990322 · Pioneer Surgical Technology · Apr 1999