Cleared Traditional

OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL (K982601) - FDA 510(k) Clearance

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

K982601 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
49d
Days
Class 2
Risk

K982601 is an FDA 510(k) clearance for the OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on September 14, 1998 after a review of 49 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 Osteonics Corp. devices

Submission Details

510(k) Number K982601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1998
Decision Date September 14, 1998
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 256
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K982601.
OSTEO DYNATROC PROXIMAL FEMORAL NAIL
K983339 · Osteonics Corp. · Oct 1998
ZETA MULTIZONE SCN LOCKING NAIL
K982873 · Howmedica Corp. · Oct 1998
TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES
K982953 · Biomet, Inc. · Oct 1998
RETROGRADE ROD SYSTEM
K982602 · Howmedica Corp. · Sep 1998
HOWMEDICA SCN NAIL
K981261 · Howmedica Corp. · Jun 1998
OSTEO I-C HUMERAL NAIL SYSTEM
K981309 · Osteonics Corp. · Jun 1998