Cleared Traditional

K102992 - T2 RECON NAIL

K102992 is the FDA 510(k) clearance for T2 RECON NAIL by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K102992 · Howmedica Osteonics Corp. · Orthopedic device
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Dec 2010
Decision
75d
Days
Class 2
Risk

K102992 is an FDA 510(k) clearance for the T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 75 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 K102992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2010
Decision Date December 22, 2010
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
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 323
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K102992.
UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
K111444 · DePuy Orthopaedics, Inc. · Jun 2011
VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW
K110552 · Wrightmedicaltechnologyinc · Mar 2011
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
K103002 · Synthes (Usa) · Mar 2011
ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS
K101622 · Zimmer, Inc. · Oct 2010
T2 GREATER TROCHANTER NAIL
K101438 · Howmedica Osteonics Corp. · Jun 2010
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
K100238 · DePuy Orthopaedics, Inc. · May 2010