Cleared Traditional

K050938 - KNEE FUSION NAIL

K050938 is the FDA 510(k) clearance for KNEE FUSION NAIL by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code JDS) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K050938 · Smith & Nephew, Inc. · Orthopedic device
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May 2005
Decision
20d
Days
Class 2
Risk

K050938 is an FDA 510(k) clearance for the KNEE FUSION NAIL. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on May 4, 2005 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K050938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2005
Decision Date May 04, 2005
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDS Nail, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDS Nail, Fixation, Bone

All 37
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K050938.
KNEE FUSION NAIL
K061783 · Smith & Nephew, Inc. · Aug 2006
TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
K061019 · Smith & Nephew, Inc. · Jun 2006
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS
K051557 · Smith & Nephew, Inc. · Jun 2005
SYNTHES (USA) TIBIAL NAIL SYSTEM EX
K040762 · Synthes (Usa) · Apr 2004
TRIGEN INTERTAN
K040212 · Smith & Nephew, Inc. · Feb 2004
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
K033071 · Synthes (Usa) · Nov 2003