Cleared Traditional

K040762 - SYNTHES (USA) TIBIAL NAIL SYSTEM EX (FDA 510(k) Clearance)

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

K040762 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
18d
Days
Class 2
Risk

K040762 is an FDA 510(k) clearance for the SYNTHES (USA) TIBIAL NAIL SYSTEM EX. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on April 12, 2004 after a review of 18 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 Synthes (Usa) devices

Submission Details

510(k) Number K040762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2004
Decision Date April 12, 2004
Days to Decision 18 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 122d · This submission: 18d
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 52
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K040762.
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