Cleared Traditional

K071476 - SYNTHES (USA) 2ND GENERATION PELVIC C-C...

K071476 is the FDA 510(k) clearance for SYNTHES (USA) 2ND GENERATION PELVIC C-C... by Synthes (Usa). It is a Class 2 Orthopedic device (product code JEC) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K071476 · Synthes (Usa) · Orthopedic device
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Aug 2007
Decision
87d
Days
Class 2
Risk

K071476 is an FDA 510(k) clearance for the SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on August 24, 2007 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 K071476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2007
Decision Date August 24, 2007
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEC Component, Traction, Invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JEC Component, Traction, Invasive

All 43
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