Cleared Traditional

PERI-PROSTHETIC CABLE SYSTEM (K133354) - FDA 510(k) Clearance

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

K133354 · Biomet, Inc. · Orthopedic device
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Jan 2014
Decision
88d
Days
Class 2
Risk

K133354 is an FDA 510(k) clearance for the PERI-PROSTHETIC CABLE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 27, 2014 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 Biomet, Inc. devices

Submission Details

510(k) Number K133354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2013
Decision Date January 27, 2014
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 49
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K133354.
Arthrex FiberTape Cerclage
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Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
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Suture Wires and Wire Loops
K150889 · Zimmer, Inc. · Jul 2015
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · Synthes (Usa) · Jul 2011
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
K081205 · Synthes (Usa) · Jul 2008
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
K063017 · Aesculap, Inc. · Dec 2006