Cleared Traditional

K141331 - BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)

K141331 is an FDA 510(k) clearance for BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS), manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K141331 · Biomet, Inc. · Orthopedic device
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Oct 2014
Decision
159d
Days
Class 2
Risk

K141331 is an FDA 510(k) clearance for the BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS). Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 27, 2014 after a review of 159 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet, Inc. devices

FDA 510(k) Submission Details - K141331

510(k) Number K141331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2014
Decision Date October 27, 2014
Days to Decision 159 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
37d slower than avg
Panel avg: 122d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 515
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K141331.
OSS/Arcos IM Total Femur Rod
K152621 · Biomet, Inc. · Oct 2015
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
K142814 · Biomet Manufacturing, LLC · Jun 2015
Corin TaperFit Hip Stem
K142761 · Corin USA · Apr 2015
Sirius Femoral Stem, Size 30A
K142295 · Biomet, Inc. · Sep 2014
RENOVIS CEMENTED HIP SYSTEM
K141370 · Renovis Surgical Technologies, Inc. · Sep 2014
SIRIUS FEMORAL STEM
K130610 · Biomet, Inc. · Aug 2013