Cleared Special

Sirius Femoral Stem, Size 30A (K142295) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K142295 · Biomet, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 2014
Decision
28d
Days
Class 2
Risk

K142295 is an FDA 510(k) clearance for the Sirius Femoral Stem, Size 30A. 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 September 15, 2014 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet, Inc. devices

Submission Details

510(k) Number K142295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2014
Decision Date September 15, 2014
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 275
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K142295.
REDAPT Anteverted Cemented Liner
K160923 · Smith & Nephew, Inc. · Nov 2016
OSS/Arcos IM Total Femur Rod
K152621 · Biomet, Inc. · Oct 2015
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
K141331 · Biomet, Inc. · Oct 2014
SIRIUS FEMORAL STEM
K130610 · Biomet, Inc. · Aug 2013
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
K123598 · Smith & Nephew, Inc. · Jun 2013
OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS
K123501 · Biomet, Inc. · Feb 2013