Cleared Special

K142295 - Sirius Femoral Stem, Size 30A

K142295 is an FDA 510(k) clearance for Sirius Femoral Stem, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Special 510(k) pathway after a 28-day FDA review.

K142295 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K142295

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.

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 564
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K142295.
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
K142814 · Biomet Manufacturing, LLC · Jun 2015
Corin TaperFit Hip Stem
K142761 · Corin USA · Apr 2015
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
K141331 · Biomet, Inc. · Oct 2014
RENOVIS CEMENTED HIP SYSTEM
K141370 · Renovis Surgical Technologies, Inc. · Sep 2014
SIRIUS FEMORAL STEM
K130610 · Biomet, Inc. · Aug 2013
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
K123598 · Smith & Nephew, Inc. · Jun 2013
K142295 · Sirius Femoral Stem, Size 30A
Download PDF FDA Summary Biomet, Inc.