Cleared Traditional

SIRIUS FEMORAL STEM (K130610) - FDA 510(k) Clearance

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

K130610 · Biomet, Inc. · Orthopedic device
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Aug 2013
Decision
176d
Days
Class 2
Risk

K130610 is an FDA 510(k) clearance for the SIRIUS FEMORAL STEM. 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 August 30, 2013 after a review of 176 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

Submission Details

510(k) Number K130610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2013
Decision Date August 30, 2013
Days to Decision 176 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
54d slower than avg
Panel avg: 122d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K130610.
OSS/Arcos IM Total Femur Rod
K152621 · Biomet, Inc. · Oct 2015
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
K141331 · Biomet, Inc. · Oct 2014
Sirius Femoral Stem, Size 30A
K142295 · Biomet, Inc. · Sep 2014
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
K123598 · Smith & Nephew, Inc. · Jun 2013
OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS
K123501 · Biomet, Inc. · Feb 2013
EXETER HIP STEM
K110290 · Howmedica Osteonics Corp. · Sep 2011