Cleared Special

K123501 - OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS

K123501 is an FDA 510(k) clearance for OSS MODULAR STEMS, 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 106-day FDA review.

K123501 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
106d
Days
Class 2
Risk

K123501 is an FDA 510(k) clearance for the OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS. 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 February 27, 2013 after a review of 106 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K123501

510(k) Number K123501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2012
Decision Date February 27, 2013
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
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 K123501.
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
METS MODULAR PROXIMAL FEMUR
K121056 · Stanmore Implants Worldwide , Ltd. · Sep 2012
METS MODULAR TOTAL FEMUR
K121055 · Stanmore Implants Worldwide , Ltd. · Sep 2012
SIGNATURE PLANNER,SIGNATURE GUIDES
K111863 · Materialise NV · Jun 2012
K123501 · OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS
Download PDF FDA Summary Biomet, Inc.