Cleared Traditional

OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM (K041089) - FDA 510(k) Clearance

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

K041089 · Biomet Manufacturing, Inc. · Orthopedic device
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Aug 2004
Decision
127d
Days
Class 2
Risk

K041089 is an FDA 510(k) clearance for the OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 31, 2004 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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 Manufacturing, Inc. devices

Submission Details

510(k) Number K041089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2004
Decision Date August 31, 2004
Days to Decision 127 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 122d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 - MQV Filler, Bone Void, Calcium Compound

All 201
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K041089.
IGNITE BONE VOID FILLER KIT
K052913 · Wrightmedicaltechnologyinc · Nov 2005
SYNTHES (USA) CHRONOS
K043045 · Synthes (Usa) · Jan 2005
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663 · Wrightmedicaltechnologyinc · Sep 2004
ALLOMATRIX PUTTY
K041168 · Wrightmedicaltechnologyinc · Aug 2004
NORIAN SRS FAST SET PUTTY
K041842 · Synthes (Usa) · Jul 2004
ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T
K040980 · Wrightmedicaltechnologyinc · Jul 2004