Cleared Traditional

POLYGRAFT BGS (K041382) - FDA 510(k) Clearance

Also marketed or referenced as:
BONE GRAFT SUBSTITUTE

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

K041382 · Osteobiologics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2005
Decision
388d
Days
Class 2
Risk

K041382 is an FDA 510(k) clearance for the POLYGRAFT BGS. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Osteobiologics, Inc. (San Antonio, US). The FDA issued a Cleared decision on June 17, 2005 after a review of 388 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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. Elevated predicate reliance profile. 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 Osteobiologics, Inc. devices

Submission Details

510(k) Number K041382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received May 25, 2004
Decision Date June 17, 2005
Days to Decision 388 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
266d slower than avg
Panel avg: 122d · This submission: 388d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDK Prosthesis, Hip, Cement Restrictor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - JDK Prosthesis, Hip, Cement Restrictor

All 12
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K041382.
Mectaplug PE II
K210062 · Medacta International S.A. · Apr 2021
CEMENT RESTRICTOR, SMALL AND LARGE
K021765 · Exactech, Inc. · Aug 2002
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · Medtronic Sofamor Danek USA, Inc. · Oct 2001
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443 · Medtronic Sofamor Danek USA, Inc. · Aug 2001
OSTEONICS SCREW HOLE PLUGS
K965056 · Osteonics Corp. · Feb 1997
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
K923616 · Osteonics Corp. · Oct 1992