Cleared Traditional

K041382 - POLYGRAFT BGS

Also marketed or referenced as:
BONE GRAFT SUBSTITUTE

K041382 is an FDA 510(k) clearance for POLYGRAFT BGS, manufactured by Osteobiologics, Inc.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 388-day FDA review.

K041382 · Osteobiologics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K041382

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
Combination Product No
PCCP Authorized No
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.

JDK Device Classification - Class 2, Special Controls

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 52
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K041382.
SKELITE RESORBABLE CEMENT RESTRICTOR
K051836 · Millenium Biologix, Inc. · Nov 2005
NOVASPINE CEMENT RESTRICTOR NSCR
K051607 · Novaspine, LLC · Oct 2005
SCIENT'X CEMENT RESTRICTOR
K052367 · Scient'X · Oct 2005
MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
K050699 · Amedica Corp. · Apr 2005
PEEK CEMENT RESTRICTOR X-BOX
K041583 · Innovasis, Inc. · Jul 2004
OPTIMESH 500E CEMENT RESTRICTOR
K033953 · Spineology, Inc. · Jul 2004
K041382 · POLYGRAFT BGS
Download PDF FDA Summary Osteobiologics, Inc.