Cleared Traditional

K024199 - IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP

K024199 is an FDA 510(k) clearance for IMMIX THIN FILM, manufactured by Osteobiologics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K024199 · Osteobiologics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
84d
Days
Class 2
Risk

K024199 is an FDA 510(k) clearance for the IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-00.... Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Osteobiologics, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 14, 2003 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osteobiologics, Inc. devices

FDA 510(k) Submission Details - K024199

510(k) Number K024199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2002
Decision Date March 14, 2003
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 241
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K024199.
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ORTHOMEND
K031188 · Tei Biosciences, Inc. · Jun 2003
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K030631 · Prosurg, Inc. · May 2003
V.A.C. ABDOMINAL DRESSING
K022011 · Kinetic Concepts, Inc. · Feb 2003
SMALL BARD VENTRALEX PATCH
K024008 · C.R. Bard, Inc. · Feb 2003
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
K021835 · Brennen Medical, Inc. · Oct 2002