Cleared Special

K041889 - TRI-OSTETIC

K041889 is an FDA 510(k) clearance for TRI-OSTETIC, manufactured by Berkeley Advanced Biomaterials, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 38-day FDA review.

K041889 · Berkeley Advanced Biomaterials, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
38d
Days
Class 2
Risk

K041889 is an FDA 510(k) clearance for the TRI-OSTETIC. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Berkeley Advanced Biomaterials, Inc. (San Leandro, US). The FDA issued a Cleared decision on August 19, 2004 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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. Low regulatory complexity profile. 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 - K041889

510(k) Number K041889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2004
Decision Date August 19, 2004
Days to Decision 38 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
84d faster than avg
Panel avg: 122d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

MQV Device Classification - Class 2, Special Controls

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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K041889.
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
K041613 · Novabone Products, LLC · Aug 2004
BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID
K041616 · Orthos (Uk) Limited · Aug 2004
CEMENTEK
K041493 · Teknimed, S.A. · Aug 2004
POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX
K033707 · Osteobiologics, Inc. · Aug 2004
PORE-SI BONE GRAFT SUBSTITUTE
K040082 · Apatech , Ltd. · Aug 2004
ALLOMATRIX PUTTY
K041168 · Wrightmedicaltechnologyinc · Aug 2004
K041889 · TRI-OSTETIC
Download PDF FDA Summary Berkeley Advanced Bio…