Cleared Traditional

K041616 - BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID

K041616 is an FDA 510(k) clearance for BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID, manufactured by Orthos (Uk) Limited. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K041616 · Orthos (Uk) Limited · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
71d
Days
Class 2
Risk

K041616 is an FDA 510(k) clearance for the BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Orthos (Uk) Limited (Bristol North Somerset, GB). The FDA issued a Cleared decision on August 25, 2004 after a review of 71 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. 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.

FDA 510(k) Submission Details - K041616

510(k) Number K041616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2004
Decision Date August 25, 2004
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K041616.
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
K041089 · Biomet Manufacturing, Inc. · Aug 2004
NAME BONE VOID FILLER
K041421 · Stryker Biotech · Aug 2004
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
K041613 · Novabone Products, LLC · Aug 2004
CEMENTEK
K041493 · Teknimed, S.A. · Aug 2004
TRI-OSTETIC
K041889 · Berkeley Advanced Biomaterials, Inc. · 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
K041616 · BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID
Download PDF FDA Summary Orthos (Uk) Limited