Cleared Traditional

K062260 - OSTEOBOOST-BMA

K062260 is an FDA 510(k) clearance for OSTEOBOOST-BMA, manufactured by Orthos Limited. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K062260 · Orthos Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
83d
Days
Class 2
Risk

K062260 is an FDA 510(k) clearance for the OSTEOBOOST-BMA. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Orthos Limited (Bristol, North Somerset, GB). The FDA issued a Cleared decision on October 26, 2006 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 Orthos Limited devices

FDA 510(k) Submission Details - K062260

510(k) Number K062260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2006
Decision Date October 26, 2006
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 410
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K062260.
MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE
K063613 · Terumo Medical Corp. · Dec 2006
MEDTRONIC GRAFT DELIVERY SYRINGE
K062986 · Medtronic Sofamor Danek USA, Inc. · Dec 2006
INJEKT SYRINGE
K063280 · B.Braun Medical, Inc. · Nov 2006
ARTHREX ASPIRATE KIT
K062365 · Arthrex, Inc. · Sep 2006
BAXTER DUPLOSPRAY MIS APPLICATOR
K061092 · Micromedics, Inc. · Sep 2006
MODIFICATION TO BONE GRAFT SYRINGE
K062173 · Wrightmedicaltechnologyinc · Aug 2006