Cleared Traditional

BIO 1-KIT BIOSORB FILLED CARTRIDGE (K061022) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K061022 · Science For Biomaterials · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
41d
Days
Class 2
Risk

K061022 is an FDA 510(k) clearance for the BIO 1-KIT BIOSORB FILLED CARTRIDGE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Science For Biomaterials (Lourdes, FR). The FDA issued a Cleared decision on May 24, 2006 after a review of 41 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.

View all Science For Biomaterials devices

Submission Details

510(k) Number K061022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2006
Decision Date May 24, 2006
Days to Decision 41 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 122d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 195
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K061022.
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
K072597 · Wrightmedicaltechnologyinc · Oct 2007
PRO-DENSE BONE VOID FILLER
K070437 · Wrightmedicaltechnologyinc · May 2007
MODIFICATION TO ALLOMATRIX CUSTOM
K061939 · Wrightmedicaltechnologyinc · Jul 2006
NORIAN SRS BONE VOID FILLER
K060408 · Synthes (Usa) · Mar 2006
NORIAN SRS FAST SET PUTTY
K060406 · Synthes (Usa) · Mar 2006
ALLOMATRIX CUSTOM
K053319 · Wrightmedicaltechnologyinc · Mar 2006