Cleared Special

K101557 - GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN

K101557 is an FDA 510(k) clearance for GAMMA-BSM, manufactured by Etex Corp.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 27-day FDA review.

K101557 · Etex Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
27d
Days
Class 2
Risk

K101557 is an FDA 510(k) clearance for the GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Etex Corp. (Cambridge, US). The FDA issued a Cleared decision on July 1, 2010 after a review of 27 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 - K101557

510(k) Number K101557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2010
Decision Date July 01, 2010
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 K101557.
BONEOPTIMIZER
K100841 · Curasan AG · Aug 2010
BIOGENNIX RPC
K093342 · Biogennix, LLC · Jul 2010
CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION
K100986 · Skeletal Kinetics, LLC · Jul 2010
B-GENIN AND R-GENIN
K091912 · Berkeley Advanced Biomaterials, Inc. · Jun 2010
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K092608 · Collagen Matrix, Inc. · May 2010
GRAFTY QUICKSET
K093343 · Graftys · Apr 2010