Cleared Special

K122228 - LIGAFIX INTERFERENCE SCREW

K122228 is an FDA 510(k) clearance for LIGAFIX INTERFERENCE SCREW, manufactured by Sbm Sciences For Bio Materials. The device is a Class 2 Orthopedic device with product code MAI cleared through the Special 510(k) pathway after a 69-day FDA review.

K122228 · Sbm Sciences For Bio Materials · Orthopedic device
Download Printable Device Report (PDF)
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Oct 2012
Decision
69d
Days
Class 2
Risk

K122228 is an FDA 510(k) clearance for the LIGAFIX INTERFERENCE SCREW. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Sbm Sciences For Bio Materials (Lourdes, FR). The FDA issued a Cleared decision on October 3, 2012 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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.

View all Sbm Sciences For Bio Materials devices

FDA 510(k) Submission Details - K122228

510(k) Number K122228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2012
Decision Date October 03, 2012
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 209
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K122228.
TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
K122635 · Tornier, Inc. · May 2013
HEALICOIL SUTURE ANCHOR WITH REGENESORB
K123393 · Smith & Nephew, Inc. · Apr 2013
MILAGRO INTERFERENCE SCREWS
K122869 · Depuy Mitek, A Johnson & Johnson Company · Dec 2012
GENESYS PRESSFT SUTURE ANCHOR
K121890 · Linvatec Corporation D/B/A Conmed Linvatec · Aug 2012
MILAGRO INTERFERENCE SCREWS
K120589 · Depuy Mitek, A Johnson & Johnson Company · Apr 2012
BIOBOLT
K120540 · Arthrex, Inc. · Mar 2012