Cleared Special

K070507 - MODIFICATION TO: LIGAFIX INTERFERENCE SCREW

K070507 is an FDA 510(k) clearance for MODIFICATION TO: LIGAFIX INTERFERENCE SCREW, manufactured by Science For Biomaterials. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 36-day FDA review.

K070507 · Science For Biomaterials · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
36d
Days
Class 2
Risk

K070507 is an FDA 510(k) clearance for the MODIFICATION TO: LIGAFIX INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Science For Biomaterials (Lourdes, FR). The FDA issued a Cleared decision on March 29, 2007 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 - K070507

510(k) Number K070507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2007
Decision Date March 29, 2007
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 1052
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K070507.
METASURG SUBTALAR IMPLANT
K070441 · Metasurg · May 2007
LAGWIRE SYSTEM
K070393 · Fxdevices · May 2007
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
K070906 · Zimmer, Inc. · May 2007
CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER
K070525 · Wrightmedicaltechnologyinc · Mar 2007
MEMOMETAL FIXOS SCREWS
K070039 · Memometal Technologies · Mar 2007
UNITY ALPHA SYSTEM
K062820 · Bonutti Research, Inc. · Mar 2007
K070507 · MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
Download PDF FDA Summary Science For Biomateri…