Cleared Traditional

K063588 - MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5

K063588 is an FDA 510(k) clearance for MATRYX INTERFERENCE SCREW, manufactured by Conmed Linvatec Biomaterials. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K063588 · Conmed Linvatec Biomaterials · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
92d
Days
Class 2
Risk

K063588 is an FDA 510(k) clearance for the MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,23113.... Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Conmed Linvatec Biomaterials (Tampere, FI). The FDA issued a Cleared decision on March 2, 2007 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Conmed Linvatec Biomaterials devices

FDA 510(k) Submission Details - K063588

510(k) Number K063588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2006
Decision Date March 02, 2007
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 804
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K063588.
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
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OSTEOMED HEADLESS CANNULATED SCREW SYSTEM
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VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810)
K063478 · Depuy Mitek, A Johnson & Johnson Company · Dec 2006
APERFIX TIBIAL IMPLANT WITH INSERTER
K063070 · Cayenne Medical, Inc. · Dec 2006
ARTHREX PUSHLOCK
K063479 · Arthrex, Inc. · Dec 2006