Cleared Traditional

LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 (K050407) - FDA 510(k) Clearance

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

K050407 · Sciences For Bio Materials · Orthopedic device
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Nov 2005
Decision
260d
Days
Class 2
Risk

K050407 is an FDA 510(k) clearance for the LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Sciences For Bio Materials (Lourdes, FR). The FDA issued a Cleared decision on November 4, 2005 after a review of 260 days - an extended review cycle.

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 Sciences For Bio Materials devices

Submission Details

510(k) Number K050407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2005
Decision Date November 04, 2005
Days to Decision 260 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
138d slower than avg
Panel avg: 122d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K050407.
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K053338 · Arthrex, Inc. · Jan 2006
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K053136 · Wrightmedicaltechnologyinc · Jan 2006
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
K052607 · Arthrex, Inc. · Nov 2005
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K051726 · Arthrex, Inc. · Sep 2005
PLC SCREW
K051310 · Smith & Nephew, Inc. · Jul 2005
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K051098 · Zimmer, Inc. · Jul 2005