Cleared Traditional

K050407 - LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60

K050407 is an FDA 510(k) clearance for LIGAFIX RESORBABLE INTERFERENCE SCREW, manufactured by Sciences For Bio Materials. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K050407 · Sciences For Bio Materials · Orthopedic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K050407

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.

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 811
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K050407.
NEXA BONE SCREW SYSTEM
K053394 · Nexa Orthopedics, Inc. · Dec 2005
KALIX II IMPLANT, MODEL 141 0XX WITH XX
K053093 · New Deal, S.A. · Dec 2005
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
K052607 · Arthrex, Inc. · Nov 2005
ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
K052630 · Depuy Mitek, A Johnson & Johnson Company · Oct 2005
ARTHREX TENODESIS FAMILY
K051726 · Arthrex, Inc. · Sep 2005
MBARESORB IMPLANT
K051611 · Kinetikos Medical, Inc. · Sep 2005