Cleared Traditional

K050468 - TRIABSORB COMPOSITE SCREW

K050468 is an FDA 510(k) clearance for TRIABSORB COMPOSITE SCREW, manufactured by Advanced Biomaterials. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K050468 · Advanced Biomaterials · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
189d
Days
Class 2
Risk

K050468 is an FDA 510(k) clearance for the TRIABSORB COMPOSITE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Advanced Biomaterials (St. Jeannet, FR). The FDA issued a Cleared decision on August 31, 2005 after a review of 189 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.

FDA 510(k) Submission Details - K050468

510(k) Number K050468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2005
Decision Date August 31, 2005
Days to Decision 189 days
Submission Type Traditional
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
67d slower than avg
Panel avg: 122d · This submission: 189d
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 1065
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K050468.
ARTHREX TENODESIS FAMILY
K051726 · Arthrex, Inc. · Sep 2005
REFIX INTERNAL FRACTURE FIXATION SCREWS
K050388 · Xtremi-T, LLC · Sep 2005
MBARESORB IMPLANT
K051611 · Kinetikos Medical, Inc. · Sep 2005
MATRYX INTERFERENCE SCREW
K052080 · Linvatec Biomaterials, Inc. · Aug 2005
PLC SCREW
K051310 · Smith & Nephew, Inc. · Jul 2005
ROI FUSION RODS & PLATES
K051309 · Reiley Orthopaedics, Inc. · Jul 2005
K050468 · TRIABSORB COMPOSITE SCREW
Download PDF FDA Summary Advanced Biomaterials