Cleared Traditional

ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM (K043176) - FDA 510(k) Clearance

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

K043176 · Arc Surgical, LLC · Orthopedic device
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Jun 2005
Decision
213d
Days
Class 2
Risk

K043176 is an FDA 510(k) clearance for the ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arc Surgical, LLC (Hillsboro, US). The FDA issued a Cleared decision on June 17, 2005 after a review of 213 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 Arc Surgical, LLC devices

Submission Details

510(k) Number K043176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2004
Decision Date June 17, 2005
Days to Decision 213 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
91d slower than avg
Panel avg: 122d · This submission: 213d
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 K043176.
ARTHREX TENODESIS FAMILY
K051726 · Arthrex, Inc. · Sep 2005
PLC SCREW
K051310 · Smith & Nephew, Inc. · Jul 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
K051098 · Zimmer, Inc. · Jul 2005
ARTHREX TAK FAMILY
K050749 · Arthrex, Inc. · May 2005
SYNTHES (USA) 3.5MM CONICAL SCREWS
K050683 · Synthes (Usa) · Apr 2005
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
K050636 · Synthes (Usa) · Apr 2005