Cleared Traditional

K043176 - ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM

K043176 is an FDA 510(k) clearance for ARC SURGICAL RESORBABLE COMPRESSION SCR..., manufactured by Arc Surgical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K043176 · Arc Surgical, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K043176

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
Combination Product No
PCCP Authorized No
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.

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 1052
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K043176.
ROI FUSION RODS & PLATES
K051309 · Reiley Orthopaedics, Inc. · Jul 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
K051098 · Zimmer, Inc. · Jul 2005
MERETE TWISTCUT SNAP-OFF BONE SCREW
K051323 · Merete Medical GmbH · Jul 2005
STERLING INTERFERENCE SCREW ST
K050767 · Regeneration Technologies, Inc. · Jun 2005
MERETE DUOTHREADTM BONE SCREW
K050924 · Merete Medical GmbH · May 2005
PRECIMED CANNULATED SCREW SYSTEM
K050754 · Precimed, Inc. · May 2005
K043176 · ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM
Download PDF FDA Summary Arc Surgical, LLC