Cleared Traditional

K043176 - ARC SURGICAL RESORBABLE COMPRESSION SCR...

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)
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.

View all Arc Surgical, LLC devices

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
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 742
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K043176.
PLC SCREW
K051310 · Smith & Nephew, 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
MERETE DUOTHREADTM BONE SCREW
K050924 · Merete Medical GmbH · May 2005
ARTHREX TAK FAMILY
K050749 · Arthrex, Inc. · May 2005
SYNTHES (USA) 3.5MM CONICAL SCREWS
K050683 · Synthes (Usa) · Apr 2005