Cleared Traditional

AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 (K081011) - FDA 510(k) Clearance

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

K081011 · Arex USA · Orthopedic device
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Nov 2008
Decision
212d
Days
Class 2
Risk

K081011 is an FDA 510(k) clearance for the AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, .... Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arex USA (Collegeville, US). The FDA issued a Cleared decision on November 7, 2008 after a review of 212 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 Arex USA devices

Submission Details

510(k) Number K081011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2008
Decision Date November 07, 2008
Days to Decision 212 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
90d slower than avg
Panel avg: 122d · This submission: 212d
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 K081011.
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
K090949 · Synthes (Usa) · Jul 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656 · Smith & Nephew, Inc. · Jun 2009
MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT
K091069 · Medacta International S.A. · Jun 2009
DARCO SMALL SCREW
K082320 · Wrightmedicaltechnologyinc · Nov 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516 · Smith & Nephew, Inc. · Sep 2008
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700 · Synthes (Usa) · Jul 2008