Cleared Traditional

K081011 - AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45

K081011 is an FDA 510(k) clearance for AREX SCRU 2 HEADLESS COMPRESSION SCREWS, manufactured by Arex USA. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K081011 · Arex USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K081011

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.

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 776
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K081011.
APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM
K083612 · Cayenne Medical, Inc. · Mar 2009
MAXTORQUE MINI CANNULATED SCREW SYSTEM
K082574 · Orthohelix Surgical Designs, Inc. · Dec 2008
ORTHOPEDIATRICS BONE SCREWS
K082949 · OrthoPediatrics Corp. · Nov 2008
DARCO SMALL SCREW
K082320 · Wrightmedicaltechnologyinc · Nov 2008
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
K081893 · Arthrocare Corp. · Oct 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516 · Smith & Nephew, Inc. · Sep 2008