Cleared Special

K100457 - OPUS SPEEDSCREW SYSTEM

K100457 is the FDA 510(k) clearance for OPUS SPEEDSCREW SYSTEM by Arthrocare Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 30-day FDA review.

K100457 · Arthrocare Corp. · Orthopedic device
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Mar 2010
Decision
30d
Days
Class 2
Risk

K100457 is an FDA 510(k) clearance for the OPUS SPEEDSCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrocare Corp. (Irvine, US). The FDA issued a Cleared decision on March 19, 2010 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arthrocare Corp. devices

Submission Details

510(k) Number K100457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2010
Decision Date March 19, 2010
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 552
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K100457.
DARCO HEADED CANNULATED SCREW
K100359 · Wrightmedicaltechnologyinc · Jun 2010
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K100325 · Smith & Nephew, Inc. · May 2010
OMNITECH LARGE, TRIMED COMPRESSION SCREW
K093676 · TriMed, Inc. · Mar 2010
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819
K100532 · Depuy Mitek, A Johnson & Johnson Company · Mar 2010
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
K092909 · Synthes (Usa) · Jan 2010