Cleared Special

MAXTORQUE MINI CANNULATED SCREW SYSTEM (K082574) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K082574 · Orthohelix Surgical Designs, Inc. · Orthopedic device
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Dec 2008
Decision
94d
Days
Class 2
Risk

K082574 is an FDA 510(k) clearance for the MAXTORQUE MINI CANNULATED SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Orthohelix Surgical Designs, Inc. (Akron, US). The FDA issued a Cleared decision on December 8, 2008 after a review of 94 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orthohelix Surgical Designs, Inc. devices

Submission Details

510(k) Number K082574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2008
Decision Date December 08, 2008
Days to Decision 94 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 122d · This submission: 94d
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 402
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K082574.
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
K092909 · Synthes (Usa) · Jan 2010
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
K090949 · Synthes (Usa) · Jul 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656 · Smith & Nephew, Inc. · 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