Cleared Special

TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 (K012280) - FDA 510(k) Clearance

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

K012280 · Triage Medical, Inc. · Orthopedic device
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Aug 2001
Decision
29d
Days
Class 2
Risk

K012280 is an FDA 510(k) clearance for the TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Triage Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on August 17, 2001 after a review of 29 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 Triage Medical, Inc. devices

Submission Details

510(k) Number K012280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2001
Decision Date August 17, 2001
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
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 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K012280.
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · Synthes (Usa) · Dec 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · Synthes (Usa) · Dec 2001
INTEX SCREW
K012798 · Biomet, Inc. · Nov 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102 · Aesculap, Inc. · Aug 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · Arthrex, Inc. · May 2001
LACTOSORB 5.0 MM WASHER
K001581 · Biomet, Inc. · Mar 2001