Cleared Traditional

K012817 - HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED

K012817 is an FDA 510(k) clearance for HELICAL COMPRESSION ANCHOR SYSTEM, manufactured by Triage Medical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K012817 · Triage Medical, Inc. · Orthopedic device
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Nov 2001
Decision
90d
Days
Class 2
Risk

K012817 is an FDA 510(k) clearance for the HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED. 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 November 20, 2001 after a review of 90 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. 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 Triage Medical, Inc. devices

FDA 510(k) Submission Details - K012817

510(k) Number K012817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2001
Decision Date November 20, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
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 807
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K012817.
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · Synthes (Usa) · Dec 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · Synthes (Usa) · Dec 2001
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
K013546 · Bionx Implants, Inc. · Nov 2001
RESORBABLE SCREW ANCHOR
K012872 · Arthrotek, Inc. · Nov 2001
INTEX SCREW
K012798 · Biomet, Inc. · Nov 2001
MODIFICATION TO THE I.C.O.S SCREW
K011821 · New Deal, S.A. · Sep 2001