Cleared Special

K022647 - HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM

K022647 is an FDA 510(k) clearance for HELICAL COMPRESSION ANCHOR SYSTEM, manufactured by Triad Medical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 27-day FDA review.

K022647 · Triad Medical, Inc. · Orthopedic device
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Sep 2002
Decision
27d
Days
Class 2
Risk

K022647 is an FDA 510(k) clearance for the HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Triad Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on September 5, 2002 after a review of 27 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.

FDA 510(k) Submission Details - K022647

510(k) Number K022647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2002
Decision Date September 05, 2002
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K022647.
INION CPS 2.5/2.8 SCREW
K022981 · Inion , Ltd. · Sep 2002
SYNTHES 6.5 MM CANNULATED SCREW
K021932 · Synthes (Usa) · Sep 2002
STAYFUSE GT-IP
K022726 · Pioneer Surgical Technology · Sep 2002
MAGLY 6.5MM CANNULATED SCREWS
K021662 · Magly Orthopedics, LLC · Aug 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
K021556 · Synthes (Usa) · Aug 2002
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM
K021579 · Magly Orthopedics, LLC · Aug 2002
K022647 · HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM
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