Cleared Special

K042244 - BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE

K042244 is an FDA 510(k) clearance for BONE-LOK MVP CORTICAL-CANCELLOUS COMPRE..., manufactured by Triage Medical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 28-day FDA review.

K042244 · Triage Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
28d
Days
Class 2
Risk

K042244 is an FDA 510(k) clearance for the BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE. 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 September 16, 2004 after a review of 28 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 - K042244

510(k) Number K042244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2004
Decision Date September 16, 2004
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 1063
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K042244.
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
K042356 · Synthes (Usa) · Oct 2004
ENDOTINE MIDFACE B 4.5 DEVICE
K041835 · Coapt Systems, Inc. · Sep 2004
HYPROCURE SUBTALAR IMPLANT SYSTEM
K042030 · Graham Medical Technologies, LLC · Sep 2004
SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
K042295 · Linvatec Biomaterials, Ltd. · Sep 2004
ORTHO-PRO CANNULATED BONE SCREWS
K042310 · Ortho-Pro, LLC · Sep 2004
SCANDIUS ACL RECONSTRUCTION SYSTEM
K041749 · Scandius Biomedical, Inc. · Sep 2004
K042244 · BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
Download PDF FDA Summary Triage Medical, Inc.