Cleared Special

K042295 - SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020

K042295 is an FDA 510(k) clearance for SMARTSCREW II, manufactured by Linvatec Biomaterials, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 23-day FDA review.

K042295 · Linvatec Biomaterials, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
23d
Days
Class 2
Risk

K042295 is an FDA 510(k) clearance for the SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Linvatec Biomaterials, Ltd. (Tampere, FI). The FDA issued a Cleared decision on September 16, 2004 after a review of 23 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 - K042295

510(k) Number K042295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2004
Decision Date September 16, 2004
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
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 1065
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K042295.
ENDOTINE MIDFACE B 4.5 DEVICE
K041835 · Coapt Systems, Inc. · Sep 2004
HYPROCURE SUBTALAR IMPLANT SYSTEM
K042030 · Graham Medical Technologies, LLC · Sep 2004
BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
K042244 · Triage Medical, Inc. · Sep 2004
ORTHO-PRO CANNULATED BONE SCREWS
K042310 · Ortho-Pro, LLC · Sep 2004
SCANDIUS ACL RECONSTRUCTION SYSTEM
K041749 · Scandius Biomedical, Inc. · Sep 2004
BIOPRO SUBTALAR IMPLANT
K041936 · Biopro, Inc. · Sep 2004
K042295 · SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
Download PDF FDA Summary Linvatec Biomaterials…