Cleared Special

K041288 - MODIFICATION TO SMARTPIN

K041288 is an FDA 510(k) clearance for MODIFICATION TO SMARTPIN, manufactured by Linvatec Biomaterials, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Special 510(k) pathway after a 28-day FDA review.

K041288 · Linvatec Biomaterials, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
28d
Days
Class 2
Risk

K041288 is an FDA 510(k) clearance for the MODIFICATION TO SMARTPIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Linvatec Biomaterials, Inc. (Tampere, FI). The FDA issued a Cleared decision on June 10, 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 - K041288

510(k) Number K041288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2004
Decision Date June 10, 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.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 203
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K041288.
PINN-ACL CROSSPIN
K043106 · Linvatec Corp. · Jan 2005
MODIFICATION TO SMALL BONE FIXATION SYSTEM
K041157 · Hand Innovations, Inc. · Jul 2004
HUMERAL STAPLE
K041355 · Smith & Nephew, Inc. · Jul 2004
ARTHROTEK LACTONAIL
K040500 · Arthrotek, Inc. · May 2004
TRANSET FRACTURE FIXATION SYSTEM
K033717 · Bonutti Research, Inc. · Feb 2004
HANSSON PIN SYSTEM
K033968 · Howmedica Osteonics Corp. · Feb 2004
K041288 · MODIFICATION TO SMARTPIN
Download PDF FDA Summary Linvatec Biomaterials…