Cleared Traditional

K910128 - LEVTECH TITANIUM BONE WIRE

K910128 is an FDA 510(k) clearance for LEVTECH TITANIUM BONE WIRE, manufactured by Levtech, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K910128 · Levtech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
160d
Days
Class 2
Risk

K910128 is an FDA 510(k) clearance for the LEVTECH TITANIUM BONE WIRE. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Levtech, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 18, 1991 after a review of 160 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 Levtech, Inc. devices

FDA 510(k) Submission Details - K910128

510(k) Number K910128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1991
Decision Date June 18, 1991
Days to Decision 160 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 122d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 112
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K910128.
DEPUY (NITINO) GUIDE WIRE
K914693 · Depuy, Inc. · Dec 1991
SONGER(TM) CABLE SYSTEM
K913735 · Danek Medical, Inc. · Nov 1991
FX-CABLELOK SYSTEM
K912207 · Biodynamic Technologies, Inc. · Jul 1991
STERNOTOMY CABLE, SONGER CABLE SYSTEM
K903676 · Danek Medical, Inc. · Sep 1990
MENNEN BONE FIXATION DEVICE
K892411 · Dentsply Intl. · Jan 1990
BONE FIXATION WIRE
K882967 · Baxter Healthcare Corp · Sep 1988