Cleared Traditional

K892411 - MENNEN BONE FIXATION DEVICE

K892411 is an FDA 510(k) clearance for MENNEN BONE FIXATION DEVICE, manufactured by Dentsply Intl.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K892411 · Dentsply Intl. · Orthopedic device
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Jan 1990
Decision
273d
Days
Class 2
Risk

K892411 is an FDA 510(k) clearance for the MENNEN BONE FIXATION DEVICE. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on January 5, 1990 after a review of 273 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K892411

510(k) Number K892411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1989
Decision Date January 05, 1990
Days to Decision 273 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 122d · This submission: 273d
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 110
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K892411.
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
BONE FIXATION WIRE
K882967 · Baxter Healthcare Corp · Sep 1988
STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM
K875156 · Richards Medical Co., Inc. · Jan 1988
ORTHOMET WIRE FOR SUTURE, CERCLAGE
K874919 · Orthomet, Inc. · Jan 1988