Cleared Traditional

MONOFIXATEUR (K854336) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854336 · Ortopedia GmbH · Orthopedic device
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Mar 1986
Decision
128d
Days
Class 2
Risk

K854336 is an FDA 510(k) clearance for the MONOFIXATEUR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Ortopedia GmbH (Washington, US). The FDA issued a Cleared decision on March 5, 1986 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Ortopedia GmbH devices

Submission Details

510(k) Number K854336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date March 05, 1986
Days to Decision 128 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 409
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K854336.
VECSEI EXPANDING SCREW
K892925 · Howmedica Corp. · Aug 1989
OMNIFIT BONE SCREW
K873251 · Osteonics Corp. · Sep 1987
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
K864633 · Howmedica Corp. · Dec 1986
BONE SCREW
K831873 · W.L. Gore & Associates, Inc. · Aug 1983
SEIDEL INTRAMEDULLARY PLUG
K792205 · Howmedica Corp. · Dec 1979
HERBERT BONE SCREW
K792022 · Zimmer, Inc. · Oct 1979