Cleared Traditional

K854336 - MONOFIXATEUR

K854336 is an FDA 510(k) clearance for MONOFIXATEUR, manufactured by Ortopedia GmbH. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 128-day FDA review.

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.

FDA 510(k) Submission Details - K854336

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
Combination Product No
PCCP Authorized No
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.

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 1062
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K854336.
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
K864633 · Howmedica Corp. · Dec 1986
CANCELLOUS BONE SCREW
K864626 · Dow Corning Wright · Dec 1986
WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW
K862230 · Buckman Co., Inc. · Aug 1986
REESE ARTHRODESIS SCREW
K860323 · Osteotomy Guide Co. · Feb 1986
ACROMED CANCELLOUS BONE SCREW
K860017 · Buckman Co., Inc. · Feb 1986
MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P
K855031 · Advanced Biosearch Assn. · Jan 1986
K854336 · MONOFIXATEUR
Download PDF Ortopedia GmbH