Cleared Traditional

K842466 - TITANIUM MITTELMEIER TYPE ACETABULAR

K842466 is an FDA 510(k) clearance for TITANIUM MITTELMEIER TYPE ACETABULAR, manufactured by American Ortomed Corp.. The device is a Class 3 Orthopedic device with product code KWA cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K842466 · American Ortomed Corp. · Orthopedic device
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Jan 1985
Decision
219d
Days
Class 3
Risk

K842466 is an FDA 510(k) clearance for the TITANIUM MITTELMEIER TYPE ACETABULAR. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by American Ortomed Corp. (Poughkeepsie, US). The FDA issued a Cleared decision on January 30, 1985 after a review of 219 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 - K842466

510(k) Number K842466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1984
Decision Date January 30, 1985
Days to Decision 219 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 122d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

KWA Device Classification - Class 3, Premarket Approval

Product Code KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3330
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

All 110
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K842466.
ZIMMER THREADED ACETABULAR CUP
K850766 · Zimmer, Inc. · May 1985
PROFILE FEMORAL HIP
K850055 · Depuy, Inc. · Apr 1985
WEILL CEMENTLESS THREADED ACETABULAR CUP
K844943 · Advanced Biosearch Assn. · Mar 1985
TOTAL HIP, LORD MADREPORIC
K780330 · Howmedica Corp. · May 1978
K842466 · TITANIUM MITTELMEIER TYPE ACETABULAR
Download PDF American Ortomed Corp.