Cleared Traditional

K851213 - ZWEYMULLER CUP

K851213 is an FDA 510(k) clearance for ZWEYMULLER CUP, manufactured by Allo Pro Corp.. The device is a Class 3 Orthopedic device with product code KWA cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K851213 · Allo Pro Corp. · Orthopedic device
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May 1985
Decision
63d
Days
Class 3
Risk

K851213 is an FDA 510(k) clearance for the ZWEYMULLER CUP. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Allo Pro Corp. (Clearwater, US). The FDA issued a Cleared decision on May 28, 1985 after a review of 63 days - a notably fast clearance 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.

View all Allo Pro Corp. devices

FDA 510(k) Submission Details - K851213

510(k) Number K851213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1985
Decision Date May 28, 1985
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 122d · This submission: 63d
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 105
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K851213.
OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES
K851404 · Osteonics Corp. · Jun 1985
LINK CEMENTLESS SCREW-IN ACETABULAR CUP
K843940 · Waldemar Link GmbH & Co. KG · Jun 1985
LINK CEMENTLESS SCREW-IN ACETABULAR CUP
K843950 · Waldemar Link GmbH & Co. KG · Jun 1985
PM CEMENTLESS SCREW-IN ACETABULAR CUP
K850773 · Advanced Biosearch Assn. · May 1985
ZIMMER THREADED ACETABULAR CUP
K850766 · Zimmer, Inc. · May 1985
PROFILE FEMORAL HIP
K850055 · Depuy, Inc. · Apr 1985