Cleared Traditional

K871453 - ZWEYMUELLER-SL HIP PROSTHESIS STEM

K871453 is an FDA 510(k) clearance for ZWEYMUELLER-SL HIP PROSTHESIS STEM, 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 91-day FDA review.

K871453 · Allo Pro Corp. · Orthopedic device
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Jul 1987
Decision
91d
Days
Class 3
Risk

K871453 is an FDA 510(k) clearance for the ZWEYMUELLER-SL HIP PROSTHESIS STEM. 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 July 13, 1987 after a review of 91 days - within the typical 510(k) review window.

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 - K871453

510(k) Number K871453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1987
Decision Date July 13, 1987
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
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 K871453.
SAMUELSON ACETABULAR CUP
K872985 · Protek, Inc. · Oct 1987
SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.
K870923 · Protek, Inc. · Sep 1987
CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.
K870924 · Protek, Inc. · Sep 1987
MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT
K871956 · Downs Surgical , Ltd. · Jun 1987
RING UPM TOTAL HIP REPLACEMENT
K864515 · Downs Surgical , Ltd. · Mar 1987
(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT
K861723 · Osteonics Corp. · Jun 1986