Cleared Traditional

K870924 - CLX ACETABULAR CUP (WAGNER) FOR CEMENTL...

K870924 is an FDA 510(k) clearance for CLX ACETABULAR CUP (WAGNER) FOR CEMENTL..., manufactured by Protek, Inc.. The device is a Class 3 Orthopedic device with product code KWA cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K870924 · Protek, Inc. · Orthopedic device
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Sep 1987
Decision
194d
Days
Class 3
Risk

K870924 is an FDA 510(k) clearance for the CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 14, 1987 after a review of 194 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.

View all Protek, Inc. devices

FDA 510(k) Submission Details - K870924

510(k) Number K870924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1987
Decision Date September 14, 1987
Days to Decision 194 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
72d slower than avg
Panel avg: 122d · This submission: 194d
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 98
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K870924.
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
K872768 · Osteonics Corp. · Jan 1988
SAMUELSON ACETABULAR CUP
K872985 · Protek, Inc. · Oct 1987
SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.
K870923 · 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