Cleared Traditional

K872985 - SAMUELSON ACETABULAR CUP

K872985 is an FDA 510(k) clearance for SAMUELSON ACETABULAR CUP, 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 62-day FDA review.

K872985 · Protek, Inc. · Orthopedic device
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Oct 1987
Decision
62d
Days
Class 3
Risk

K872985 is an FDA 510(k) clearance for the SAMUELSON ACETABULAR CUP. 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 October 1, 1987 after a review of 62 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 Protek, Inc. devices

FDA 510(k) Submission Details - K872985

510(k) Number K872985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1987
Decision Date October 01, 1987
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
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 K872985.
SAMUELSON SCREWLOC CUP
K882671 · Protek, Inc. · Oct 1988
ATH METAL:UHMWPE TOTAL HIP SYSTEM
K882675 · Kinamed, Inc. · Aug 1988
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
K872768 · Osteonics Corp. · Jan 1988
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