Cleared Traditional

K843940 - LINK CEMENTLESS SCREW-IN ACETABULAR CUP

K843940 is an FDA 510(k) clearance for LINK CEMENTLESS SCREW-IN ACETABULAR CUP, manufactured by Waldemar Link GmbH & Co. KG. The device is a Class 3 Orthopedic device with product code KWA cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K843940 · Waldemar Link GmbH & Co. KG · Orthopedic device
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Jun 1985
Decision
237d
Days
Class 3
Risk

K843940 is an FDA 510(k) clearance for the LINK CEMENTLESS SCREW-IN ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Waldemar Link GmbH & Co. KG (E. Hanover, US). The FDA issued a Cleared decision on June 3, 1985 after a review of 237 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 Waldemar Link GmbH & Co. KG devices

FDA 510(k) Submission Details - K843940

510(k) Number K843940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1984
Decision Date June 03, 1985
Days to Decision 237 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
115d slower than avg
Panel avg: 122d · This submission: 237d
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 K843940.
KIRSCHNER SELF-TAPPING ACETABULAR CUP
K852351 · Kirschner Medical Corp. · Aug 1985
HOWMEDICA THREADED ACETABULAR COMPONENT
K850840 · Pfizer, Inc. · Jul 1985
OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES
K851404 · Osteonics Corp. · Jun 1985
LINK CEMENTLESS SCREW-IN ACETABULAR CUP
K843950 · Waldemar Link GmbH & Co. KG · Jun 1985
ZIMMER THREADED ACETABULAR CUP
K850766 · Zimmer, Inc. · May 1985
PROFILE FEMORAL HIP
K850055 · Depuy, Inc. · Apr 1985