Cleared Traditional

K854935 - LINK METAL-BACKED ACETABULAR CUPS

K854935 is an FDA 510(k) clearance for LINK METAL-BACKED ACETABULAR CUPS, manufactured by Link America, Inc.. The device is a Class 3 Orthopedic device with product code JDL cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K854935 · Link America, Inc. · Orthopedic device
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Mar 1986
Decision
85d
Days
Class 3
Risk

K854935 is an FDA 510(k) clearance for the LINK METAL-BACKED ACETABULAR CUPS. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Link America, Inc. (East Hanavor, US). The FDA issued a Cleared decision on March 5, 1986 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3320 - 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 Link America, Inc. devices

FDA 510(k) Submission Details - K854935

510(k) Number K854935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1985
Decision Date March 05, 1986
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

JDL Device Classification - Class 3, Premarket Approval

Product Code JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3320
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 - JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)

All 37
Devices cleared under the same product code (JDL) and FDA review panel - the closest regulatory comparables to K854935.
KM-4(TM) METAL-BACKED ACETABULAR CUP
K870867 · Kirschner Medical Corp. · May 1987
KM-3 ACETABULAR COMPONENT
K855042 · Kirschner Medical Corp. · Mar 1986
DIMENSION TOTAL HIP PROSTHESIS POROUS COATED
K854107 · Kirschner Medical Corp. · Mar 1986
LIDGRER-LUND ACETABULAR SOCKETS
K852369 · Link America, Inc. · Jun 1985
MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA
K850793 · Intermedics Orthopedics · May 1985
MICRO-STRUC. ACETABULAR COMPON- MC2P
K850352 · Osteonics Corp. · Apr 1985