Cleared Traditional

K972760 - LINK

K972760 is an FDA 510(k) clearance for LINK, manufactured by Link America, Inc.. The device is a Class 2 Orthopedic device with product code JDJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K972760 · Link America, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
90d
Days
Class 2
Risk

K972760 is an FDA 510(k) clearance for the LINK, ACETABULAR REVISION MESH CUP. Classified as Mesh, Surgical, Acetabular, Hip, Prosthesis (product code JDJ), Class II - Special Controls.

Submitted by Link America, Inc. (Denville, US). The FDA issued a Cleared decision on October 22, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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: Standard predicate-based submission. Standard predicate reliance. 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 - K972760

510(k) Number K972760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1997
Decision Date October 22, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDJ Device Classification - Class 2, Special Controls

Product Code JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis

Devices cleared under the same product code (JDJ) and FDA review panel - the closest regulatory comparables to K972760.
OSTEONICS RESTORATION ACETABULAR RING
K970957 · Osteonics Corp. · Jun 1997
EXETER MESH
K963940 · Howmedica, Inc. · Feb 1997
REFLECTION ACETABULAR REINFORCEMENT RINGS
K962541 · Smith & Nephew Richards, Inc. · Sep 1996
PROTRUSION CAGES
K962007 · Depuy, Inc. · Aug 1996
OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS
K925883 · Osteonics Corp. · Jun 1993
INTERMEDICS APR(TM) II FEMORAL COMPONENT
K890450 · Intermedics Orthopedics · Aug 1989