Cleared Traditional

K963940 - EXETER MESH

K963940 is an FDA 510(k) clearance for EXETER MESH, manufactured by Howmedica, Inc.. The device is a Class 2 Orthopedic device with product code JDJ cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K963940 · Howmedica, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
135d
Days
Class 2
Risk

K963940 is an FDA 510(k) clearance for the EXETER MESH. Classified as Mesh, Surgical, Acetabular, Hip, Prosthesis (product code JDJ), Class II - Special Controls.

Submitted by Howmedica, Inc. (Rutherford, US). The FDA issued a Cleared decision on February 13, 1997 after a review of 135 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 Howmedica, Inc. devices

FDA 510(k) Submission Details - K963940

510(k) Number K963940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1996
Decision Date February 13, 1997
Days to Decision 135 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 122d · This submission: 135d
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 K963940.
LINK, ACETABULAR REVISION MESH CUP
K972760 · Link America, Inc. · Oct 1997
OSTEONICS RESTORATION ACETABULAR RING
K970957 · Osteonics Corp. · Jun 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