Cleared Traditional

K961388 - ATLAS III ACETABULAR CUP

K961388 is an FDA 510(k) clearance for ATLAS III ACETABULAR CUP, manufactured by Fournitures Hospitalieres. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K961388 · Fournitures Hospitalieres · Orthopedic device
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Apr 1997
Decision
358d
Days
Class 2
Risk

K961388 is an FDA 510(k) clearance for the ATLAS III ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Fournitures Hospitalieres (Rockville, US). The FDA issued a Cleared decision on April 3, 1997 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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. Elevated predicate reliance 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 Fournitures Hospitalieres devices

FDA 510(k) Submission Details - K961388

510(k) Number K961388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1996
Decision Date April 03, 1997
Days to Decision 358 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
236d slower than avg
Panel avg: 122d · This submission: 358d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 148
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K961388.
KAR
K961732 · Landos, Inc. · Jul 1997
OSTEONICS ACETABULAR WEDGE SYSTEM
K971422 · Osteonics Corp. · May 1997
OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM
K970394 · Osteonics Corp. · Apr 1997
HA GLOBAL TAPER (GT) TAPERED HIP STEM
K970337 · Smith & Nephew, Inc., Orthopaedic Div. · Feb 1997
OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)
K963959 · Osteonics Corp. · Dec 1996
APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)
K954800 · Intermedics Orthopedics · Apr 1996