Cleared Traditional

K943696 - ALL POLYETHYLENE CEMENTED ACETABULAR CUP

K943696 is an FDA 510(k) clearance for ALL POLYETHYLENE CEMENTED ACETABULAR CUP, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K943696 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
292d
Days
Class 2
Risk

K943696 is an FDA 510(k) clearance for the ALL POLYETHYLENE CEMENTED ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 17, 1995 after a review of 292 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K943696

510(k) Number K943696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1994
Decision Date May 17, 1995
Days to Decision 292 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
170d slower than avg
Panel avg: 122d · This submission: 292d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 516
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K943696.
ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
K950418 · Wrightmedicaltechnologyinc · Jun 1995
S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS
K951084 · Joint Medical Products Corp. · May 1995
OSTEONICS(R) CCR HIP STEM SERIES
K945574 · Osteonics Corp. · May 1995
ALPHA SYSTEM
K950312 · Zimmer, Inc. · May 1995
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
K945115 · Biomet, Inc. · May 1995
INDEX ACETABULAT COMPONENT
K950761 · Biomet, Inc. · May 1995