Cleared Traditional

K961619 - DEPUY ENDURANCE CALCAR HIP PROSTHESIS

K961619 is the FDA 510(k) clearance for DEPUY ENDURANCE CALCAR HIP PROSTHESIS by Depuy, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K961619 · Depuy, Inc. · Orthopedic device
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Jul 1996
Decision
77d
Days
Class 2
Risk

K961619 is an FDA 510(k) clearance for the DEPUY ENDURANCE CALCAR HIP PROSTHESIS. 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 July 12, 1996 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy, Inc. devices

Submission Details

510(k) Number K961619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1996
Decision Date July 12, 1996
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K961619.
COLLARLESS POLISHED TAPER HIP PROSTHESIS
K960658 · Zimmer, Inc. · Jul 1996
NATURAL HIP SYSTEM - DRG HIP STEM
K961799 · Intermedics Orthopedics · Jul 1996
NATURAL HIP SYSTEM
K960258 · Intermedics Orthopedics · Jul 1996
FOUNDATION 9MM FORGED CEMENTED STEM
K961890 · Encore Orthopedics, Inc. · Jun 1996
PROTEK LOW PROFILE ACETABULAR CUP
K960025 · Intermedics Orthopedics · Jun 1996
BURCH/SCHNEIDER REINFORCEMENT CAGE
K960678 · Intermedics Orthopedics · May 1996