Cleared Traditional

K871857 - HPS II CALCAR FEMORAL PROSTHESIS

K871857 is the FDA 510(k) clearance for HPS II CALCAR FEMORAL PROSTHESIS by Depuy, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K871857 · Depuy, Inc. · Orthopedic device
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Jun 1987
Decision
41d
Days
Class 2
Risk

K871857 is an FDA 510(k) clearance for the HPS II CALCAR FEMORAL 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 June 23, 1987 after a review of 41 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 K871857 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 13, 1987
Decision Date June 23, 1987
Days to Decision 41 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 122d · This submission: 41d
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 K871857.
MCCUTCHEN ACETABULAR CUP PROSTHESIS
K872732 · Dow Corning Wright · Oct 1987
BIOPRO 32MM BALL
K872856 · Biopro, Inc. · Aug 1987
MURRAY/WELCH TOTAL HIP SYSTEM
K871402 · Kirschner Medical Corp. · Jul 1987
OMNIFIT II HIP PROSTHESES: CEMENT FIXATION
K870235 · Osteonics Corp. · May 1987
MODIFIED PROFILE HIP PMMA CEMENT SPACER
K871510 · Depuy, Inc. · May 1987
KIRSCHNER MODULAR HIP SYSTEM
K871401 · Kirschner Medical Corp. · May 1987