Cleared Traditional

AML CALCAR FEMORAL PROSTHESIS (K874100) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K874100 · Depuy, Inc. · Orthopedic device
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Dec 1987
Decision
84d
Days
Class 2
Risk

K874100 is an FDA 510(k) clearance for the AML CALCAR FEMORAL PROSTHESIS. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 31, 1987 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 K874100 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 08, 1987
Decision Date December 31, 1987
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

All 25
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K874100.
CO-CR ANSWER FEMORAL COMPONENT
K931194 · Biomet, Inc. · May 1994
BRIDGE(TM) HIP SYSTEM
K933871 · Wrightmedicaltechnologyinc · Feb 1994
STABILITY HIP STEM WITH POROCOAT
K915787 · Depuy, Inc. · Apr 1993
HOWMEDICA PCA COLLARED FEMORAL STEM
K873458 · Howmedica Corp. · Sep 1987
PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM
K873089 · Howmedica Corp. · Sep 1987
HOWMEDICA FEMORAL COMPONENT HIP SYS 6259
K851566 · Howmedica Corp. · Jul 1985