Cleared Traditional

K874100 - AML CALCAR FEMORAL PROSTHESIS

K874100 is an FDA 510(k) clearance for AML CALCAR FEMORAL PROSTHESIS, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K874100 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K874100

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.

JDG Device Classification - Class 2, Special Controls

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 43
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K874100.
INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE
K911595 · Dow Corning Wright · Jul 1991
OPTI-FIX COLLARED FEMORAL COMPONENTS
K874868 · Richards Medical Co., Inc. · Jan 1988
PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K874575 · Dow Corning Wright · Jan 1988
CTI STRAIGHT STEM
K873627 · Orthopedic Systems, Inc. · Dec 1987
WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO
K874740 · Dow Corning Wright · Dec 1987
THOMPSON HIP PROSTHESIS
K874617 · Orthopedic Systems, Inc. · Dec 1987