Cleared Traditional

K874740 - WHITESIDE ORTHOLOC CALCAR REPLACEMENT H...

K874740 is an FDA 510(k) clearance for WHITESIDE ORTHOLOC CALCAR REPLACEMENT H..., manufactured by Dow Corning Wright. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K874740 · Dow Corning Wright · Orthopedic device
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Dec 1987
Decision
30d
Days
Class 2
Risk

K874740 is an FDA 510(k) clearance for the WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on December 18, 1987 after a review of 30 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 Dow Corning Wright devices

FDA 510(k) Submission Details - K874740

510(k) Number K874740 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 18, 1987
Decision Date December 18, 1987
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K874740.
PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K874575 · Dow Corning Wright · Jan 1988
AML CALCAR FEMORAL PROSTHESIS
K874100 · Depuy, Inc. · Dec 1987
CTI STRAIGHT STEM
K873627 · Orthopedic Systems, Inc. · Dec 1987
THOMPSON HIP PROSTHESIS
K874617 · Orthopedic Systems, Inc. · Dec 1987
HOWMEDICA PCA COLLARED FEMORAL STEM
K873458 · Howmedica Corp. · Sep 1987
PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM
K873089 · Howmedica Corp. · Sep 1987