Cleared Traditional

K760106 - PROSTHESIS

K760106 is an FDA 510(k) clearance for PROSTHESIS, manufactured by Orthopedic Equipment Co., Inc.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K760106 · Orthopedic Equipment Co., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1976
Decision
26d
Days
Class 2
Risk

K760106 is an FDA 510(k) clearance for the PROSTHESIS, TOTAL HIP-FEMORAL. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Orthopedic Equipment Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1976 after a review of 26 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 Orthopedic Equipment Co., Inc. devices

FDA 510(k) Submission Details - K760106

510(k) Number K760106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1976
Decision Date July 20, 1976
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
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 44
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K760106.
CHARNLEY FEMORAL COMPONENT
K760974 · Codman & Shurtleff, Inc. · Nov 1976
CHARNLEY REVISION SET
K760976 · Codman & Shurtleff, Inc. · Nov 1976
TOTAL HIP REPLACEMENT,LAGRANGE-LETOURNEL
K760651 · Orthopedic Equipment Co., Inc. · Oct 1976
PROSTHESIS, TOTAL HIP-TEST FEMORAL
K760107 · Orthopedic Equipment Co., Inc. · Jul 1976
PROSTHESIS, TOTAL HIP-TEST CUP
K760108 · Orthopedic Equipment Co., Inc. · Jul 1976