Cleared Traditional

K761146 - SPARBARO TYPE TOTAL HIP

K761146 is an FDA 510(k) clearance for SPARBARO TYPE TOTAL HIP, 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 20-day FDA review.

K761146 · Orthopedic Equipment Co., Inc. · Orthopedic device
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Dec 1976
Decision
20d
Days
Class 2
Risk

K761146 is an FDA 510(k) clearance for the SPARBARO TYPE TOTAL HIP. 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 December 16, 1976 after a review of 20 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 - K761146

510(k) Number K761146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1976
Decision Date December 16, 1976
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
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 K761146.
LAGRANGE LETOURNEL TOTAL HIP FEMORAL
K770473 · Howmedica Corp. · Mar 1977
WATSON-FARRAR TOTAL HIP REPLACEMENT
K770219 · Orthopedic Equipment Co., Inc. · Feb 1977
BI-CENTRIC ENDOPROSTHESES
K770184 · Howmedica Corp. · Feb 1977
CHARNLEY CONGENITAL HIP FEMUR (85-3060)
K761002 · Codman & Shurtleff, Inc. · Nov 1976
CHARNLEY CONGENITAL HIP FEMUR (85-3061)
K761003 · Codman & Shurtleff, Inc. · Nov 1976
CHARNLEY FEMORAL COMPONENT
K760974 · Codman & Shurtleff, Inc. · Nov 1976