Cleared Traditional

K770184 - BI-CENTRIC ENDOPROSTHESES

K770184 is the FDA 510(k) clearance for BI-CENTRIC ENDOPROSTHESES by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDG) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K770184 · Howmedica Corp. · Orthopedic device
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Feb 1977
Decision
12d
Days
Class 2
Risk

K770184 is an FDA 510(k) clearance for the BI-CENTRIC ENDOPROSTHESES. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on February 8, 1977 after a review of 12 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 Howmedica Corp. devices

Submission Details

510(k) Number K770184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1977
Decision Date February 08, 1977
Days to Decision 12 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
110d faster than avg
Panel avg: 122d · This submission: 12d
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 42
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K770184.
KERBOULL-CHARNLEY CUP SPECIAL MODEL
K770471 · Howmedica Corp. · Mar 1977
LAGRANGE LETOURNEL TOTAL HIP FEMORAL
K770473 · Howmedica Corp. · Mar 1977
WATSON-FARRAR TOTAL HIP REPLACEMENT
K770219 · Orthopedic Equipment Co., Inc. · Feb 1977
SPARBARO TYPE TOTAL HIP
K761146 · Orthopedic Equipment Co., Inc. · Dec 1976
CHARNLEY CONGENITAL HIP FEMUR (85-3060)
K761002 · Codman & Shurtleff, Inc. · Nov 1976
CHARNLEY CONGENITAL HIP FEMUR (85-3061)
K761003 · Codman & Shurtleff, Inc. · Nov 1976