Cleared Traditional

K780317 - TOTAL HIP SYSTEM

K780317 is the FDA 510(k) clearance for TOTAL HIP SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K780317 · Howmedica Corp. · Orthopedic device
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Mar 1978
Decision
10d
Days
Class 2
Risk

K780317 is an FDA 510(k) clearance for the TOTAL HIP SYSTEM, HARRIS HD2. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on March 6, 1978 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 K780317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1978
Decision Date March 06, 1978
Days to Decision 10 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
112d faster than avg
Panel avg: 122d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 435
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K780317.
3M TITANIUM ALLOY TOTAL HIP SYSTEM 32MM
K800487 · 3M Company · Apr 1980
INTERPLANTA SP TOTAL HIP PROSTHESIS
K790488 · Waldemar Link GmbH & Co. KG · Mar 1979
CUP, ACETABULAR, LONG POSTERIOR WALL
K780398 · Orthopedic Equipment Co., Inc. · Mar 1978
PROSTHESIS, DOUBLE CUP
K780052 · Depuy, Inc. · Jan 1978
PROSTHESIS, HIP, TRAPEZOIDAL-28
K770908 · Zimmer, Inc. · May 1977