Cleared Traditional

K781608 - CENTRAL PEG TIBIAL COMPONENT

K781608 is the FDA 510(k) clearance for CENTRAL PEG TIBIAL COMPONENT by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HRY) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K781608 · Howmedica Corp. · Orthopedic device
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Sep 1978
Decision
9d
Days
Class 2
Risk

K781608 is an FDA 510(k) clearance for the CENTRAL PEG TIBIAL COMPONENT. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1978 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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 K781608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1978
Decision Date September 27, 1978
Days to Decision 9 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
113d faster than avg
Panel avg: 122d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 72
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K781608.
ANAMETRIC TIBIAL COMPONENT METAL TRAY
K790348 · Howmedica Corp. · Mar 1979
TOTAL CONDYLAR KNEE PROSTHESIS
K790349 · Howmedica Corp. · Mar 1979
POSTERIOR CRUCIATE CONDYLAR TIBIAL
K790350 · Howmedica Corp. · Mar 1979
TOTAL KNEE SYSTEM
K780299 · Richard'S Medical Equip., Inc. · Apr 1978
TOTAL TIBIAL KNEE
K761278 · Depuy, Inc. · Jan 1977
GEOMEDIC ANAMETRIC TOTAL KNEE
K760842 · Howmedica Corp. · Oct 1976