Cleared Traditional

K790762 - PLATFORM TCCK TOTAL KNEE

K790762 is an FDA 510(k) clearance for PLATFORM TCCK TOTAL KNEE, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K790762 · Biomet, Inc. · Orthopedic device
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May 1979
Decision
27d
Days
Class 2
Risk

K790762 is an FDA 510(k) clearance for the PLATFORM TCCK TOTAL KNEE. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1979 after a review of 27 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K790762

510(k) Number K790762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1979
Decision Date May 14, 1979
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRY Device Classification - Class 2, Special Controls

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 75
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K790762.
RANAWAT ESF TOTAL CONDYLAR KNEE
K802446 · Howmedica Corp. · Oct 1980
RMC KNEE METAL SHOE TIBIAL COMPONENTS
K792619 · Richard'S Medical Equip., Inc. · Feb 1980
LIVERPOOL KNEE PROSTHESIS
K792325 · Downs Surgical , Ltd. · Jan 1980
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