Cleared Traditional

K821341 - IOI METAL BACKED TIBIAL COMPONENT (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K821341 · Intermedics Orthopedics · Orthopedic device
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Jun 1982
Decision
29d
Days
Class 2
Risk

K821341 is an FDA 510(k) clearance for the IOI METAL BACKED TIBIAL COMPONENT. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Mchenry, US). The FDA issued a Cleared decision on June 3, 1982 after a review of 29 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 Intermedics Orthopedics devices

Submission Details

510(k) Number K821341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1982
Decision Date June 03, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
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.