Cleared Traditional

FREEMAN/SAMUELSON TOTAL KNEE (K830408) - FDA 510(k) Clearance

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

K830408 · Depuy, Inc. · Orthopedic device
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Feb 1983
Decision
17d
Days
Class 2
Risk

K830408 is an FDA 510(k) clearance for the FREEMAN/SAMUELSON TOTAL KNEE. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer (product code MBV), Class II - Special Controls.

Submitted by Depuy, Inc. (Walker, US). The FDA issued a Cleared decision on February 24, 1983 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Depuy, Inc. devices

Submission Details

510(k) Number K830408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1983
Decision Date February 24, 1983
Days to Decision 17 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
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBV Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - MBV Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer

Devices cleared under the same product code (MBV) and FDA review panel - the closest regulatory comparables to K830408.
OFFSET TIBIAL TRAY
K010212 · Biomet, Inc. · Feb 2001
POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
K831441 · Depuy, Inc. · Sep 1983
ICLH TIBIAL PLATEAU
K802921 · Depuy, Inc. · Jan 1981
KNEE, TOTAL, FEMORAL & TIBIAL
K780904 · Depuy, Inc. · Jun 1978
TIBIAL PLATEU
K780284 · Depuy, Inc. · Mar 1978