Cleared Traditional

K853730 - FREEMAN-SAMUELSON MARK II PRESS-FIT TOT...

K853730 is an FDA 510(k) clearance for FREEMAN-SAMUELSON MARK II PRESS-FIT TOT..., manufactured by Protek, Inc.. The device is a Class 2 Orthopedic device with product code MBV cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K853730 · Protek, Inc. · Orthopedic device
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Feb 1986
Decision
165d
Days
Class 2
Risk

K853730 is an FDA 510(k) clearance for the FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer (product code MBV), Class II - Special Controls.

Submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 18, 1986 after a review of 165 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Protek, Inc. devices

FDA 510(k) Submission Details - K853730

510(k) Number K853730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1985
Decision Date February 18, 1986
Days to Decision 165 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
43d slower than avg
Panel avg: 122d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBV Device Classification - Class 2, Special Controls

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

All 11
Devices cleared under the same product code (MBV) and FDA review panel - the closest regulatory comparables to K853730.
OFFSET TIBIAL TRAY
K010212 · Biomet, Inc. · Feb 2001
TRICON-M TOTAL KNEE SYSTEM
K884824 · Richards Medical Co., Inc. · Nov 1989
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE
K873429 · Protek, Inc. · Oct 1987
TRICON M TOTAL KNEE SYSTEM
K833200 · Richards Medical Co., Inc. · Nov 1983
POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
K831441 · Depuy, Inc. · Sep 1983
RMC TOTAL KNEE SYSTEM
K823837 · Richard'S Medical Equip., Inc. · Mar 1983