Cleared Traditional

K820995 - MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS

K820995 is an FDA 510(k) clearance for MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS, manufactured by Ludek Optics, Inc.. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K820995 · Ludek Optics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 1982
Decision
46d
Days
Class 2
Risk

K820995 is an FDA 510(k) clearance for the MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Ludek Optics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1982 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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.

FDA 510(k) Submission Details - K820995

510(k) Number K820995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1982
Decision Date May 25, 1982
Days to Decision 46 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 122d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRO Device Classification - Class 2, Special Controls

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 84
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K820995.
NATURALYTE BICARBONATE DIALYSATE 4400
K823115 · Erika, Inc. · Dec 1982
BARD ENDO LINK INTRACONDYLAR ROTATING
K821476 · C.R. Bard, Inc. · Jun 1982
VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.
K821340 · Intermedics Orthopedics · May 1982
INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL
K810520 · Zimmer, Inc. · Mar 1981
K820995 · MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS
Download PDF Ludek Optics, Inc.