Cleared Traditional

DOSIMETRIC RELEASE OF GAMMA RADIATION (K832211) - FDA 510(k) Clearance

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

K832211 · Kirschner Medical Corp. · Orthopedic device
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Sep 1983
Decision
85d
Days
Class 2
Risk

K832211 is an FDA 510(k) clearance for the DOSIMETRIC RELEASE OF GAMMA RADIATION. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Kirschner Medical Corp. devices

Submission Details

510(k) Number K832211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1983
Decision Date September 29, 1983
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K832211.
GALANTE FIBER METAL TOTAL HIP
K833912 · Zimmer, Inc. · Dec 1983
FREEMAN ACETABULAR CUP
K832958 · Depuy, Inc. · Oct 1983
MMS ACETABULAR CUPS
K830361 · 3M Company · Sep 1983
P.C.A. HIP SYSTEM
K831373 · Howmedica Corp. · Aug 1983
INTERFERENCE MEDULLARY FIT -IMF-HIP
K831314 · Depuy, Inc. · Jul 1983
MILWAUKEE AUSTIN MOORE TOTAL HIP
K830314 · Biomet, Inc. · Jun 1983