Cleared Traditional

K831512 - DOSIMETRY RELEASE OF RADIATION STERILIZ

K831512 is an FDA 510(k) clearance for DOSIMETRY RELEASE OF RADIATION STERILIZ, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K831512 · Biomet, Inc. · Orthopedic device
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Sep 1983
Decision
140d
Days
Class 2
Risk

K831512 is an FDA 510(k) clearance for the DOSIMETRY RELEASE OF RADIATION STERILIZ. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K831512

510(k) Number K831512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1983
Decision Date September 29, 1983
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDK Device Classification - Class 2, Special Controls

Product Code JDK Prosthesis, Hip, Cement Restrictor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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.