Cleared Traditional

ARIZONA RADIO CAPITELLAR TOTAL ELBOW (K812322) - FDA 510(k) Clearance

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

K812322 · Zimmer, Inc. · Orthopedic device
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Jan 1982
Decision
140d
Days
Class 2
Risk

K812322 is an FDA 510(k) clearance for the ARIZONA RADIO CAPITELLAR TOTAL ELBOW. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 4, 1982 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 888.3160 - 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 Zimmer, Inc. devices

Submission Details

510(k) Number K812322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1981
Decision Date January 04, 1982
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
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.

Device Classification

Product Code JDB Prosthesis, Elbow, Semi-constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3160
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 - JDB Prosthesis, Elbow, Semi-constrained, Cemented

All 14
Devices cleared under the same product code (JDB) and FDA review panel - the closest regulatory comparables to K812322.
SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM
K880188 · Howmedica Corp. · Mar 1988
POROCOAT MARK IV ELBOW
K823473 · Depuy, Inc. · Jan 1983
SUFACE REPLACEMENT ELBOW
K820957 · Howmedica Corp. · Jul 1982
PRITCHARD SURFACE REPLACEMENT ELBOW
K810847 · Depuy, Inc. · May 1981
TRIAXIAL
K802348 · Johnson & Johnson Professionals, Inc. · Feb 1981
HELFET ELBOW PROSTHESIS
K802460 · Depuy, Inc. · Nov 1980