Cleared Traditional

RADIAL HEAD PROSTHESIS (K811451) - FDA 510(k) Clearance

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

K811451 · Cintor Orthopaedic Div. · Orthopedic device
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Jun 1981
Decision
18d
Days
Class 2
Risk

K811451 is an FDA 510(k) clearance for the RADIAL HEAD PROSTHESIS. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Cintor Orthopaedic Div. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1981 after a review of 18 days - a notably fast clearance cycle.

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: 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 Cintor Orthopaedic Div. devices

Submission Details

510(k) Number K811451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1981
Decision Date June 09, 1981
Days to Decision 18 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 122d · This submission: 18d
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 15
Devices cleared under the same product code (JDB) and FDA review panel - the closest regulatory comparables to K811451.
POROCOAT MARK IV ELBOW
K823473 · Depuy, Inc. · Jan 1983
SUFACE REPLACEMENT ELBOW
K820957 · Howmedica Corp. · Jul 1982
ARIZONA RADIO CAPITELLAR TOTAL ELBOW
K812322 · Zimmer, Inc. · Jan 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