Cleared Traditional

K851367 - HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION (FDA 510(k) Clearance)

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

K851367 · Orthomatrix, Inc. · Chemistry device
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May 1985
Decision
46d
Days
Class 2
Risk

K851367 is an FDA 510(k) clearance for the HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Orthomatrix, Inc. (Dublin, US). The FDA issued a Cleared decision on May 21, 1985 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 872.3640 - the FDA in vitro diagnostics and chemistry 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 Orthomatrix, Inc. devices

Submission Details

510(k) Number K851367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1985
Decision Date May 21, 1985
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 Chemistry devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

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