ECLIPSE TOTAL ANKLE IMPLANT— 510(k) K061749

Clearance details

Applicant

Kinetikos Medical, Inc.

Product code

Code HSN

Device class

Class 2

Regulation

21 CFR 888.3110

Advisory panel

Orthopedic

Date received

2006-06-21

Decision date

2006-11-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

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• K061465 — KMI CEMENT RESTRICTOR IMPLANT2006-10-05
• K051611 — MBARESORB IMPLANT2005-09-06
• K041461 — KMI DISTAL VOLAR RADIUS PLATE SYSTEM2004-08-16
• K032806 — KATALYST RADIAL HEAD IMPLANT2004-04-16
• K040356 — KOMPRESSOR SCREW SYSTEM2004-03-01

Death

3

Injury

4,711

Total

4,714

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →