Integra Total Ankle Replacement System— 510(k) K151459
Substantially EquivalentAscension Orthopedics
FDA 510(k) clearance K151459 for Integra Total Ankle Replacement System, Substantially Equivalent on 2015-08-31. Applicant: Ascension Orthopedics. Device class: 2.
Clearance details
- Applicant
- Ascension Orthopedics
- Product code
- Code HSN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3110
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code HSN
view allMore clearances from Ascension Orthopedics
view all- K182878 — Integra Salto Total Ankle System
- K162153 — Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System
- K160830 — Integra External Fixation System
- K152047 — INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
- K152527 — Integra DigiFuse Cannulated Intramedullary Fusion System
Adverse events under product code HSN
product code HSN- Death
- 3
- Injury
- 4,711
- Total
- 4,714
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K151459
K-number listed on FDA's recall record- Z-1192-2017 — Integra Cadence Total Ankle System
- Z-2086-2016 — Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151459.
Data sourced from openFDA. This site is unofficial and independent of the FDA.