INBONE II TOTAL ANKLE REPLACEMENT— 510(k) K100886
Substantially EquivalentWrightmedicaltechnologyinc
FDA 510(k) clearance K100886 for INBONE II TOTAL ANKLE REPLACEMENT, Substantially Equivalent on 2010-08-26. Applicant: Wrightmedicaltechnologyinc. Device class: 2.
Clearance details
- Applicant
- Wrightmedicaltechnologyinc
- 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
- Arlington, TN, US
Recent devices under product code HSN
view allMore clearances from Wrightmedicaltechnologyinc
view allAdverse 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 K100886
K-number listed on FDA's recall record- Z-0315-2022 — INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
- Z-0316-2022 — INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100886.
Data sourced from openFDA. This site is unofficial and independent of the FDA.