TOPEZ TOTAL ANKLE REPLACEMENT— 510(k) K051023
Substantially EquivalentTopez Orthopedics, Inc.
FDA 510(k) clearance K051023 for TOPEZ TOTAL ANKLE REPLACEMENT, Substantially Equivalent on 2005-11-15. Applicant: Topez Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Topez Orthopedics, Inc.
- 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
- Boulder, CO, US
Recent devices under product code HSN
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 K051023
K-number listed on FDA's recall record- Z-0139-2023 — Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
- Z-0140-2023 — Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
- Z-1924-2020 — WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
- Z-0565-2020 — INBONE STEM, TIBIAL, TOP, Part Number 200011901
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051023.
Data sourced from openFDA. This site is unofficial and independent of the FDA.