# K051023: Topez Total Ankle Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Topez Orthopedics, Inc.
- Decided: Nov 15, 2005 after 207 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920802 (1992). 2 ancestors in all.
64 later devices descend from it; 9 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020541: Agility Ankle Revision Prosthesis, Depuy, Inc. (2002) Summary page 3.

## Most influential descendants
- K100886: Inbone II Total Ankle Replacement (2010), 56 descendants of its own
- K123954: Infinity Total Ankle System (2013), 52 descendants of its own
- K140749: Infinity Total Ankle System (2014), 48 descendants of its own
- K133585: Inbone Total Ankle (2014), 34 descendants of its own
- K153008: INVISION Total Ankle Revision System (2016), 29 descendants of its own

## Recalls of this device
- Sep 30, 2022 · Class II · Z-0140-2023: The tibial tray lock detail is oversized (larger than specification).
- Sep 30, 2022 · Class II · Z-0139-2023: The tibial tray lock detail is oversized (larger than specification).
- Apr 9, 2020 · Class II · Z-1924-2020: One lot of INBONE Tibial Trays is missing the plasma coating.
- Nov 8, 2016 · Class II · Z-0565-2020: The firm discovered a lack of adequate documentation confirming sterility on certain products.

## Indications for use
Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic or degenerative arthritis. The ankle prosthesis is additionally indicated for patients with a failed previous ankle surgery. CAUTION: The ankle prosthesis is intended for cemented use only.

Source page: https://510kreport.com/device/K051023
Methodology: https://510kreport.com/methodology