510(k) · Cleared
Recalled · Class II · 2022Topez Total Ankle Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topez Orthopedics, Inc. · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Nov 15, 2005 as substantially equivalent to K020541 (Depuy, Inc., 2002) after a 207-day review. Its family tree reaches back 2 generations to 1992. 64 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 15, 2005
- Review
- 207 days
- Class
- Class II
- Product code
- HSN
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920802 (1992). 64 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 1 generation backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- This deviceK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005
- Descendant · cites it directly · 56 of its ownK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- Descendant · cites it directly · 52 of its ownK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- Descendant · 2 generations on · 48 of its ownK140749 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · Recalled
- Descendant · 2 generations on · 34 of its ownK133585 Inbone Total AnkleWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 29 of its ownK153008 INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K100886Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · cites it directly56descendants
- K123954Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · cites it directly52descendants
- K140749Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2014 · 2 generations on48descendants
- K133585Inbone Total AnkleWrightmedicaltechnologyinc · 2014 · 2 generations on34descendants
- K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc · 2016 · cites it directly29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −1 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| 0 (this device) | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | — |
| +1 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| +1 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| +2 | K140749 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2014 | 1 |
| +2 | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K153008 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 9 | 0 |
| 2024 | 12 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSN device
- #1 K192994 Paragon 28 APEX 3D Total Ankle Replacement…score 16.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020541 | Agility Ankle Revision ProsthesisSummary page 3…Page 3 of S Device: Ankle Prosthesis Common Name: Ankle prothesis SE Predicate: DePuy Inc. Agility Ankle K020541 888.3110 Device Description: Summary: The Topez prosthesis is a total ankle joint replacement medical device. It… | 2002 |
What descends from it? (64)
See all 649 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100886 | Inbone II Total Ankle Replacement | 2010 | 56 |
| K123954 | Infinity Total Ankle System | 2013 | 52 |
| K153008 | INVISION Total Ankle Revision System | 2016 | 29 |
| K060544 | Salto Talaris Total Ankle Prosthesis | 2006 | 23 |
| K123059 | Inbone ( I and II) Total Ankle Systems | 2013 | 21 |
| K090076 | Salto Talaris Total Ankle Prosthesis | 2009 | 21 |
| K110360 | Prophecy Inbone Pre-Operative Navigation Alignment Guides | 2011 | 19 |
| K130533 | Salto Talaris Total Ankle Prosthesis, RHS | 2013 | 16 |
| K171004 | Hintermann Series H2 Total Ankle System | 2017 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2022 | Class II | Z-0140-2023 | Device Design | The tibial tray lock detail is oversized (larger than specification). |
| Sep 30, 2022 | Class II | Z-0139-2023 | Device Design | The tibial tray lock detail is oversized (larger than specification). |
| Apr 9, 2020 | Class II | Z-1924-2020 | Nonconforming Material/Component | One lot of INBONE Tibial Trays is missing the plasma coating. |
| Nov 8, 2016 | Class II | Z-0565-2020 | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K100886 (Wrightmedicaltechnologyinc, 2010) has gone furthest, with 56 descendants of its own.
- 5 other devices also cite its predicate K020541.
How does its category compare?
All HSN devicesHSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSN
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSN
1,645in 2025
MAUDE reports naming product code HSN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 50 |
| 2008 | 0 | — | 0 | 66 |
| 2009 | 1 | — | 0 | 66 |
| 2010 | 2 | — | 0 | 120 |
| 2011 | 1 | — | 0 | 139 |
| 2012 | 2 | — | 0 | 100 |
| 2013 | 4 | 89 | 3 | 106 |
| 2014 | 2 | — | 0 | 65 |
| 2015 | 3 | 233 | 0 | 73 |
| 2016 | 3 | 216 | 1 | 111 |
| 2017 | 4 | 148 | 2 | 96 |
| 2018 | 4 | 89 | 0 | 187 |
| 2019 | 2 | — | 1 | 277 |
| 2020 | 6 | 234 | 0 | 281 |
| 2021 | 4 | 109 | 3 | 237 |
| 2022 | 1 | — | 2 | 453 |
| 2023 | 6 | 112 | 1 | 796 |
| 2024 | 7 | 115 | 0 | 1,095 |
| 2025 | 3 | 58 | 0 | 1,645 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051023 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051023: Topez Total Ankle Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051023
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026