510(k) · Cleared
Recalled · Class II · 2019Zimmer Trabecular Metal Total Ankle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Aug 24, 2012 as substantially equivalent to K920802 (Depuy, Inc., 1992) and 2 other predicates after a 151-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Aug 24, 2012
- Review
- 151 days
- Class
- Class II
- Product code
- HSN
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 4 generations to K920802 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 3 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 2 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 1 generation backK060544 Salto Talaris Total Ankle ProsthesisTornier · 2006 · Recalled
- This deviceK120906 Zimmer Trabecular Metal Total AnkleZimmer, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK250641 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −3 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −2 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −1 | K060544 | Salto Talaris Total Ankle Prosthesis | Tornier | 2006 | 18 |
| 0 (this device) | K120906 | Zimmer Trabecular Metal Total Ankle | Zimmer, Inc. | 2012 | — |
| +1 | K250641 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K920802 | Alvine Total AnkleSummary page 1…Alvine Total Ankle Prosthesis (Agility), manufactured by Depuy Orthopaedics, Inc., K920802, cleared December 17, 1992 and K020541, cleared May 20, 2002..… | 1992 |
| * | K020541 | Agility Ankle Revision ProsthesisSummary page 1…manufactured by Depuy Orthopaedics, Inc., K920802, cleared December 17, 1992 and K020541, cleared May 20, 2002.. Salto Talaris Total Ankle Prosthesis, manufactured… | 2002 |
| * | K060544 | Salto Talaris Total Ankle ProsthesisSummary page 1…red May 20, 2002.. Salto Talaris Total Ankle Prosthesis, manufactured by Tomier Inc., K060544, cleared November 13, 2006. Device Description: The Zim'mer Trab… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250641 | APEX 3D Total Ankle Replacement System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0306-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Nov 12, 2013 | Class II | Z-0477-2014 | Manufacturing material removal | As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on… |
| Nov 12, 2013 | Class II | Z-0475-2014 | Manufacturing material removal | As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on… |
| Nov 12, 2013 | Class II | Z-0476-2014 | Manufacturing material removal | As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K250641 (Paragon 28, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K920802.
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. 2012, this device’s year, is highlighted.
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 provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.
The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with:
* Rheumatoid arthritis.
* Post-traumatic arthritis.
* Degenerative arthritis.
This device is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120906 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120906: Zimmer Trabecular Metal Total Ankle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120906
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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