510(k) · Cleared
Recalled · Class II · 2018T2 Ankle Arthrodesis Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 29, 2005 after a 44-day review. The FDA summary names no predicate by number. 33 later devices descend from it. It has been recalled 8 times.
- Decided
- Jul 29, 2005
- Review
- 44 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 8
- Predicates
- 0
33 later devices descend from it, 10 citing it directly.
- This deviceK051590 T2 Ankle Arthrodesis NailHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 11 of its ownK200880 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar…Stryker GmbH · 2020
- Descendant · cites it directly · 11 of its ownK112982 Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Small Bone Innovations, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK130147 Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc. · 2013
- Descendant · cites it directly · 9 of its ownK120419 Dyna Locking Ankle NailU&I Corp. · 2012
- Descendant · 2 generations on · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH · 2020 · cites it directly11descendants
- K112982Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Small Bone Innovations, Inc. · 2012 · cites it directly11descendants
- K130147Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc. · 2013 · 2 generations on9descendants
- K120419Dyna Locking Ankle NailU&I Corp. · 2012 · cites it directly9descendants
- K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051590 | T2 Ankle Arthrodesis Nail | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail… | Stryker GmbH | 2020 | — |
| +1 | K112982 | Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail ) | Small Bone Innovations, Inc. | 2012 | — |
| +2 | K130147 | Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail) | Small Bone Innovations, Inc. | 2013 | — |
| +1 | K120419 | Dyna Locking Ankle Nail | U&I Corp. | 2012 | — |
| +2 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary… | Paragon 28, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 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?
The FDA summary names no predicate by number.
What descends from it? (33)
See all 3310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon… | 2020 | 11 |
| K112982 | Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail ) | 2012 | 11 |
| K120419 | Dyna Locking Ankle Nail | 2012 | 9 |
| K102413 | Fuze: Intramedullary Internal Fixation Nail | 2011 | 7 |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | 2018 | 1 |
| K121575 | Oxford Ankle Fusion Nail (Afn) System | 2012 | 1 |
| K100925 | Ascension Ankle Fusion Nail System | 2010 | 1 |
| K163589 | SIGN IM Nail | 2017 | 0 |
| K130051 | 611 Ankle Fusion Nail | 2013 | 0 |
| K102577 | Force Medical IM Nail System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2018 | Class II | Z-2884-2018 | Packaging process control | Incomplete seal on the Tyvek lid may compromise the sterility of the device |
| Dec 29, 2009 | Not classified | Z-0841-2010 | Packaging | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. |
| Dec 29, 2009 | Not classified | Z-0842-2010 | Packaging | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. |
| Dec 29, 2009 | Not classified | Z-0846-2010 | Packaging | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. |
| Dec 29, 2009 | Not classified | Z-0843-2010 | Packaging | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. |
| Dec 29, 2009 | Not classified | Z-0844-2010 | Packaging | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. |
| Dec 29, 2009 | Not classified | Z-0845-2010 | Packaging | Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport. |
| Nov 17, 2006 | Not classified | Z-1818-2009 | Labeling Change Control | Operative Surgical Technique was found to have a typographical error where hyphens were inadvertently omitted in incision lengths (i.e. 1520 cm should be 15-20 cm). |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K200880 (Stryker GmbH, 2020) has gone furthest, with 11 descendants of its own.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The T2" Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: Post-traumatic or primary Arthrosis Previously infected arthrosis (second degree) Revision of Failed Ankle Arthrodesis Failed Total Ankle Replacement Avascular Necrosis of the Talus (requiring…
Read the full statement (113 words)
The T2" Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
Post-traumatic or primary Arthrosis
Previously infected arthrosis (second degree)
Revision of Failed Ankle Arthrodesis
Failed Total Ankle Replacement
Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis)
Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle
Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot
Ostheoartritis
Nonunions or Pseudarthrosis of hindfoot and distal tibia
Malunited tibial pilon fracture
Charcot foot
Severe endstage degenerative arthritis
Severe defects after tumor resection
Pantalar arthrodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051590: T2 Ankle Arthrodesis Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051590
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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