510(k) · Cleared
ClearedAnkle Truss System (ATS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
4Web Medical, Inc. · SAI Ankle Fusion Cage
Cleared on Mar 21, 2024 as substantially equivalent to K090857 (Wrightmedicaltechnologyinc, 2009) and 1 other predicate after a 434-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- Mar 21, 2024
- Review
- 434 days
- Class
- Class II
- Product code
- SAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K951740 (1995). 29 ancestors in all, the oldest K923580 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 6 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 5 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- 4 generations backK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- 3 generations backK111667 Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · Recalled
- 2 generations backK131365 T2 Tibial Nailing SystemStryker Trauma AG · 2013 · Recalled
- 1 generation backK200880 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar…Stryker GmbH · 2020
- This deviceK230088 Ankle Truss System (ATS)4Web Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK242356 TIDAL Fusion Cage SystemRestor3D, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242356TIDAL Fusion Cage SystemRestor3D, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −6 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −5 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| −4 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| −3 | K111667 | Synthes Suprapatellar Insertion Instruments | Synthes (Usa) | 2011 | 1 |
| −2 | K131365 | T2 Tibial Nailing System | Stryker Trauma AG | 2013 | 4 |
| −1 | K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail… | Stryker GmbH | 2020 | — |
| 0 (this device) | K230088 | Ankle Truss System (ATS) | 4Web Medical, Inc. | 2024 | — |
| +1 | K242356 | TIDAL Fusion Cage System | Restor3D, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
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 SAI? 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 SAI device
- #1 K242356 TIDAL Fusion Cage Systemscore 11.2 · 8 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K090857 | Valor Ankle Fusion Nail SystemSummary page 4…ary and Accessories Product Code: SAI Secondary Product Code: HSB Predicate Device(s): The primary predicate device is the Stryker Valor Hindfoot Fusion Nail (K090857). An additional predicate is the Stryker T2 Ankle Arthrodesis Nail (K200880). A reference device is the 4WEB Medical Lateral Spin… | 2009 |
| * | K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Summary page 4…Predicate Device(s): The primary predicate device is the Stryker Valor Hindfoot Fusion Nail (K090857). An additional predicate is the Stryker T2 Ankle Arthrodesis Nail (K200880). A reference device is the 4WEB Medical Lateral Spine Truss System – Interbody Fusion Device (K211388). Device Description: The… | 2020 |
| † | K211388 | Lateral Spine Truss System (LSTS) Interbody Fusion Device | 2021 |
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 |
|---|---|---|---|
| K242356 | TIDAL Fusion Cage System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- 19 of the 29 ancestors have a recall of any class.
- Of its descendants, K242356 (Restor3D, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K090857.
How does its category compare?
All SAI devicesSAI Ankle Fusion Cage: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SAI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SAI
Too few SAI 510(k)s in any year since 2007 to give a median.
Recalls per year · SAI
No recall names SAI since 2007.
Adverse event reports per year · SAI
No MAUDE report names SAI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 4WEB Medical Ankle Truss System (ATS) is for use as an accessory to the Stryker T2 Ankle Arthrodesis Nail or the Stryker Valor Hindfoot Fusion Nail as part of a tibiotalocalcaneal fusion construct in a salvage procedure following failed ankle arthrodesis or failed ankle arthroplasty for patients at risk for loss of limb. The ATS is not intended for standalone use.
The anatomical landmarks necessary for the design and creation of ATS devices that are patient matched must be present and identifiable on appropriate radiography scans. The ATS is intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230088: Ankle Truss System (ATS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230088
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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