510(k) · Cleared
ClearedTIDAL Fusion Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restor3D, Inc. · SAI Ankle Fusion Cage
Cleared on Mar 24, 2025 as substantially equivalent to K171376 (MedShape, Inc., 2017) and 1 other predicate after a 228-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Mar 24, 2025
- Review
- 228 days
- Class
- Class II
- Product code
- SAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K951740 (1995). 38 ancestors in all, the oldest K923580 (1993). No later device cites it as a predicate yet.
- Root · 8 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 7 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 6 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- 5 generations backK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- 4 generations backK111667 Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · Recalled
- 3 generations backK131365 T2 Tibial Nailing SystemStryker Trauma AG · 2013 · Recalled
- 2 generations backK200880 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar…Stryker GmbH · 2020
- 1 generation backK230088 Ankle Truss System (ATS)4Web Medical, Inc. · 2024
- This deviceK242356 TIDAL Fusion Cage SystemRestor3D, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −7 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −6 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| −5 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| −4 | K111667 | Synthes Suprapatellar Insertion Instruments | Synthes (Usa) | 2011 | 1 |
| −3 | K131365 | T2 Tibial Nailing System | Stryker Trauma AG | 2013 | 4 |
| −2 | K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail… | Stryker GmbH | 2020 | — |
| −1 | K230088 | Ankle Truss System (ATS) | 4Web Medical, Inc. | 2024 | — |
| 0 (this device) | 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 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 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 K230088 Ankle Truss System (ATS)score 11.8 · 7 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 |
|---|---|---|---|
| * | K171376 | DynaNail TTC Fusion SystemSummary page 5…equivalent to the following devices: 510(k) Trade Name Manufacturer Primary Predicate Device K171376 DynaNail TTC Fusion System MedShape Secondary Predicate Device K230088… | 2017 |
| * | K230088 | Ankle Truss System (ATS)Summary page 5…er Primary Predicate Device K171376 DynaNail TTC Fusion System MedShape Secondary Predicate Device K230088 4WEB Medical Ankle Truss System (ATS) 4WEB Reference Predicate Device K201314 rest… | 2024 |
| † | K201314 | Restor3d Utility Wedge | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 7 companies; a new generation was cleared every 3.7 years on median.
- 20 of the 38 ancestors have a recall of any class.
- 6 other devices also cite its predicate K171376.
How does its category compare?
All SAI devicesSAI Ankle Fusion Cage: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 TIDAL Fusion Cage System is intended to be used as part of a tibiotalocalcaneal fusion construct in a salvage procedure following failed ankle arthrodesis or failed ankle arthroplasty for patients at risk of limb loss. The TIDAL Fusion Cage System is intended for use as an accessory to the DynaNail TTC Fusion System. The TIDAL Fusion Cage System is not intended for standalone use. The TIDAL Fusion Cage System is intended for use with autograft and/or allogenic bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242356: TIDAL Fusion Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242356
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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