510(k) · Cleared
ClearedTTC Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deal, S.A. · HRS Plate, Fixation, Bone
Cleared on May 17, 2006 as substantially equivalent to K022255 (Synthes (Usa), 2002) and 1 other predicate after an 83-day review. Its family tree reaches back 2 generations to 2002. 76 later devices descend from it.
- Decided
- May 17, 2006
- Review
- 83 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K013415 (2002). 3 ancestors in all, the oldest K010321 (2001). 76 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK013415 Synthes Ankle Arthrodesis PlateSynthes (Usa) · 2002
- 1 generation backK022255 Modofocation to Synthes Ankle Arthrodesis PlatesSynthes (Usa) · 2002
- This deviceK060473 TTC PlateNew Deal, S.A. · 2006
- Descendant · cites it directly · 73 of its ownK073375 Newdeal Tibiaxys SystemNewdeal Sas · 2008 · Recalled
- Descendant · cites it directly · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- Descendant · cites it directly · 56 of its ownK100176 Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010
- Descendant · cites it directly · 54 of its ownK090139 Ankle Arthrodesis Plate SystemTornier, Inc. · 2009
- Descendant · cites it directly · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K073375Newdeal Tibiaxys SystemNewdeal Sas · 2008 · cites it directly73descendants
- K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · cites it directly69descendants
- K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010 · cites it directly56descendants
- K090139Ankle Arthrodesis Plate SystemTornier, Inc. · 2009 · cites it directly54descendants
- K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · cites it directly53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013415 | Synthes Ankle Arthrodesis Plate | Synthes (Usa) | 2002 | — |
| −1 | K022255 | Modofocation to Synthes Ankle Arthrodesis Plates | Synthes (Usa) | 2002 | — |
| 0 (this device) | K060473 | TTC Plate | New Deal, S.A. | 2006 | — |
| +1 | K073375 | Newdeal Tibiaxys System | Newdeal Sas | 2008 | 2 |
| +1 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| +1 | K100176 | Ascension Ankle Fusion Plate System | Ascension Orthopedics, Inc. | 2010 | — |
| +1 | K090139 | Ankle Arthrodesis Plate System | Tornier, Inc. | 2009 | — |
| +1 | K121425 | Ortholoc 3DI Ankle Fusion Plating System | Wrightmedicaltechnologyinc | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 10 | 0 |
| 2022 | 2 | 0 |
| 2023 | 10 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 8 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K022255 | Modofocation to Synthes Ankle Arthrodesis PlatesSummary page 1…e: HRS Classification Panel: Orthopedic Substantial Equivalence: The TTC Plate is substantially equivalent to the Synthes Ankle Arthrodesis Plates, K022255 and the Syntbes Modular Foot System - 2.7 mm Module, K010321. Device Description: The NEWDEAL® TTC Plates consists of a pl… | 2002 |
| * | K010321 | Modular Foot System - 2.7 MM ModuleSummary page 1…quivalence: The TTC Plate is substantially equivalent to the Synthes Ankle Arthrodesis Plates, K022255 and the Syntbes Modular Foot System - 2.7 mm Module, K010321. Device Description: The NEWDEAL® TTC Plates consists of a plate, available in different sizes, and implanted using… | 2001 |
What descends from it? (76)
See all 766 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073375 | Newdeal Tibiaxys System | 2008 | 73 |
| K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws… | 2011 | 69 |
| K100176 | Ascension Ankle Fusion Plate System | 2010 | 56 |
| K090139 | Ankle Arthrodesis Plate System | 2009 | 54 |
| K121425 | Ortholoc 3DI Ankle Fusion Plating System | 2012 | 53 |
| K070160 | Modification to TTC Plates | 2007 | 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 4 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073375 (Newdeal Sas, 2008) has gone furthest, with 73 descendants of its own.
- 3 other devices also cite its predicate K022255.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The NEWDEAL ® TTC Plates are intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones in the foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060473 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060473: TTC Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060473
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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