510(k) · Cleared
ClearedPROSTEP™ TBI™ (Tailors Bunion Implant) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HWC Screw, Fixation, Bone
Cleared on Aug 13, 2019 as substantially equivalent to K082320 (Wrightmedicaltechnologyinc, 2008) and 2 other predicates after a 123-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Aug 13, 2019
- Review
- 123 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K960385 (1996). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 4 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 3 generations backK101165 Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc · 2010
- 2 generations backK120645 Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc · 2012
- 1 generation backK132895 WMT Implantable K-WireWrightmedicaltechnologyinc · 2013
- This deviceK190970 PROSTEP™ TBI™ (Tailors Bunion Implant) SystemWrightmedicaltechnologyinc · 2019
- Descendant · cites it directly · 0 of its ownK262963 TMC Implant Fixation SystemTreace Medical Concepts, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −4 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −3 | K101165 | Pro-Toe VO Hammertow Implant System | Wrightmedicaltechnologyinc | 2010 | — |
| −2 | K120645 | Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition | Wrightmedicaltechnologyinc | 2012 | — |
| −1 | K132895 | WMT Implantable K-Wire | Wrightmedicaltechnologyinc | 2013 | — |
| 0 (this device) | K190970 | PROSTEP™ TBI™ (Tailors Bunion Implant) System | Wrightmedicaltechnologyinc | 2019 | — |
| +1 | K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K082320 | Darco Small ScrewSummary page 4…e & Panel: HRS / HWC – Orthopedic (a)(3) PREDICATE DEVICE INFORMATION Wright Compression Screw System (primary) K082320 WMT Implantable K-Wires (secondary) K132895 ORTHOLOC® 3Di Small Bones Plating Sys… | 2008 |
| * | K132895 | WMT Implantable K-WireSummary page 4…ORMATION Wright Compression Screw System (primary) K082320 WMT Implantable K-Wires (secondary) K132895 ORTHOLOC® 3Di Small Bones Plating System (secondary) K163039… | 2013 |
| * | K163039 | ORTHOLOC® 3Di Small Bones PlatingSummary page 4…K082320 WMT Implantable K-Wires (secondary) K132895 ORTHOLOC® 3Di Small Bones Plating System (secondary) K163039 K190970 Page 2 of 2 (a)(4) DE… | 2017 |
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 |
|---|---|---|---|
| K262963 | TMC Implant Fixation System | 2026 | 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 23 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K262963 (Treace Medical Concepts, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 17 other devices also cite its predicate K082320.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The PROSTEP™ TBI™ (Tailor’s Bunion Implant) system is indicated for the fixation of 5th metatarsal osteotomies made in the correction of Tailor’s Bunion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190970 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190970: PROSTEP™ TBI™ (Tailors Bunion Implant) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190970
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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