510(k) · Cleared
ClearedTreace Medical Concepts (TMC) Implant Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Treace Medical Concepts · JDR Staple, Fixation, Bone
Cleared on Nov 21, 2022 as substantially equivalent to K121277 (Z-Medical GmbH & Co. KG, 2012) and 1 other predicate after an 81-day review. Its family tree reaches back 5 generations to 1990. 6 later devices descend from it.
- Decided
- Nov 21, 2022
- Review
- 81 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K902307 (1990). 18 ancestors in all, the oldest K894929 (1989). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 4 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 3 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
- 2 generations backK124045 Fuseforce Implant SystemSolana Surgical, LLC · 2013
- 1 generation backK203832 FuseForce™ Flex Dynamic Compression SystemWright Medical · 2021 · Recalled
- This deviceK222645 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2022
- Descendant · cites it directly · 4 of its ownK232387 Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts · 2023
- Descendant · 2 generations on · 3 of its ownK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
- Descendant · 3 generations on · 2 of its ownK243658 TMC Compression Implant SystemTreace Medical Concepts · 2024
- Descendant · 4 generations on · 1 of its ownK251135 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025
- Descendant · 5 generations on · 0 of its ownK262963 TMC Implant Fixation SystemTreace Medical Concepts, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts · 2023 · cites it directly4descendants
- K242415TMC Compression Implant SystemTreace Medical Concepts · 2024 · 2 generations on3descendants
- K243658TMC Compression Implant SystemTreace Medical Concepts · 2024 · 3 generations on2descendants
- K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025 · 4 generations on1descendant
- K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −4 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −3 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| −2 | K124045 | Fuseforce Implant System | Solana Surgical, LLC | 2013 | — |
| −1 | K203832 | FuseForce™ Flex Dynamic Compression System | Wright Medical | 2021 | 1 |
| 0 (this device) | K222645 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2022 | — |
| +1 | K232387 | Treace Medical Concepts (TMC) Compression Implant System | Treace Medical Concepts | 2023 | — |
| +2 | K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +3 | K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +4 | K251135 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2025 | — |
| +5 | K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 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 JDR? 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 JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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 |
|---|---|---|---|
| * | K121277 | Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleSummary page 5…87- Orthopedic Product Code(s): JDR Staple, Fixation, Bone Predicate Device(s): Primary Predicate: • Z-Medical Z-Staple (K121277, S.E. 11/07/2012) Additional Predicate: • Wright Medical FuseForce™ Flex Dynamic Compression System (K203832, S.E. 05… | 2012 |
| * | K203832 | FuseForce™ Flex Dynamic Compression SystemSummary page 5…evice(s): Primary Predicate: • Z-Medical Z-Staple (K121277, S.E. 11/07/2012) Additional Predicate: • Wright Medical FuseForce™ Flex Dynamic Compression System (K203832, S.E. 05/07/2021) Reference Device: • Treace Medical Concepts (TMC) Plating System (K220136, S.E. 02/16/2022) Device… | 2021 |
| † | K220136 | Treace Medical Concepts (TMC) Plating System | 2022 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 6 companies; a new generation was cleared every 7.1 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K232387 (Treace Medical Concepts, 2023) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K121277.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222645: Treace Medical Concepts (TMC) Implant Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222645
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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