510(k) · Cleared
ClearedTMC Compression Implant 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 Sep 6, 2024 as substantially equivalent to K232387 (Treace Medical Concepts, 2023) and 2 other predicates after a 22-day review. Its family tree reaches back 17 generations to 1996. 3 later devices descend from it.
- Decided
- Sep 6, 2024
- Review
- 22 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K954385 (1996). 261 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 13 generations between
- 3 generations backK220136 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2022
- 2 generations backK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
- 1 generation backK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · Recalled
- This deviceK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
- Descendant · cites it directly · 2 of its ownK243658 TMC Compression Implant SystemTreace Medical Concepts · 2024
- Descendant · 2 generations on · 1 of its ownK251135 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025
- Descendant · 3 generations on · 0 of its ownK262963 TMC Implant Fixation SystemTreace Medical Concepts, Inc. · 2026
Show all 17 generations
- Root · 17 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 16 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 15 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 14 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 13 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 12 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 11 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 10 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 9 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 8 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 7 generations backK143717 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2015
- 6 generations backK153531 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2016
- 5 generations backK192504 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2019
- 4 generations backK200961 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2020
- 3 generations backK220136 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2022
- 2 generations backK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
- 1 generation backK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · Recalled
- This deviceK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
Most influential descendants
Showing 3 of 3 · See all- K243658TMC Compression Implant SystemTreace Medical Concepts · 2024 · cites it directly2descendants
- K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025 · 2 generations on1descendant
- K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −16 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −15 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −14 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −13 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −12 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −11 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −10 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −9 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −8 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −7 | K143717 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2015 | — |
| −6 | K153531 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2016 | — |
| −5 | K192504 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2019 | — |
| −4 | K200961 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2020 | — |
| −3 | K220136 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2022 | — |
| −2 | K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2023 | — |
| −1 | K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024 | 1 |
| 0 (this device) | K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +1 | K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +2 | K251135 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2025 | — |
| +3 | K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 18 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 11 | 0 |
| 2000 | 13 | 0 |
| 2001 | 16 | 0 |
| 2002 | 14 | 0 |
| 2003 | 9 | 0 |
| 2004 | 7 | 0 |
| 2005 | 18 | 0 |
| 2006 | 19 | 0 |
| 2007 | 15 | 0 |
| 2008 | 9 | 0 |
| 2009 | 13 | 0 |
| 2010 | 11 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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? (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 |
|---|---|---|---|
| * | K232387 | Treace Medical Concepts (TMC) Compression Implant SystemSummary page 5…t Code(s): Primary: JDR Subsequent: HWC Predicate Device(s): • Primary Predicate: TMC Compression Implant System (K232387, S.E. 08/28/2023) • Additional Predicate: TMC Plating System (K240173, S.E. 02/22/2024) • Additional Predicate: Restore… | 2023 |
| * | K240173 | Treace Medical Systems (TMC) Plating SystemSummary page 5…sequent: HWC Predicate Device(s): • Primary Predicate: TMC Compression Implant System (K232387, S.E. 08/28/2023) • Additional Predicate: TMC Plating System (K240173, S.E. 02/22/2024) • Additional Predicate: Restore Bunion Correction System (K131061, S.E. 08/28/2013) Device Description:… | 2024 |
| * | K131061 | Restore Bunion Correction SystemSummary page 5…stem (K232387, S.E. 08/28/2023) • Additional Predicate: TMC Plating System (K240173, S.E. 02/22/2024) • Additional Predicate: Restore Bunion Correction System (K131061, S.E. 08/28/2013) Device Description: TMC Compression Implant System is comprised of staple implants and related instrumentati… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243658 | TMC Compression Implant System | 2024 | 2 |
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 28 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 50 of the 261 ancestors have a recall of any class.
- Of its descendants, K243658 (Treace Medical Concepts, 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242415 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242415: TMC Compression Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242415
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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