510(k) · Cleared
ClearedTreace Medical Concepts (TMC) Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Treace Medical Concepts, Inc. · HRS Plate, Fixation, Bone
Cleared on Jan 7, 2016 as substantially equivalent to K143717 (Treace Medical Concepts, Inc., 2015) after a 29-day review. Its family tree reaches back 11 generations to 1996. 11 later devices descend from it.
- Decided
- Jan 7, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K954385 (1996). 54 ancestors in all, the oldest K895117 (1990). 11 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 2 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 1 generation backK143717 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2015
- This deviceK153531 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2016
- Descendant · cites it directly · 10 of its ownK192504 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2019
- Descendant · 2 generations on · 9 of its ownK200961 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2020
- Descendant · cites it directly · 8 of its ownK220136 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2022
- Descendant · 2 generations on · 7 of its ownK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
- Descendant · 3 generations on · 4 of its ownK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · Recalled
Show all 11 generations
- Root · 11 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 10 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 9 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 8 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 7 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 6 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 5 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 4 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 3 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 2 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 1 generation backK143717 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2015
- This deviceK153531 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2019 · cites it directly10descendants
- K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2020 · 2 generations on9descendants
- K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2022 · cites it directly8descendants
- K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023 · 2 generations on7descendants
- K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −10 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −9 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −8 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −7 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −6 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −5 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −4 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −3 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −2 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −1 | K143717 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2015 | — |
| 0 (this device) | K153531 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2016 | — |
| +1 | K192504 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2019 | — |
| +2 | K200961 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2020 | — |
| +1 | 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 | — |
| +3 | K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K143717 | Treace Medical Concepts (TMC) Plating SystemSummary page 6…ct to indications for use, design, dimension, and materials to the following device, previously cleared by the FDA: Treace Medical Concepts (TMC) Plating System (K143717) As indicated above, there are insignificant differences between the subject and predicate devices. The PYTHONTM plate does not… | 2015 |
What descends from it? (11)
See all 112 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 20 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 15 of the 54 ancestors have a recall of any class.
- Of its descendants, K192504 (Treace Medical Concepts, Inc., 2019) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K143717.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 TMC Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. In the foot, the system can be used for the following specific examples: -- First metatarsal osteotomies for hallux valgus correction such as: • Opening base wedge osteotomy • Closing base wedge osteotomy • Crescentic osteotomy • Proximal Chevron osteotomy • Distal Chevron osteotomy (Austin) --…
Read the full statement (153 words)
The TMC Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. In the foot, the system can be used for the following specific examples:
-- First metatarsal osteotomies for hallux valgus correction such as:
• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Crescentic osteotomy
• Proximal Chevron osteotomy
• Distal Chevron osteotomy (Austin)
-- First metatarsal fracture fixation
-- Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
-- Flatfoot Osteotomies
• Lateral Column Lengthening (Evans Osteotomy)
• Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
-- Mid / Flatfoot Fusions
• LisFranc Arthrodesis and/or Stabilization
• 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• lntercuneiform Fusions
• Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• Calcaneo-Cuboid (CC) Fusion
-- Medial Column Fusion
-- Arthrodesis of the first metatarsophalangeal joint (MTP)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153531 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153531: Treace Medical Concepts (TMC) Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153531
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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