510(k) · Cleared
Recalled · Class II · 2024Treace Medical Systems (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 Feb 22, 2024 as substantially equivalent to K221181 (Treace Medical Concepts, Inc., 2023) and 3 other predicates after a 30-day review. Its family tree reaches back 16 generations to 1996. 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 22, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 16 generations to K954385 (1996). 247 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 12 generations between
- 3 generations backK200961 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2020
- 2 generations backK220136 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2022
- 1 generation backK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
- This deviceK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024
- Descendant · cites it directly · 3 of its ownK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
- Descendant · 2 generations on · 2 of its ownK243658 TMC Compression Implant SystemTreace Medical Concepts · 2024
- Descendant · cites it directly · 1 of its ownK251135 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025
- Descendant · 2 generations on · 0 of its ownK262963 TMC Implant Fixation SystemTreace Medical Concepts, Inc. · 2026
Show all 16 generations
- Root · 16 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 15 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 14 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 13 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 12 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 11 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 10 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 9 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 8 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 7 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 6 generations backK143717 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2015
- 5 generations backK153531 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2016
- 4 generations backK192504 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2019
- 3 generations backK200961 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2020
- 2 generations backK220136 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2022
- 1 generation backK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
- This deviceK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K242415TMC Compression Implant SystemTreace Medical Concepts · 2024 · cites it directly3descendants
- K243658TMC Compression Implant SystemTreace Medical Concepts · 2024 · 2 generations on2descendants
- K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025 · cites it directly1descendant
- K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −15 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −14 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −13 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −12 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −11 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −10 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −9 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −8 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −7 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −6 | K143717 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2015 | — |
| −5 | K153531 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2016 | — |
| −4 | K192504 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2019 | — |
| −3 | K200961 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2020 | — |
| −2 | K220136 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2022 | — |
| −1 | K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2023 | — |
| 0 (this device) | K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024 | — |
| +1 | K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +2 | K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +1 | K251135 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2025 | — |
| +2 | 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 | 4 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 16 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 11 | 0 |
| 2000 | 13 | 0 |
| 2001 | 16 | 0 |
| 2002 | 14 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 18 | 0 |
| 2006 | 19 | 0 |
| 2007 | 14 | 0 |
| 2008 | 9 | 0 |
| 2009 | 12 | 0 |
| 2010 | 10 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 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? (4)
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 |
|---|---|---|---|
| * | K221181 | Treace Medical Concepts (TMC) Plating SystemSummary page 4…87- Orthopedic Product Code(s): HRS, HWC Predicate Device(s): • Primary Predicate: Treace Medical Concepts (TMC) Plating System (K221181, S.E. 01/05/2023) • Additional Predicate(s): o Treace Medical Concepts (TMC) Screw Fixation System (… | 2023 |
| * | K213036 | Treace Medical Concepts (TMC) Screw Fixation SystemSummary page 4…l Concepts (TMC) Plating System (K221181, S.E. 01/05/2023) • Additional Predicate(s): o Treace Medical Concepts (TMC) Screw Fixation System (K213036, S.E.10/21/2021) o CrossRoads Extremity Systems LLC., MIS Bunion System (K181872, S.E. 02/19/2019)… | 2021 |
| * | K181872 | MIS Bunion SystemSummary page 4…Treace Medical Concepts (TMC) Screw Fixation System (K213036, S.E.10/21/2021) o CrossRoads Extremity Systems LLC., MIS Bunion System (K181872, S.E. 02/19/2019) o OrthoHelix Surgical Designs Inc., Mini MaxLock Extreme Plating System (K101962, S.E. 0… | 2019 |
| * | K101962 | Mini Maxlock Extreme Plating SystemSummary page 4…y Systems LLC., MIS Bunion System (K181872, S.E. 02/19/2019) o OrthoHelix Surgical Designs Inc., Mini MaxLock Extreme Plating System (K101962, S.E. 09/27/2010) Device Description: The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, H- shaped, a… | 2010 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 2, 2024 | Class II | Z-2718-2024 | Under Investigation by firm | Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 48 of the 247 ancestors have a recall of any class.
- Of its descendants, K242415 (Treace Medical Concepts, 2024) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K221181.
How does its category compare?
All HRS devicesHRS Plate, 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 · 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 the feet. The system can be used in both pediatric (aged >12-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples: * Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as: - Opening base wedge osteotomy - Closing base…
Read the full statement (175 words)
The TMC Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The system can be used in both pediatric (aged >12-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples:
* Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:
- Opening base wedge osteotomy
- Closing base wedge osteotomy
- Crescentic osteotomy
- Proximal Chevron osteotomy
- Distal Chevron osteotomy (Austin)
- Transverse osteotomy
* Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis
* First metatarsal fracture fixation
* 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
- Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cuboid (CC) Fusion
* Medial Column Fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240173: Treace Medical Systems (TMC) Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240173
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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