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 5, 2023 as substantially equivalent to K220136 (Treace Medical Concepts, Inc., 2022) and 2 other predicates after a 255-day review. Its family tree reaches back 15 generations to 1996. 7 later devices descend from it.
- Decided
- Jan 5, 2023
- Review
- 255 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K954385 (1996). 98 ancestors in all, the oldest K792670 (1980). 7 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK192504 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2019
- 2 generations backK200961 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2020
- 1 generation backK220136 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2022
- This deviceK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
- Descendant · cites it directly · 4 of its ownK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · Recalled
- 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 · 2 generations on · 1 of its ownK251135 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025
- Descendant · cites it directly · 1 of its ownK233154 SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC · 2023
Show all 15 generations
- Root · 15 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 14 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 13 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 12 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 11 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 10 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 9 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 8 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 7 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 6 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 5 generations backK143717 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2015
- 4 generations backK153531 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2016
- 3 generations backK192504 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2019
- 2 generations backK200961 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2020
- 1 generation backK220136 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2022
- This deviceK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · 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 · 2 generations on1descendant
- K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −14 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −13 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −12 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −11 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −10 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −9 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −8 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −7 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −6 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −5 | K143717 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2015 | — |
| −4 | K153531 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2016 | — |
| −3 | 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 | — |
| 0 (this device) | 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 |
| +2 | K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +3 | K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +2 | K251135 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2025 | — |
| +1 | K233154 | SkyOPS™ Orthopedic Plate System | Sky Surgical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K220136 | Treace Medical Concepts (TMC) Plating SystemSummary page 4…40 (Smooth or threaded metallic bone fixation fastener) Panel: 87- Orthopedic Product Code(s): HRS, HWC Predicate Device(s): Primary Predicate: x K220136 Treace Medical Concepts (TMC) Plating System Additional Predicates: x K181872 CrossRoads Extremity Systems, LLC. MIS Bunion S… | 2022 |
| * | K181872 | MIS Bunion SystemSummary page 4…Orthopedic Product Code(s): HRS, HWC Predicate Device(s): Primary Predicate: x K220136 Treace Medical Concepts (TMC) Plating System Additional Predicates: x K181872 CrossRoads Extremity Systems, LLC. MIS Bunion System x K101962, OrthoHelix Surgical Designs Inc., Mini MaxLock Extreme Plating… | 2019 |
| * | K101962 | Mini Maxlock Extreme Plating SystemSummary page 4…imary Predicate: x K220136 Treace Medical Concepts (TMC) Plating System Additional Predicates: x K181872 CrossRoads Extremity Systems, LLC. MIS Bunion System x K101962, OrthoHelix Surgical Designs Inc., Mini MaxLock Extreme Plating System… | 2010 |
What descends from it? (7)
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 27 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 22 of the 98 ancestors have a recall of any class.
- Of its descendants, K240173 (Treace Medical Concepts, Inc., 2024) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 adult and pediatric patients aged >12 years. 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 -…
Read the full statement (172 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 adult and pediatric patients aged >12 years. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221181: Treace Medical Concepts (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/K221181
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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