510(k) · Cleared
ClearedTM Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyber Medical, LLC · HRS Plate, Fixation, Bone
Cleared on Dec 20, 2023 as substantially equivalent to K222381 (Stryker GmbH, 2023) and 2 other predicates after an 89-day review. Its family tree reaches back 19 generations to 1996. 1 later device descends from it.
- Decided
- Dec 20, 2023
- Review
- 89 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K954385 (1996). 419 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 15 generations between
- 3 generations backK181091 AxSOS 3 TiStryker GmbH · 2018
- 2 generations backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- 1 generation backK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- This deviceK233017 TM Plating SystemTyber Medical, LLC · 2023
- Descendant · cites it directly · 0 of its ownK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
Show all 19 generations
- Root · 19 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 18 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 17 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 16 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 15 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 14 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 13 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 12 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 11 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 10 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 9 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 8 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 7 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 6 generations backK153379 AxSOS 3TiStryker GmbH · 2016
- 5 generations backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- 4 generations backK172350 AxSOS 3 TiStryker GmbH · 2017
- 3 generations backK181091 AxSOS 3 TiStryker GmbH · 2018
- 2 generations backK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- 1 generation backK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- This deviceK233017 TM Plating SystemTyber Medical, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −18 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −17 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −16 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −15 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −14 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −13 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −12 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −11 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −10 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −9 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −8 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −7 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −6 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| −5 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| −4 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | — |
| −3 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | — |
| −2 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| −1 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker… | Stryker GmbH | 2023 | — |
| 0 (this device) | K233017 | TM Plating System | Tyber Medical, LLC | 2023 | — |
| +1 | K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 6 | 0 |
| 1993 | 3 | 0 |
| 1994 | 9 | 0 |
| 1995 | 16 | 0 |
| 1996 | 22 | 0 |
| 1997 | 8 | 0 |
| 1998 | 14 | 0 |
| 1999 | 15 | 0 |
| 2000 | 19 | 0 |
| 2001 | 24 | 0 |
| 2002 | 24 | 0 |
| 2003 | 11 | 0 |
| 2004 | 15 | 0 |
| 2005 | 24 | 0 |
| 2006 | 29 | 0 |
| 2007 | 17 | 0 |
| 2008 | 20 | 0 |
| 2009 | 20 | 0 |
| 2010 | 20 | 0 |
| 2011 | 9 | 0 |
| 2012 | 8 | 0 |
| 2013 | 4 | 0 |
| 2014 | 14 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 9 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemSummary page 4…condary) Product Code HRS/HWC I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K222381 Stryker Ax SOS 3 Ti HRS K210837 Smith & Nephew Plates and Screws HRS K222465 Tyber Medical Anatomical Plating System HRS Device D… | 2023 |
| * | K210837 | Smith & Nephew Plates and ScrewsSummary page 4…Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K222381 Stryker Ax SOS 3 Ti HRS K210837 Smith & Nephew Plates and Screws HRS K222465 Tyber Medical Anatomical Plating System HRS Device Description Summary 21 CFR 807.92… | 2021 |
| * | K222465 | Tyber Medical Anatomical Plating SystemSummary page 4…7.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K222381 Stryker Ax SOS 3 Ti HRS K210837 Smith & Nephew Plates and Screws HRS K222465 Tyber Medical Anatomical Plating System HRS Device Description Summary 21 CFR 807.92(a)(4) The system presented in this 510(k) s… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261207 | Exalta Proximal Tibia Plating System | 2026 | 0 |
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 10 months on median.
- 81 of the 419 ancestors have a recall of any class.
- Of its descendants, K261207 (Tyber Medical, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K222381.
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 TM Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the following indication categories: I. TM Plating System – Complete Articular The TM Plating system is indicated for the treatment of nonunions, malunions, osteotomies, and fractures of the femur and tibia. This includes simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and…
Read the full statement (161 words)
The TM Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of
the following indication categories:
I. TM Plating System – Complete Articular
The TM Plating system is indicated for the treatment of nonunions, malunions, osteotomies, and fractures of the femur
and tibia. This includes simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral
wedge and depression, diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures, periprosthetic, and
fractures with associated shaft fractures.
II. TM Plating System – Partial Articular
The partial articular (also called buttress or anti-glide) proximal tibia plates are indicated for stabilization and reduction of
proximal tibia fragments and treatment of partial articular fractures of the proximal tibia (AO/OTA Fracture
Classifications Type B). The partial articular straight plates are indicated for stabilization and reduction of long bone
fragments and partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and
for fracture fixation of the fibula.
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/K233017 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233017: TM 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/K233017
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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