510(k) · Cleared
ClearedTyber Medical Distal Radius 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 Jul 30, 2025 as substantially equivalent to K232693 (Tyber Medical, LLC, 2023) and 3 other predicates after a 90-day review. Its family tree reaches back 18 generations to 1996.
- Decided
- Jul 30, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K954385 (1996). 264 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 18 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 14 generations between
- 3 generations backK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
- 2 generations backK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
- 1 generation backK232693 Tyber Medical Distal Radius Plating SystemTyber Medical, LLC · 2023
- This deviceK251361 Tyber Medical Distal Radius Plating SystemTyber Medical, LLC · 2025
Show all 18 generations
- Root · 18 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 17 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 16 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 15 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 14 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 13 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 12 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 11 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 10 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 9 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 8 generations backK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 7 generations backK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- 6 generations backK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- 5 generations backK153379 AxSOS 3TiStryker GmbH · 2016
- 4 generations backK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- 3 generations backK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
- 2 generations backK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
- 1 generation backK232693 Tyber Medical Distal Radius Plating SystemTyber Medical, LLC · 2023
- This deviceK251361 Tyber Medical Distal Radius Plating SystemTyber Medical, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −17 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −16 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −15 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −14 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −13 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −12 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −11 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −10 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −9 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −8 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −7 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −6 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| −5 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| −4 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| −3 | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | — |
| −2 | K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2023 | — |
| −1 | K232693 | Tyber Medical Distal Radius Plating System | Tyber Medical, LLC | 2023 | — |
| 0 (this device) | K251361 | Tyber Medical Distal Radius Plating System | Tyber Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 14 | 0 |
| 1997 | 2 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 13 | 0 |
| 2001 | 15 | 0 |
| 2002 | 14 | 0 |
| 2003 | 9 | 0 |
| 2004 | 11 | 0 |
| 2005 | 16 | 0 |
| 2006 | 16 | 0 |
| 2007 | 12 | 0 |
| 2008 | 13 | 0 |
| 2009 | 15 | 0 |
| 2010 | 13 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K232693 | Tyber Medical Distal Radius Plating SystemSummary page 5…3030 Product Code(s) HRS, HWC I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K232693 Tyber Medical Distal Radius Plating System HRS K233665 DePuy Synthes VOLT Mini Fragment Plating System, DePuy HRS Synthes VOLT S… | 2023 |
| * | K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…Summary page 5…cate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K232693 Tyber Medical Distal Radius Plating System HRS K233665 DePuy Synthes VOLT Mini Fragment Plating System, DePuy HRS Synthes VOLT Small Fragment Plating System K193554 APTUS® Forearm Sh… | 2024 |
| * | K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemSummary page 5…de K232693 Tyber Medical Distal Radius Plating System HRS K233665 DePuy Synthes VOLT Mini Fragment Plating System, DePuy HRS Synthes VOLT Small Fragment Plating System K193554 APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System HRS K182492 GEMINUS Distal Radius System HRS Device Description Summary 2… | 2020 |
| * | K182492 | Geminus Volar Distal Radius Plate SystemSummary page 5…Puy Synthes VOLT Mini Fragment Plating System, DePuy HRS Synthes VOLT Small Fragment Plating System K193554 APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System HRS K182492 GEMINUS Distal Radius System HRS Device Description Summary 21 CFR 807.92(a)(4) This traditional 510K is a line extension to the… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 50 of the 264 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Tyber Medical Distal Radius Plating System includes Distal Radius, Forearm, and Fragment-Specific Plates, which are indicated for fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.
The Tyber Medical Distal Radius Plating System is not for spinal use.
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/K251361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251361: Tyber Medical Distal Radius 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/K251361
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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