510(k) · Cleared
ClearedAxsos 3 TI Locking Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Trauma AG · HRS Plate, Fixation, Bone
Cleared on Jun 20, 2014 as substantially equivalent to K013248 (Synthes (Usa), 2001) and 3 other predicates after a 51-day review. Its family tree reaches back 10 generations to 1996. 26 later devices descend from it.
- Decided
- Jun 20, 2014
- Review
- 51 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K962616 (1996). 45 ancestors in all, the oldest K890939 (1989). 26 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 2 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 1 generation backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- This deviceK141121 Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2014
- Descendant · cites it directly · 25 of its ownK153379 AxSOS 3TiStryker GmbH · 2016
- Descendant · 2 generations on · 24 of its ownK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- Descendant · 2 generations on · 17 of its ownK172350 AxSOS 3 TiStryker GmbH · 2017
- Descendant · 3 generations on · 11 of its ownK181091 AxSOS 3 TiStryker GmbH · 2018
- Descendant · 3 generations on · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 2 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 1 generation backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- This deviceK141121 Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2014
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K153379AxSOS 3TiStryker GmbH · 2016 · cites it directly25descendants
- K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017 · 2 generations on24descendants
- K172350AxSOS 3 TiStryker GmbH · 2017 · 2 generations on17descendants
- K181091AxSOS 3 TiStryker GmbH · 2018 · 3 generations on11descendants
- K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −2 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −1 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| 0 (this device) | K141121 | Axsos 3 TI Locking Plate System | Stryker Trauma AG | 2014 | — |
| +1 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| +2 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| +2 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | — |
| +3 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | — |
| +3 | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 8 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K013248 | Synthes LCP Distal Tibia PlatesSummary page 2…ice is substantially equivalent in intended use, design, materials and operational principles to the following predicate devices: * Synthes LCP Distal Tibia Plates (1(013248) * Synthes (USA) 3.5/4.5MM LCP Medial Proximal Tibia Plates (K050646) * Peri-Loc Bone Plating and Screw System (1(083032)… | 2001 |
| * | K050646 | Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSummary page 2…operational principles to the following predicate devices: * Synthes LCP Distal Tibia Plates (1(013248) * Synthes (USA) 3.5/4.5MM LCP Medial Proximal Tibia Plates (K050646) * Peri-Loc Bone Plating and Screw System (1(083032) * Synthes Peri-Prosthetic Screws (K(041533) The subject plates and scr… | 2005 |
| * | K083032 | Peri-Loc Bone Plating and Screw SystemSummary page 2…s: * Synthes LCP Distal Tibia Plates (1(013248) * Synthes (USA) 3.5/4.5MM LCP Medial Proximal Tibia Plates (K050646) * Peri-Loc Bone Plating and Screw System (1(083032) * Synthes Peri-Prosthetic Screws (K(041533) The subject plates and screws are substantially equivalent to the predicate devic… | 2009 |
| * | K041533 | Synthes (Usa) [Synthes} Peri-Prosthetic ScrewsSummary page 2…48) * Synthes (USA) 3.5/4.5MM LCP Medial Proximal Tibia Plates (K050646) * Peri-Loc Bone Plating and Screw System (1(083032) * Synthes Peri-Prosthetic Screws (K(041533) The subject plates and screws are substantially equivalent to the predicate devices in regards to intended use, design, material… | 2004 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153379 | AxSOS 3Ti | 2016 | 25 |
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 18 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 11 of the 45 ancestors have a recall of any class.
- Of its descendants, K153379 (Stryker GmbH, 2016) has gone furthest, with 25 descendants of its own.
- 19 other devices also cite its predicate K013248.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation.
Indications include:
Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
Non-unions and malunions
Normal and osteopenic bone
Osteotomies
Periprosthetic fractures of the femur and proximal tibia
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141121: Axsos 3 TI Locking Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141121
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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