510(k) · Cleared
ClearedAxsos Locked Plating System Line Extension of 3MM Locking Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HRS Plate, Fixation, Bone
Cleared on Sep 1, 2009 as substantially equivalent to K050512 (Howmedica Osteonics Corp., 2005) and 3 other predicates after a 26-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Sep 1, 2009
- Review
- 26 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K050512 (2005). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK050512 Stryker Locked Plating SystemHowmedica Osteonics Corp. · 2005
- This deviceK092419 Axsos Locked Plating System Line Extension of 3MM Locking InsertsHowmedica Osteonics Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050512 | Stryker Locked Plating System | Howmedica Osteonics Corp. | 2005 | — |
| 0 (this device) | K092419 | Axsos Locked Plating System Line Extension of 3MM Locking Inserts | Howmedica Osteonics Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 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 |
|---|---|---|---|
| * | K050512 | Stryker Locked Plating SystemSummary page 2…m Stainless Steel. Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS ® System to the predicate device K050512, K060514, K060798, and K061012. DEPARTMENT OF HEALTH.& HUMAN SERVICES… | 2005 |
| * | K060514 | Stryker Plating SystemSummary page 2…ss Steel. Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS ® System to the predicate device K050512, K060514, K060798, and K061012. DEPARTMENT OF HEALTH.& HUMAN SERVICES… | 2006 |
| * | K060798 | Stryker Plating SystemSummary page 2…Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS ® System to the predicate device K050512, K060514, K060798, and K061012. DEPARTMENT OF HEALTH.& HUMAN SERVICES… | 2006 |
| * | K061012 | Axsos Plus Locking Plate SystemSummary page 2…nd mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS ® System to the predicate device K050512, K060514, K060798, and K061012. DEPARTMENT OF HEALTH.& HUMAN SERVICES… | 2006 |
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?
- 1 of the 4 ancestors has a recall of any class.
- 8 other devices also cite its predicate K050512.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092419 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092419: Axsos Locked Plating System Line Extension of 3MM Locking Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092419
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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