510(k) · Cleared
ClearedStryker Locked Plating System
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 Mar 21, 2005 after a 20-day review. The FDA summary names its predicate without a number. 79 later devices descend from it.
- Decided
- Mar 21, 2005
- Review
- 20 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
79 later devices descend from it, 9 citing it directly.
- This deviceK050512 Stryker Locked Plating SystemHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 61 of its ownK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008
- Descendant · 2 generations on · 58 of its ownK101056 Variax Elbow SystemHowmedica Osteonics Corp. · 2010
- Descendant · 2 generations on · 40 of its ownK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- Descendant · 2 generations on · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013
- Descendant · 3 generations on · 19 of its ownK140769 Variax 2 SystemStryker Trauma AG · 2014
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K073527Variax Elbow SystemHowmedica Osteonics Corp. · 2008 · cites it directly61descendants
- K101056Variax Elbow SystemHowmedica Osteonics Corp. · 2010 · 2 generations on58descendants
- K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · 2 generations on40descendants
- K132502Variax 2 SystemStryker Trauma AG · 2013 · 2 generations on21descendants
- K140769Variax 2 SystemStryker Trauma AG · 2014 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050512 | Stryker Locked Plating System | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K073527 | Variax Elbow System | Howmedica Osteonics Corp. | 2008 | — |
| +2 | K101056 | Variax Elbow System | Howmedica Osteonics Corp. | 2010 | — |
| +2 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| +2 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| +3 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 12 | 0 |
| 2025 | 7 | 0 |
| 2026 | 6 | 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? (1)
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 |
|---|---|---|---|
| * | — | Stryker Plating System Named without a submission number |
What descends from it? (79)
See all 799 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073527 | Variax Elbow System | 2008 | 61 |
| K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | 2020 | 9 |
| K093761 | Optilock VL (Variable Angle Locking) Distal Radius Plating System | 2010 | 3 |
| K123403 | Axsos Proximal Lateral Tibia Long Plates | 2013 | 0 |
| K101930 | Memometal Navis Bone Plating System | 2011 | 0 |
| K110176 | Axsos Locked Plating 4.0MM Locking Inserts | 2011 | 0 |
| K100475 | Axsos Locked Plating System Line Extension of 5MM Locking Inserts | 2010 | 0 |
| K092178 | Axsos Stryker Locked Plating System Line Extension of Cable Plugs | 2009 | 0 |
| K092419 | Axsos Locked Plating System Line Extension of 3MM Locking Inserts | 2009 | 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?
- Of its descendants, K073527 (Howmedica Osteonics Corp., 2008) has gone furthest, with 61 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.
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 but not limited to 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/K050512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050512: Stryker Locked 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/K050512
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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