510(k) · Cleared
ClearedStryker 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 Apr 12, 2006 after a 19-day review. The FDA summary names its predicate without a number. 32 later devices descend from it.
- Decided
- Apr 12, 2006
- Review
- 19 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 5 citing it directly.
- This deviceK060798 Stryker Plating SystemHowmedica Osteonics Corp. · 2006
- Descendant · cites it directly · 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 · 2 generations on · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
- Descendant · 3 generations on · 9 of its ownK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017 · cites it directly24descendants
- K172350AxSOS 3 TiStryker GmbH · 2017 · 2 generations on17descendants
- K181091AxSOS 3 TiStryker GmbH · 2018 · 3 generations on11descendants
- K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · 2 generations on10descendants
- K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060798 | Stryker Plating System | Howmedica Osteonics Corp. | 2006 | — |
| +1 | 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 | — |
| +2 | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | — |
| +3 | K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 8 | 0 |
| 2024 | 4 | 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 |
|---|---|---|---|
| * | — | Stryker Plating System, Small Fragment Set Named without a submission number | |
| * | — | Stryker Plating System, Basic Fragment Set Named without a submission number | |
| * | — | Stryker Plating System, Pelvic Set Named without a submission number | |
| * | — | Stryker Locked Plating Set Named without a submission number |
What descends from it? (32)
See all 325 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162439 | AxSOS 3 Ti; Stryker Plating System | 2017 | 24 |
| K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System… | 2023 | 4 |
| K063095 | Humerus Locking Plating System | 2006 | 4 |
| 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, K162439 (Stryker GmbH, 2017) has gone furthest, with 24 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?
SPS Small Fragment Set The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following: One third tubular plate: fibula, metatarsals, metacarpals Fibular plate: fibula Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle Cloverleaf plate: proximal humerus, distal tibia Calcaneal…
Read the full statement (179 words)
SPS Small Fragment Set
The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following:
One third tubular plate: fibula, metatarsals, metacarpals
Fibular plate: fibula
Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle
Oblique T-plate: distal radius
T-plate: distal radius, calcaneus, lateral clavicle
Cloverleaf plate: proximal humerus, distal tibia
Calcaneal plate: calcaneus
Reconstructive plate: humerus, pelvis
Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.
SPS Basic Fragment Set
The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis.
T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060798 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060798: Stryker 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/K060798
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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