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 Mar 17, 2006 after an 18-day review. The FDA summary names its predicate without a number. 26 later devices descend from it.
- Decided
- Mar 17, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 8 citing it directly.
- This deviceK060514 Stryker Plating SystemHowmedica Osteonics Corp. · 2006
- Descendant · cites it directly · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- Descendant · 3 generations on · 7 of its ownK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly14descendants
- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 2 generations on10descendants
- K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 2 generations on8descendants
- K212433Anthem Fracture SystemGlobus Medical, Inc. · 2021 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060514 | Stryker Plating System | Howmedica Osteonics Corp. | 2006 | — |
| +1 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| +2 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| +3 | K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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? (26)
See all 268 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163361 | ANTHEM™ Fracture System | 2017 | 14 |
| K093761 | Optilock VL (Variable Angle Locking) Distal Radius Plating System | 2010 | 3 |
| K190391 | TDM Plate and Screw Systems | 2019 | 1 |
| K200062 | Foot and Ankle System | 2021 | 0 |
| K112926 | Axsos Locking Plate System | 2011 | 0 |
| K101930 | Memometal Navis Bone Plating System | 2011 | 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, K163361 (Globus Medical, Inc., 2017) has gone furthest, with 14 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 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…
Read the full statement (176 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
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/K060514 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060514: Stryker Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060514
Report an extraction error
Are you the manufacturer?
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