510(k) · Cleared
ClearedStryker Foot 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 15, 2007 after a 76-day review. The FDA summary names its predicate without a number. 167 later devices descend from it.
- Decided
- Mar 15, 2007
- Review
- 76 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
167 later devices descend from it, 13 citing it directly.
- This deviceK063875 Stryker Foot Plating SystemHowmedica Osteonics Corp. · 2007
- 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 · cites it directly · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- Descendant · cites it directly · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
Showing 5 of 167 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 167 · 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
- K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · cites it directly31descendants
- K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · cites it directly24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063875 | Stryker Foot Plating System | Howmedica Osteonics Corp. | 2007 | — |
| +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 | — |
| +1 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| +1 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 6 | 0 |
| 2016 | 1 | 0 |
| 2017 | 17 | 0 |
| 2018 | 7 | 0 |
| 2019 | 13 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 10 | 0 |
| 2023 | 18 | 0 |
| 2024 | 21 | 0 |
| 2025 | 13 | 0 |
| 2026 | 18 | 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 |
|---|---|---|---|
| * | — | Profyle® System Named without a submission number | |
| * | — | Stryker® Plating System Named without a submission number | |
| * | — | DARCO Locking Bone Plate System Named without a submission number | |
| * | — | Synthes LCP Locking Calcaneal Plates and Modular Foot System Named without a submission number |
What descends from it? (167)
See all 16713 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 |
| K140397 | Paralock Plating System / Tuffnek Screw | 2014 | 31 |
| K131722 | I.T.S. Extremity Fixation Systems | 2013 | 24 |
| K140376 | Variax 2 System | 2014 | 23 |
| K132502 | Variax 2 System | 2013 | 21 |
| K151886 | Acumed Ankle and Small Fragment Base Set Update | 2015 | 15 |
| K131311 | Arix Foot System | 2013 | 9 |
| K131186 | Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System | 2013 | 8 |
| K141204 | Variax 2 One Third Tubular Plating System | 2014 | 7 |
| K161864 | ARIX Foot System | 2016 | 5 |
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. 2007, 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 Stryker® Foot Plating System is intended for use in internal fixation, reconstruction
or arthrodeses of small bones including the fore, mid- and hind foot and ankle.
Examples of these procedures may include but are not limited to replantation, lag screw
techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063875 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063875: Stryker Foot 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/K063875
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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