510(k) · Cleared
ClearedStryker VariAx 2 MIS Calcaneus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · HRS Plate, Fixation, Bone
Cleared on Jul 8, 2022 as substantially equivalent to K063875 (Howmedica Osteonics Corp., 2007) and 1 other predicate after a 60-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Jul 8, 2022
- Review
- 60 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K915818 (1992). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 4 generations backK981775 Depuy Ace Timax Calcaneal Peri-Articular PlateDepuy Ace Medical Co. · 1998
- 3 generations backK041786 Calcamea PlateNew Deal, S.A. · 2004
- 2 generations backK090582 Calcaneal Fracture Plate SystemTornier, Inc. · 2009
- 1 generation backK132898 A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp · 2013
- This deviceK221346 Stryker VariAx 2 MIS CalcaneusStryker GmbH · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −4 | K981775 | Depuy Ace Timax Calcaneal Peri-Articular Plate | Depuy Ace Medical Co. | 1998 | — |
| −3 | K041786 | Calcamea Plate | New Deal, S.A. | 2004 | — |
| −2 | K090582 | Calcaneal Fracture Plate System | Tornier, Inc. | 2009 | — |
| −1 | K132898 | A.L.P.S. Calcaneal Plating System | Biomet Manufacturing Corp | 2013 | — |
| 0 (this device) | K221346 | Stryker VariAx 2 MIS Calcaneus | Stryker GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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? (2)
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 |
|---|---|---|---|
| * | K063875 | Stryker Foot Plating SystemSummary page 4…Phone: 484-889-5804 Fax: 201-831-6500 Date Prepared: May 6, 2022 Predicate: K063875: Stryker Foot Plating System Additional Predicate: K132898: Zimmer Biomet A.L.P.S. Calcaneal Plating System Des… | 2007 |
| * | K132898 | A.L.P.S. Calcaneal Plating SystemSummary page 4…500 Date Prepared: May 6, 2022 Predicate: K063875: Stryker Foot Plating System Additional Predicate: K132898: Zimmer Biomet A.L.P.S. Calcaneal Plating System Description This Traditional 510(k) submission is submitted to the U.S. FDA to… | 2013 |
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?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 6.1 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 12 other devices also cite its predicate K063875.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Stryker VariAx 2 MIS Calcaneus is indicated for fractures of the calcaneus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221346: Stryker VariAx 2 MIS Calcaneus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221346
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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