510(k) · Cleared
ClearedThe Varia Fibula Locked Plating System Line Extension Addition of Straight Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp., Dba Stryker Orthopaedics · HRS Plate, Fixation, Bone
Cleared on Dec 7, 2010 as substantially equivalent to K081284 (Howmedica Osteonics Corp., 2008) and 2 other predicates after a 117-day review. Its family tree reaches back 2 generations to 2000. 77 later devices descend from it.
- Decided
- Dec 7, 2010
- Review
- 117 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K000684 (2000). 4 ancestors in all. 77 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 1 generation backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- This deviceK102282 The Varia Fibula Locked Plating System Line Extension Addition of…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010
- Descendant · cites it directly · 54 of its ownK123000 Integra Total Foot SystemsIntegra LifeSciences Corporation · 2012
- Descendant · 2 generations on · 23 of its ownK132594 Crosscheck Plating SystemSolana Surgical, LLC · 2013 · Recalled
- Descendant · 3 generations on · 22 of its ownK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- Descendant · 2 generations on · 21 of its ownK163293 Colink™ Plating SystemIn2bones USA, LLC · 2017 · Recalled
- Descendant · cites it directly · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K123000Integra Total Foot SystemsIntegra LifeSciences Corporation · 2012 · cites it directly54descendants
- K132594Crosscheck Plating SystemSolana Surgical, LLC · 2013 · 2 generations on23descendants
- K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015 · 3 generations on22descendants
- K163293Colink™ Plating SystemIn2bones USA, LLC · 2017 · 2 generations on21descendants
- K132502Variax 2 SystemStryker Trauma AG · 2013 · cites it directly21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −1 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| 0 (this device) | K102282 | The Varia Fibula Locked Plating System Line Extension Addition of Straight… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010 | — |
| +1 | K123000 | Integra Total Foot Systems | Integra LifeSciences Corporation | 2012 | — |
| +2 | K132594 | Crosscheck Plating System | Solana Surgical, LLC | 2013 | 21 |
| +3 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Wrightmedicaltechnologyinc | 2015 | — |
| +2 | K163293 | Colink™ Plating System | In2bones USA, LLC | 2017 | 2 |
| +1 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 6 | 0 |
| 2023 | 8 | 0 |
| 2024 | 11 | 0 |
| 2025 | 6 | 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? (3)
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 |
|---|---|---|---|
| * | K081284 | Variax Distal Fibula PlateSummary page 1…late, Fixation, Bone Description: This 510(k) submission is intended to add bone plates with a different geometry to the VariAx M fibular plate line which was cleared in K081284. The new plates are termed "Fibula Straight Plates" and consist of the shaft portion of the cleared plate plus an oblong screw ho… | 2008 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 1…her fixation plates (predicates) have been cleared with the approximate plate length of the subject device, including the Synthes 3.5 mm LCP® Medial Distal Tibia Plates (K001945) and Synthes One-Third Tubular Dynamic Compression Locking (DCL) (KOl 1335). Intended Use: The VariAxT'rFibula Locked Plating Sy… | 2000 |
| * | K011335 | Synths One-Third Tubular DCL Plate | 2001 |
What descends from it? (77)
See all 772 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K123000 (Integra LifeSciences Corporation, 2012) has gone furthest, with 54 descendants of its own.
- 7 other devices also cite its predicate K081284.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 VariAx Fibula Straight Plates are intended for use in internal fixation of the distal fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102282: The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102282
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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