510(k) · Cleared
ClearedVariax Elbow System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Feb 14, 2008 as substantially equivalent to K063875 (Howmedica Osteonics Corp., 2007) and 3 other predicates after a 59-day review. Its family tree reaches back 6 generations to 1996. 61 later devices descend from it.
- Decided
- Feb 14, 2008
- Review
- 59 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K962616 (1996). 19 ancestors in all, the oldest K885250 (1989). 61 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 4 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 3 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 1 generation backK062498 Profyle SystemHowmedica Osteonics Corp. · 2006 · Recalled
- This deviceK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008
- Descendant · cites it directly · 58 of its ownK101056 Variax Elbow SystemHowmedica Osteonics Corp. · 2010
- Descendant · cites it directly · 40 of its ownK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- Descendant · cites it directly · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013
- Descendant · 2 generations on · 19 of its ownK140769 Variax 2 SystemStryker Trauma AG · 2014
- Descendant · 2 generations on · 16 of its ownK130116 Superior Lateral Variax Clavicle PlateStryker Trauma AG · 2013
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K101056Variax Elbow SystemHowmedica Osteonics Corp. · 2010 · cites it directly58descendants
- K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · cites it directly40descendants
- K132502Variax 2 SystemStryker Trauma AG · 2013 · cites it directly21descendants
- K140769Variax 2 SystemStryker Trauma AG · 2014 · 2 generations on19descendants
- K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG · 2013 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −5 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −4 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −3 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −1 | K062498 | Profyle System | Howmedica Osteonics Corp. | 2006 | 1 |
| 0 (this device) | K073527 | Variax Elbow System | Howmedica Osteonics Corp. | 2008 | — |
| +1 | K101056 | Variax Elbow System | Howmedica Osteonics Corp. | 2010 | — |
| +1 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| +1 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| +2 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| +2 | K130116 | Superior Lateral Variax Clavicle Plate | Stryker Trauma AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 12 | 0 |
| 2025 | 6 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.4 · 14 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 |
|---|---|---|---|
| * | K063875 | Stryker Foot Plating SystemSummary page 2…igns of the Stryker Foot, Profyle®, Stryker : Locked Plating, and Universal Distal Radius Systems which were determined substantially equivalent in the following 510(k)s K063875, K062498, K050512, and K040022. Refer to Table 1 in Section I1 for a description of each predicate component, subject component,… | 2007 |
| * | K062498 | Profyle SystemSummary page 2…he Stryker Foot, Profyle®, Stryker : Locked Plating, and Universal Distal Radius Systems which were determined substantially equivalent in the following 510(k)s K063875, K062498, K050512, and K040022. Refer to Table 1 in Section I1 for a description of each predicate component, subject component, and modif… | 2006 |
| * | K050512 | Stryker Locked Plating SystemSummary page 2…r Foot, Profyle®, Stryker : Locked Plating, and Universal Distal Radius Systems which were determined substantially equivalent in the following 510(k)s K063875, K062498, K050512, and K040022. Refer to Table 1 in Section I1 for a description of each predicate component, subject component, and modifications.… | 2005 |
| * | K040022 | Stryker Leibinger Universal Distal Radius SystemSummary page 2…le®, Stryker : Locked Plating, and Universal Distal Radius Systems which were determined substantially equivalent in the following 510(k)s K063875, K062498, K050512, and K040022. Refer to Table 1 in Section I1 for a description of each predicate component, subject component, and modifications. Indications… | 2004 |
What descends from it? (61)
See all 616 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101056 | Variax Elbow System | 2010 | 58 |
| K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks… | 2012 | 40 |
| K132502 | Variax 2 System | 2013 | 21 |
| K093433 | Variax Elbow System Plate Line Extension | 2010 | 1 |
| K141301 | Maxlock Extreme Elbow Fracture System | 2014 | 0 |
| K092671 | Variax Elbow System Line Extension | 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?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K101056 (Howmedica Osteonics Corp., 2010) has gone furthest, with 58 descendants of its own.
- 12 other devices also cite its predicate K063875.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The VariAxTM Elbow System is intended for fracture fixation of long bones. Indications
include:
* Distal Humerus
* Proximal Ulna
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073527 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073527: Variax Elbow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073527
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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