510(k) · Cleared
ClearedVariax Elbow System Plate Line Extension
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 Jan 28, 2010 as substantially equivalent to K073527 (Howmedica Osteonics Corp., 2008) after an 85-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it.
- Decided
- Jan 28, 2010
- Review
- 85 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962616 (1996). 20 ancestors in all, the oldest K885250 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 2 generations backK062498 Profyle SystemHowmedica Osteonics Corp. · 2006 · Recalled
- 1 generation backK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008
- This deviceK093433 Variax Elbow System Plate Line ExtensionHowmedica Osteonics Corp. · 2010
- Descendant · cites it directly · 0 of its ownK141301 Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −6 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −5 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −4 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −2 | K062498 | Profyle System | Howmedica Osteonics Corp. | 2006 | 1 |
| −1 | K073527 | Variax Elbow System | Howmedica Osteonics Corp. | 2008 | — |
| 0 (this device) | K093433 | Variax Elbow System Plate Line Extension | Howmedica Osteonics Corp. | 2010 | — |
| +1 | K141301 | Maxlock Extreme Elbow Fracture System | Orthohelix Surgical Designs, Inc. | 2014 | — |
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 |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K073527 | Variax Elbow SystemSummary page 1…y Pure Titanium. The subject system was determined substantially equivalent in K073527. This Special 5 10(k) submission is intended to address the shortening… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141301 | Maxlock Extreme Elbow Fracture System | 2014 | 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 14 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K141301 (Orthohelix Surgical Designs, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K073527.
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 Elbow System Plate Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093433: Variax Elbow System Plate Line Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093433
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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