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. · HRS Plate, Fixation, Bone
Cleared on May 13, 2010 as substantially equivalent to K073527 (Howmedica Osteonics Corp., 2008) after a 28-day review. Its family tree reaches back 7 generations to 1996. 58 later devices descend from it.
- Decided
- May 13, 2010
- Review
- 28 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). 58 later devices descend from it, 7 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 deviceK101056 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
- Descendant · 3 generations on · 13 of its ownK173135 VariAx 2 SystemStryker GmbH · 2017
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- 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
- K173135VariAx 2 SystemStryker GmbH · 2017 · 3 generations on13descendants
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) | 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 | — |
| +3 | K173135 | VariAx 2 System | Stryker GmbH | 2017 | — |
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 |
|---|---|---|
| 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 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…intended for fracture fixation of long bones. The indications for use provided below are have been modified compared to the predicate VariAx Elbow System's indications (K073527). Indications: Howmedica Osteonics is changing the indications for use of the VariAx Elbow System from "distal humerus and prox… | 2008 |
What descends from it? (58)
See all 587 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks… | 2012 | 40 |
| K132502 | Variax 2 System | 2013 | 21 |
| K112560 | Aptus (R) Distal Humerus System | 2011 | 8 |
| K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE… | 2023 | 7 |
| K250933 | LORRAINE 2.5/3.5mm Distal Humerus System | 2025 | 1 |
| K141677 | Variax Elbow Plating System | 2014 | 0 |
| 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 2.1 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K113760 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2012) has gone furthest, with 40 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?
Distal Humerus Plates are indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension. Olecranon Plates are indicated for intra-articular or extra-articular fractures of the proximal ulna, osteotomies, and nonunions. Longer plates may be used for proximal ulna fractures with diaphyseal extension.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101056: Variax Elbow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101056
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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