510(k) · Cleared
ClearedVariax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick
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 Apr 25, 2012 as substantially equivalent to K112111 (Acumed, LLC, 2011) and 5 other predicates after a 126-day review. Its family tree reaches back 9 generations to 1979. 40 later devices descend from it.
- Decided
- Apr 25, 2012
- Review
- 126 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K792022 (1979). 79 ancestors in all. 40 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations between
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 1 generation backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- This deviceK113760 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 · cites it directly · 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
- Descendant · cites it directly · 13 of its ownK140259 Variax Clavicle Hook PlateStryker Trauma AG · 2014
Show all 9 generations
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 7 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 6 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 5 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 4 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 1 generation backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- This deviceK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- 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 · cites it directly16descendants
- K173135VariAx 2 SystemStryker GmbH · 2017 · 3 generations on13descendants
- K140259Variax Clavicle Hook PlateStryker Trauma AG · 2014 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −8 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −7 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −6 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −5 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −4 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −3 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −2 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −1 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| 0 (this device) | 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 | — |
| +1 | K130116 | Superior Lateral Variax Clavicle Plate | Stryker Trauma AG | 2013 | — |
| +3 | K173135 | VariAx 2 System | Stryker GmbH | 2017 | — |
| +1 | K140259 | Variax Clavicle Hook Plate | Stryker Trauma AG | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 8 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K112111 | Acu-Sinch Repair System and Acumed Suture AnchorSummary page 1…ct Codes: 87HRS, 87HWC Legally marketed device to which substantial equivalence isclaimed: Plate design and Intended Use: Acumed Clavicle Plating System: K 112 111, Synthes Clavicle Plating System: K 10 1536 and K000684 Materials & Screws: Variax Elbow: K 10 105… | 2011 |
| * | K101536 | 2.7/3.5MM VA-LCP Anteriro Clavicle Plate SystemSummary page 1…stantial equivalence isclaimed: Plate design and Intended Use: Acumed Clavicle Plating System: K 112 111, Synthes Clavicle Plating System: K 10 1536 and K000684 Materials & Screws: Variax Elbow: K 10 1056, K073527 Aiming Block: Variax Distal Radius Aiming Block cleared for use… | 2010 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…alence isclaimed: Plate design and Intended Use: Acumed Clavicle Plating System: K 112 111, Synthes Clavicle Plating System: K 10 1536 and K000684 Materials & Screws: Variax Elbow: K 10 1056, K073527 Aiming Block: Variax Distal Radius Aiming Block cleared for use via KI 11245… | 2000 |
| * | K101056 | Variax Elbow SystemSummary page 1…d Use: Acumed Clavicle Plating System: K 112 111, Synthes Clavicle Plating System: K 10 1536 and K000684 Materials & Screws: Variax Elbow: K 10 1056, K073527 Aiming Block: Variax Distal Radius Aiming Block cleared for use via KI 112455 Device Description: The Variax Clavicle S… | 2010 |
| * | K073527 | Variax Elbow SystemSummary page 1…ed Clavicle Plating System: K 112 111, Synthes Clavicle Plating System: K 10 1536 and K000684 Materials & Screws: Variax Elbow: K 10 1056, K073527 Aiming Block: Variax Distal Radius Aiming Block cleared for use via KI 112455 Device Description: The Variax Clavicle System con… | 2008 |
| * | K112455 | Aiming Blocks for Variax Distal Radius PlatesSummary page 1…lavicle Plating System: K 10 1536 and K000684 Materials & Screws: Variax Elbow: K 10 1056, K073527 Aiming Block: Variax Distal Radius Aiming Block cleared for use via KI 112455 Device Description: The Variax Clavicle System consists of anatomically contoured Anterior and Superior Lateral Plates as well a… | 2011 |
What descends from it? (40)
See all 404 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 33 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 13 of the 79 ancestors have a recall of any class.
- Of its descendants, K132502 (Stryker Trauma AG, 2013) has gone furthest, with 21 descendants of its own.
- 4 other devices also cite its predicate K112111.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Clavicle Anterior/Superior Lateral and Anterior/Superior Midshaft Plates are indicated for fixation of single, segmental and comminuted fractures, osteotomies, mal-unions, and non-unions of the clavicle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113760
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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