510(k) · Cleared
ClearedVariAx 2 System, VariAx 2 Mini Fragment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · HRS Plate, Fixation, Bone
Cleared on Aug 23, 2019 as substantially equivalent to K132886 (Smith & Nephew, Inc., 2014) and 2 other predicates after an 87-day review. Its family tree reaches back 14 generations to 1979. 10 later devices descend from it.
- Decided
- Aug 23, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K792022 (1979). 137 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations between
- 3 generations backK140769 Variax 2 SystemStryker Trauma AG · 2014
- 2 generations backK173135 VariAx 2 SystemStryker GmbH · 2017
- 1 generation backK180500 VariAx 2 SystemStryker GmbH · 2018
- This deviceK191412 VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019
- Descendant · cites it directly · 4 of its ownK212581 VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH · 2022
- Descendant · 2 generations on · 2 of its ownK233919 VariAx 2 Distal Radius SystemStryker GmbH · 2024
- Descendant · cites it directly · 2 of its ownK220937 Arthrex Mini Fragment SystemArthrex, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK242554 Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK242343 BPS Wrist Fracture SystemOrthonovis, Inc. · 2024
Show all 14 generations
- Root · 14 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 13 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 12 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 11 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 10 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 9 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 8 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 7 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 6 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 5 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 4 generations backK132502 Variax 2 SystemStryker Trauma AG · 2013
- 3 generations backK140769 Variax 2 SystemStryker Trauma AG · 2014
- 2 generations backK173135 VariAx 2 SystemStryker GmbH · 2017
- 1 generation backK180500 VariAx 2 SystemStryker GmbH · 2018
- This deviceK191412 VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH · 2022 · cites it directly4descendants
- K233919VariAx 2 Distal Radius SystemStryker GmbH · 2024 · 2 generations on2descendants
- K220937Arthrex Mini Fragment SystemArthrex, Inc. · 2022 · cites it directly2descendants
- K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2024 · 2 generations on1descendant
- K242343BPS Wrist Fracture SystemOrthonovis, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −13 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −12 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −11 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −10 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −9 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −8 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −7 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −6 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −5 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| −4 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| −3 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| −2 | K173135 | VariAx 2 System | Stryker GmbH | 2017 | — |
| −1 | K180500 | VariAx 2 System | Stryker GmbH | 2018 | — |
| 0 (this device) | K191412 | VariAx 2 System, VariAx 2 Mini Fragment System | Stryker GmbH | 2019 | — |
| +1 | K212581 | VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System | Stryker GmbH | 2022 | — |
| +2 | K233919 | VariAx 2 Distal Radius System | Stryker GmbH | 2024 | — |
| +1 | K220937 | Arthrex Mini Fragment System | Arthrex, Inc. | 2022 | — |
| +2 | K242554 | Arthrex VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2024 | — |
| +3 | K242343 | BPS Wrist Fracture System | Orthonovis, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 12 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 12 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K132886 | Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSummary page 6…Primary Predicate: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (K132886) Reference Device: Synthes (USA) Modular Mini Fragment LCP… | 2014 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 6…stem (K132886) Reference Device: Synthes (USA) Modular Mini Fragment LCP System (K063049) VariAx 2 System Primary Predicate: Vari… | 2006 |
| * | K180500 | VariAx 2 SystemSummary page 7…usly cleared Synthes (USA) Modular Mini Fragment LCP System (K063049), Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (K132886), and VariAx 2 System (K180500) in regard to intended use, material, design, and operational principles. Non-Clinical Testing Comparative mechanical testing t… | 2018 |
What descends from it? (10)
3 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 40 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 26 of the 137 ancestors have a recall of any class.
- Of its descendants, K212581 (Stryker GmbH, 2022) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K132886.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 2 Mini Fragment System is indicated for fracture fixation, reconstruction, replantation, stabilization, reduction, fusions, osteotomies, mal-unions, and non-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 – 21 years) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. The VariAx 2 System is indicated for adult…
Read the full statement (126 words)
The VariAx 2 Mini Fragment System is indicated for fracture fixation, reconstruction, replantation, stabilization, reduction, fusions, osteotomies, mal-unions, and non-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 – 21 years) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures:
• Fracture fixation, including single, segmental, and comminuted fractures
• Revision, including nonunion and malunion
• Intra- and extra-articular fractures
• Compression fracture
• Displaced fracture
• Reconstruction
• Replantation
• Arthrodesis
• Osteotomy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191412: VariAx 2 System, VariAx 2 Mini Fragment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191412
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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