510(k) · Cleared
ClearedMini Variable System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthohelix Surgical Designs, Inc. · HRS Plate, Fixation, Bone
Cleared on Jun 6, 2011 as substantially equivalent to K101962 (Orthohelix Surgical Designs, Inc., 2010) and 2 other predicates after a 53-day review. Its family tree reaches back 9 generations to 1996. 77 later devices descend from it.
- Decided
- Jun 6, 2011
- Review
- 53 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K954385 (1996). 33 ancestors in all, the oldest K920738 (1992). 77 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 2 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 1 generation backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- This deviceK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- Descendant · cites it directly · 64 of its ownK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- Descendant · 2 generations on · 38 of its ownK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- Descendant · 2 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- Descendant · 2 generations on · 16 of its ownK172300 CoLink View Plating SystemIn2bones USA, LLC · 2017
- Descendant · 3 generations on · 14 of its ownK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
Show all 9 generations
- Root · 9 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 8 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 7 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 6 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 5 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 4 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 3 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 2 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 1 generation backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- This deviceK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012 · cites it directly64descendants
- K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012 · 2 generations on38descendants
- K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 2 generations on31descendants
- K172300CoLink View Plating SystemIn2bones USA, LLC · 2017 · 2 generations on16descendants
- K181113CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −8 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −7 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −6 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −5 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −4 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −3 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −2 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −1 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| 0 (this device) | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| +1 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| +2 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| +2 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| +2 | K172300 | CoLink View Plating System | In2bones USA, LLC | 2017 | — |
| +3 | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 10 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 11 | 0 |
| 2021 | 8 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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? (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 |
|---|---|---|---|
| * | K101962 | Mini Maxlock Extreme Plating SystemSummary page 1…ubstantial Equivalence: The Mini Variable System is substantially equivalent to the OrthoHelix Mini MaxL-ock Extreme® Plating System Screws (K101962), the OrthoHelix MaxLock ExtremeO Distal Radius Screws (K102156), The Ortho… | 2010 |
| * | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsSummary page 1…Helix Mini MaxL-ock Extreme® Plating System Screws (K101962), the OrthoHelix MaxLock ExtremeO Distal Radius Screws (K102156), The OrthoHelix MaxL-ock ExtremeO System with Variable Angle Technology (K… | 2010 |
| * | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle TechnologySummary page 1…ck ExtremeO Distal Radius Screws (K102156), The OrthoHelix MaxL-ock ExtremeO System with Variable Angle Technology (K100618), and the Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System. Calculations and… | 2010 |
| * | — | Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System Named without a submission number |
What descends from it? (77)
See all 772 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 15 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- 8 of the 33 ancestors have a recall of any class.
- Of its descendants, K120157 (Orthohelix Surgical Designs, Inc., 2012) has gone furthest, with 64 descendants of its own.
- 6 other devices also cite its predicate K101962.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Mini Variable System, when used with the Mini MaxLock Extreme® Plating System, is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
The Mini Variable System, when used with the MaxLock Extreme® Distal Radius Plates and Screws, is intended for fractures and osteotomies of the distal radius in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111041: Mini Variable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111041
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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