510(k) · Cleared
ClearedMaxlock Extreme Extremity Plating System with Variable Angle Technology
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 Apr 20, 2010 as substantially equivalent to K073624 (Orthohelix Surgical Designs, Inc., 2008) and 2 other predicates after a 47-day review. Its family tree reaches back 7 generations to 1996. 339 later devices descend from it.
- Decided
- Apr 20, 2010
- Review
- 47 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K954385 (1996). 25 ancestors in all, the oldest K920738 (1992). 339 later devices descend from it, 8 citing it directly.
- Root · 7 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 6 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 5 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 4 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 3 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 2 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 1 generation backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- This deviceK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- Descendant · cites it directly · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- Descendant · cites it directly · 119 of its ownK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- Descendant · cites it directly · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- Descendant · cites it directly · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
Showing 5 of 339 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 339 · See all- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · cites it directly228descendants
- K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc. · 2010 · cites it directly119descendants
- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 2 generations on118descendants
- K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · cites it directly97descendants
- K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · cites it directly95descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −6 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −5 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −4 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −3 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −2 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −1 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| 0 (this device) | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| +1 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +1 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| +2 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| +1 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| +1 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
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 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 14 | 0 |
| 2013 | 5 | 0 |
| 2014 | 13 | 0 |
| 2015 | 24 | 0 |
| 2016 | 13 | 0 |
| 2017 | 29 | 0 |
| 2018 | 15 | 0 |
| 2019 | 19 | 0 |
| 2020 | 27 | 0 |
| 2021 | 24 | 0 |
| 2022 | 24 | 0 |
| 2023 | 28 | 0 |
| 2024 | 39 | 0 |
| 2025 | 24 | 0 |
| 2026 | 37 | 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 |
|---|---|---|---|
| * | K073624 | Modular Foot SystemSummary page 2…MaxLock Extreme® Extremity Plating System with Variable Angle Technology is substantially equivalent to currently marketed devices, the Orthol-elix Modular Foot System (K073624) and Clavicle Plating System (K090289) and the Stryker VariAx System (K0606 13). The new technology is a modification to the Orth… | 2008 |
| * | K090289 | Clavicle Plating SystemSummary page 2…stem with Variable Angle Technology is substantially equivalent to currently marketed devices, the Orthol-elix Modular Foot System (K073624) and Clavicle Plating System (K090289) and the Stryker VariAx System (K0606 13). The new technology is a modification to the Ortho~lelix Modular Foot System, K073624 a… | 2009 |
| * | K060613 | Variax Locking Plate SystemSummary page 2…ubstantially equivalent to currently marketed devices, the Orthol-elix Modular Foot System (K073624) and Clavicle Plating System (K090289) and the Stryker VariAx System (K0606 13). The new technology is a modification to the Ortho~lelix Modular Foot System, K073624 and Clavicle Plating System, K090289. The… | 2006 |
What descends from it? (339)
See all 3398 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | 2010 | 228 |
| K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | 2010 | 119 |
| K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | 2012 | 97 |
| K121651 | Ortholoc 3DI Midfoot/Flatfoot System | 2012 | 95 |
| K111041 | Mini Variable System | 2011 | 77 |
| K113048 | Maxlock Extreme System | 2012 | 52 |
| K170401 | Piccolo Composite® Plate System | 2017 | 3 |
| K141004 | Intraosseous Fixation 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 4 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 25 ancestors have a recall of any class.
- Of its descendants, K100776 (Synthes (Usa), 2010) has gone furthest, with 228 descendants of its own.
- 4 other devices also cite its predicate K073624.
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?
Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomnies of the clavicle and small bones in the hand, wrist, foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100618
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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