510(k) · Cleared
Recalled · 2011Mini Maxlock Extreme Plating 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 Sep 27, 2010 as substantially equivalent to K063049 (Synthes (Usa), 2006) and 3 other predicates after a 76-day review. Its family tree reaches back 7 generations to 1996. 85 later devices descend from it. It has been recalled once.
- Decided
- Sep 27, 2010
- Review
- 76 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 7 generations to K954385 (1996). 27 ancestors in all, the oldest K920738 (1992). 85 later devices descend from it, 7 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 deviceK101962 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2010
- Descendant · cites it directly · 77 of its ownK111041 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 · cites it directly · 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
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- K111041Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011 · cites it directly77descendants
- 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 · cites it directly31descendants
- K172300CoLink View Plating SystemIn2bones USA, LLC · 2017 · 2 generations on16descendants
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) | K101962 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2010 | — |
| +1 | 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 | — |
| +1 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| +2 | K172300 | CoLink View Plating System | In2bones USA, LLC | 2017 | — |
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 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 | 5 | 0 |
| 2024 | 9 | 0 |
| 2025 | 4 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 1…ntial Equivalence: The Mini MlaxlLock Extreme® Plating System is substantially equivalent to the Synthes Modular Mini Fragment LCP System (1(063049), the Small Bone Innovations Hand Fracture System (K(050462), the DePuy Ort… | 2006 |
| * | K050462 | Sbi Hand Fixation System (TM)Summary page 1…lent to the Synthes Modular Mini Fragment LCP System (1(063049), the Small Bone Innovations Hand Fracture System (K(050462), the DePuy Orthopedic Small Bone Locking Plate System (K(083364), and the… | 2005 |
| * | K083364 | 2.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM Locking…Summary page 1…the Small Bone Innovations Hand Fracture System (K(050462), the DePuy Orthopedic Small Bone Locking Plate System (K(083364), and the OrthoHelix Modular Foot System (1(073624). Static mechanical testing… | 2008 |
| * | K073624 | Modular Foot SystemSummary page 1…050462), the DePuy Orthopedic Small Bone Locking Plate System (K(083364), and the OrthoHelix Modular Foot System (1(073624). Static mechanical testing and calculations comparing the bending and torsional strength of the… | 2008 |
What descends from it? (85)
See all 857 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111041 | Mini Variable System | 2011 | 77 |
| K120157 | Mini Maxlock Extreme Plating System | 2012 | 64 |
| K140397 | Paralock Plating System / Tuffnek Screw | 2014 | 31 |
| K221181 | Treace Medical Concepts (TMC) Plating System | 2023 | 7 |
| K240173 | Treace Medical Systems (TMC) Plating System | 2024 | 4 |
| K170401 | Piccolo Composite® Plate System | 2017 | 3 |
| K254053 | APS Spear Locking Plate | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2011 | Not classified | Z-3081-2011 | Nonconforming Material/Component | The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement. |
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.
- 6 of the 27 ancestors have a recall of any class.
- Of its descendants, K111041 (Orthohelix Surgical Designs, Inc., 2011) has gone furthest, with 77 descendants of its own.
- 39 other devices also cite its predicate K063049.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101962: Mini Maxlock Extreme Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101962
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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