510(k) · Cleared
Recalled · 2011Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws
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 30, 2010 as substantially equivalent to K073624 (Orthohelix Surgical Designs, Inc., 2008) and 3 other predicates after a 62-day review. Its family tree reaches back 8 generations to 1996. 119 later devices descend from it. It has been recalled once.
- Decided
- Sep 30, 2010
- Review
- 62 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K954385 (1996). 28 ancestors in all, the oldest K920738 (1992). 119 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 7 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 6 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 5 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 4 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 3 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 2 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 1 generation backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- This deviceK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010
- Descendant · cites it directly · 77 of its ownK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- Descendant · 2 generations on · 64 of its ownK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- Descendant · cites it directly · 52 of its ownK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- Descendant · 2 generations on · 39 of its ownK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- Descendant · 3 generations on · 38 of its ownK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · See all- K111041Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011 · cites it directly77descendants
- K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012 · 2 generations on64descendants
- K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012 · cites it directly52descendants
- K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012 · 2 generations on39descendants
- K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012 · 3 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −7 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −6 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −5 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −4 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −3 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −2 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −1 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| 0 (this device) | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | — |
| +1 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| +2 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| +1 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| +2 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| +3 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 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 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 12 | 0 |
| 2018 | 7 | 0 |
| 2019 | 8 | 0 |
| 2020 | 12 | 0 |
| 2021 | 9 | 0 |
| 2022 | 5 | 0 |
| 2023 | 13 | 0 |
| 2024 | 9 | 0 |
| 2025 | 7 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K073624 | Modular Foot SystemSummary page 1…Substantial Equivalence: The MaxLock Extreme® System Distal Radius Plates and Screws are equivalent to the OrthoHelix Modular Foot System (1(073624) and its subsequent Special 510(k) submission (K(100618). In addition, the… | 2008 |
| * | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle TechnologySummary page 1…ews are equivalent to the OrthoHelix Modular Foot System (1(073624) and its subsequent Special 510(k) submission (K(100618). In addition, the plates are equivalent to the Hand Innovations Distal Volar Radius… | 2010 |
| * | K002775 | Distal Volar Radius Fracture Repair SystemSummary page 1…0618). In addition, the plates are equivalent to the Hand Innovations Distal Volar Radius Fracture Repair System (1(002775) and the screws are equivalent to the Synthes Modular Mini Fragment LCP System (K(063049). No new… | 2000 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 1…Fracture Repair System (1(002775) and the screws are equivalent to the Synthes Modular Mini Fragment LCP System (K(063049). No new issues of safety and effectiveness have been raised. Mechanical testing was c… | 2006 |
What descends from it? (119)
See all 1192 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 22, 2011 | Not classified | Z-0421-2012 | Nonconforming Material/Component | The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing. |
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.
- 5 of the 28 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.
- 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?
The MaxLock Extreme® Distal Radius Plates and Screws are indicated for fractures and osteotomies of the distal radius in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102156: Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102156
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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