510(k) · Cleared
ClearedMaxlock Extreme 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 6, 2012 as substantially equivalent to K113048 (Orthohelix Surgical Designs, Inc., 2012) after a 59-day review. Its family tree reaches back 10 generations to 1996. 39 later devices descend from it.
- Decided
- Sep 6, 2012
- Review
- 59 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K954385 (1996). 37 ancestors in all, the oldest K920738 (1992). 39 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 2 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 1 generation backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- This deviceK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- Descendant · cites it directly · 38 of its ownK123203 Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012
- Descendant · 2 generations on · 32 of its ownK132591 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013
- Descendant · cites it directly · 25 of its ownK153379 AxSOS 3TiStryker GmbH · 2016
- Descendant · 2 generations on · 24 of its ownK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- Descendant · 2 generations on · 17 of its ownK172350 AxSOS 3 TiStryker GmbH · 2017
Show all 10 generations
- Root · 10 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 9 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 8 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 7 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 6 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 5 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 4 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 3 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 2 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 1 generation backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- This deviceK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc. · 2012 · cites it directly38descendants
- K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013 · 2 generations on32descendants
- K153379AxSOS 3TiStryker GmbH · 2016 · cites it directly25descendants
- K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017 · 2 generations on24descendants
- K172350AxSOS 3 TiStryker GmbH · 2017 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −9 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −8 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −7 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −6 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −5 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −4 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −3 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −2 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −1 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| 0 (this device) | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| +1 | K123203 | Maxlock Extreme System Model MXL | Orthohelix Surgical Designs, Inc. | 2012 | — |
| +2 | K132591 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2013 | — |
| +1 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| +2 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| +2 | K172350 | AxSOS 3 Ti | Stryker GmbH | 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 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 9 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (1)
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 |
|---|---|---|---|
| * | K113048 | Maxlock Extreme SystemSummary page 2…. Substantial Equivalence: The new Maxiock Extreme® System is substantially equivalent to the existing Orthol-elix MaxLock Extreme® System (K113048). Finite element analysis comparing the strength of the subject and predicate… | 2012 |
What descends from it? (39)
See all 392 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 16 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 37 ancestors have a recall of any class.
- Of its descendants, K123203 (Orthohelix Surgical Designs, Inc., 2012) has gone furthest, with 38 descendants of its own.
- 3 other devices also cite its predicate K113048.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 System is indicated for the following: *The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot…
Read the full statement (141 words)
The MaxLock Extreme System is indicated for the following:
*The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
*The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
*The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
*The MaxLock Extreme Distal Radius Module is 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/K122005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122005: Maxlock Extreme System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122005
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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