510(k) · Cleared
ClearedMaxlock
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 May 27, 2005 as substantially equivalent to K920738 (Ace Orthopedic Manufacturing Co., 1992) and 1 other predicate after a 51-day review. Its family tree reaches back 5 generations to 1996. 343 later devices descend from it.
- Decided
- May 27, 2005
- Review
- 51 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954385 (1996). 19 ancestors in all, the oldest K920738 (1992). 343 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 4 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 3 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 2 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 1 generation backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- This deviceK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- Descendant · cites it directly · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- Descendant · 2 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- Descendant · 2 generations on · 119 of its ownK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
Showing 5 of 343 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 343 · See all- K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · cites it directly342descendants
- K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 2 generations on339descendants
- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 2 generations on228descendants
- K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc. · 2010 · 2 generations on119descendants
- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 3 generations on118descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −4 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −3 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −2 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −1 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| 0 (this device) | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| +1 | 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 | — |
| +2 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +2 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| +3 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 4 | 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 | 38 | 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? (2)
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 |
|---|---|---|---|
| * | K920738 | Ace 100 Degrees Tubular PlateSummary page 1…on Plates and Screws Classification Name Single/Multiple Component Metallic Fixation Appliances and Accessories Predicate Devices DePuy 100 Tubular Plate (K920738) KLS Martin Hand Plating System (K040598) Intended Use Repair of osteotoniies and fractures of small bones in the hand… | 1992 |
| * | K040598 | KLS Martin Hand Plating SystemSummary page 1…Single/Multiple Component Metallic Fixation Appliances and Accessories Predicate Devices DePuy 100 Tubular Plate (K920738) KLS Martin Hand Plating System (K040598) Intended Use Repair of osteotoniies and fractures of small bones in the hand and feet Device Description The MaxI… | 2004 |
What descends from it? (343)
See all 3431 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073624 | Modular Foot System | 2008 | 342 |
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 9 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K073624 (Orthohelix Surgical Designs, Inc., 2008) has gone furthest, with 342 descendants of its own.
- 2 other devices also cite its predicate K920738.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Small Bone System is indicated for the repair of osteotomies and fractures of:
* Phalanges of the hands and feet.
* Metacarpals and metatarsals.
* Carpals and tarsal bones.
* The wrist and ankle and,
* Arthrodesis of the hands, wrists, foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050868: Maxlock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050868
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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