510(k) · Cleared
ClearedCharlotte 7.0 Multi-Use Compression Screw and Washer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HWC Screw, Fixation, Bone
Cleared on Mar 29, 2007 after a 34-day review. The FDA summary names its predicate without a number. 60 later devices descend from it.
- Decided
- Mar 29, 2007
- Review
- 34 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
60 later devices descend from it, 3 citing it directly.
- This deviceK070525 Charlotte 7.0 Multi-Use Compression Screw and WasherWrightmedicaltechnologyinc · 2007
- Descendant · cites it directly · 34 of its ownK140741 Salvation Beams and Bolts SystemWrightmedicaltechnologyinc · 2014
- Descendant · 2 generations on · 24 of its ownK171018 Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017
- Descendant · 3 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- Descendant · cites it directly · 12 of its ownK110658 Aptus Cannulated Compression ScrewsMedartis AG · 2011
- Descendant · cites it directly · 11 of its ownK152062 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2016
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc · 2014 · cites it directly34descendants
- K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017 · 2 generations on24descendants
- K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 3 generations on21descendants
- K110658Aptus Cannulated Compression ScrewsMedartis AG · 2011 · cites it directly12descendants
- K152062BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2016 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070525 | Charlotte 7.0 Multi-Use Compression Screw and Washer | Wrightmedicaltechnologyinc | 2007 | — |
| +1 | K140741 | Salvation Beams and Bolts System | Wrightmedicaltechnologyinc | 2014 | — |
| +2 | K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System | Extremity Medical, LLC | 2017 | — |
| +3 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| +1 | K110658 | Aptus Cannulated Compression Screws | Medartis AG | 2011 | — |
| +1 | K152062 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 10 | 0 |
| 2023 | 9 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | — | CHARLOTTE High-Demand Compression Screw Named without a submission number | |
| * | — | Wright's Pre-amendment Tibia Bolt with Washers Named without a submission number |
What descends from it? (60)
See all 603 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?
- Of its descendants, K140741 (Wrightmedicaltechnologyinc, 2014) has gone furthest, with 34 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The CHARLOTTE TM 7.0 MUC Screw and Washer are indicated for fixation of bone fractures or for bone reconstruction. Examples include:
* Fixation of bone fragments, in long bones or small bones fractures
* Fracture management in the foot or hand
* Arthrodesis in hand, foot or ankle surgery
* Mono or Bi-cortical osteotomies in the foot or hand or in long bones
* Treatment of inferior tibio fibular diastasis
* Hindfoot arthrodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070525: Charlotte 7.0 Multi-Use Compression Screw and Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070525
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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