510(k) · Cleared
Recalled · Class II · 2014Charlotte Claw 3.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone
Cleared on Feb 27, 2008 after a 23-day review. The FDA summary names no predicate by number. 138 later devices descend from it. It has been recalled 10 times.
- Decided
- Feb 27, 2008
- Review
- 23 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 10
- Predicates
- 0
138 later devices descend from it, 2 citing it directly.
- This deviceK080295 Charlotte Claw 3.5Wrightmedicaltechnologyinc · 2008
- Descendant · cites it directly · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- Descendant · 2 generations on · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- Descendant · cites it directly · 53 of its ownK092528 Biomet Forerunner Locking Plate SystemBiomet Trauma (Aka Ebi, Lp) · 2010
- Descendant · 2 generations on · 52 of its ownK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- Descendant · 3 generations on · 39 of its ownK122005 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
Showing 5 of 138 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 138 · See all- K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · cites it directly97descendants
- K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · 2 generations on95descendants
- K092528Biomet Forerunner Locking Plate SystemBiomet Trauma (Aka Ebi, Lp) · 2010 · cites it directly53descendants
- K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012 · 2 generations on52descendants
- K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012 · 3 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080295 | Charlotte Claw 3.5 | Wrightmedicaltechnologyinc | 2008 | — |
| +1 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| +2 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| +1 | K092528 | Biomet Forerunner Locking Plate System | Biomet Trauma (Aka Ebi, Lp) | 2010 | — |
| +2 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| +3 | K122005 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 7 | 0 |
| 2015 | 9 | 0 |
| 2016 | 7 | 0 |
| 2017 | 11 | 0 |
| 2018 | 7 | 0 |
| 2019 | 7 | 0 |
| 2020 | 15 | 0 |
| 2021 | 9 | 0 |
| 2022 | 9 | 0 |
| 2023 | 15 | 0 |
| 2024 | 15 | 0 |
| 2025 | 10 | 0 |
| 2026 | 10 | 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?
The FDA summary names no predicate by number.
What descends from it? (138)
See all 1382 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 |
|---|---|---|---|---|
| Jul 30, 2014 | Class II | Z-2608-2014 | Device Design | Plates manufactured from an incorrect raw material. |
| Jul 30, 2014 | Class II | Z-2601-2014 | Device Design | Plates manufactured from an incorrect raw material. |
| Jul 30, 2014 | Class II | Z-2604-2014 | Device Design | Plates manufactured from an incorrect raw material. |
| Jul 30, 2014 | Class II | Z-2603-2014 | Device Design | Plates manufactured from an incorrect raw material. |
| Jul 30, 2014 | Class II | Z-2600-2014 | Device Design | Plates manufactured from an incorrect raw material. |
| Jul 30, 2014 | Class II | Z-2599-2014 | Device Design | Plates manufactured from an incorrect raw material. |
| Jul 30, 2014 | Class II | Z-2602-2014 | Device Design | Plates manufactured from an incorrect raw material. |
| Jul 30, 2014 | Class II | Z-2607-2014 | Device Design | Plates manufactured from an incorrect raw material. |
| Jul 30, 2014 | Class II | Z-2605-2014 | Device Design | Plates manufactured from an incorrect raw material. |
| Jun 7, 2010 | Not classified | Z-2188-2010 | Packaging process control | One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113014 (Wrightmedicaltechnologyinc, 2012) has gone furthest, with 97 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 CHARLOTTETM CLAW® 3.5 is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080295: Charlotte Claw 3.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080295
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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