510(k) · Cleared
Recalled · Class II · 2021Charlotte (TM) MTP Bone Fusion Plate System Hex Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone
Cleared on Jul 9, 2014 as substantially equivalent to K042205 (Wrightmedicaltechnologyinc, 2004) after a 41-day review. Its family tree reaches back 1 generation to 2004. It has been recalled once.
- Decided
- Jul 9, 2014
- Review
- 41 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042205 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK042205 Bone Fusion Plate SystemWrightmedicaltechnologyinc · 2004
- This deviceK141417 Charlotte (TM) MTP Bone Fusion Plate System Hex ScrewWrightmedicaltechnologyinc · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042205 | Bone Fusion Plate System | Wrightmedicaltechnologyinc | 2004 | — |
| 0 (this device) | K141417 | Charlotte (TM) MTP Bone Fusion Plate System Hex Screw | Wrightmedicaltechnologyinc | 2014 | — |
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 |
|---|---|---|---|
| * | K042205 | Bone Fusion Plate SystemSummary page 1…ce: 21 CFR 888.3030- Class Il Device Product Code, Device Panel: HIRS - Orthopedic 3. Predicate Device: K042205 Bone Ftision Plate 4. Device Description The ClHARLOTTETN MTP Bone Fusion Plate System consists of plates… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2021 | Class II | Z-0401-2022 | Under Investigation by firm | Incorrect product is contained in the packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 CHARLOTTE MTP Bone Fusion Plate System is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces. Indications for Use: * Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint * Deformity due to hallux valgus * Deformity due to arthritis in the first metatarsal-phalangeal joint * Loss of motion-…
Read the full statement (109 words)
The CHARLOTTE MTP Bone Fusion Plate System is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces.
Indications for Use:
* Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
* Deformity due to hallux valgus
* Deformity due to arthritis in the first metatarsal-phalangeal joint
* Loss of motion- hallux rigidus
* Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsal-phalangeal joint
* Revision procedures where other treatments or devices have failed: and
* Chronic instability in the first metatarsal-phalangeal joint
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141417: Charlotte (TM) MTP Bone Fusion Plate System Hex Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141417
Report an extraction error
Are you the manufacturer?
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