510(k) · Cleared
Recalled · Class II · 2021WishBone Medical Plate and Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wishbone Medical, Inc. · HRS Plate, Fixation, Bone
Cleared on Oct 4, 2018 after a 196-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 4, 2018
- Review
- 196 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK180736 WishBone Medical Plate and Screw SystemWishbone Medical, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK213489 Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole…Wishbone Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK230527 WishBone Medical Plate and Screw SystemWishbone Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK203467 WishBone Medical Plate and Screw SystemWishbone Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK182704 WishBone Guided Growth SystemWishbone Medical · 2019 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K213489Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula PlateWishbone Medical, Inc. · 2022 · cites it directly1descendant
- K230527WishBone Medical Plate and Screw SystemWishbone Medical, Inc. · 2023 · cites it directly0descendants
- K203467WishBone Medical Plate and Screw SystemWishbone Medical, Inc. · 2020 · cites it directly0descendants
- K182704WishBone Guided Growth SystemWishbone Medical · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K180736 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | 2018 | — |
| +1 | K213489 | Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight… | Wishbone Medical, Inc. | 2022 | — |
| +1 | K230527 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | 2023 | — |
| +1 | K203467 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | 2020 | — |
| +1 | K182704 | WishBone Guided Growth System | Wishbone Medical | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
4 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 |
|---|---|---|---|---|
| Apr 30, 2021 | Class II | Z-1794-2021 | Process control | Nonconformities were discovered to the engineering specifications for implant plates and screws. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K213489 (Wishbone Medical, Inc., 2022) has gone furthest, with 1 descendant 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. 2018, 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 WishBone Medical Plate and Screw System is used for pediatric and adult 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 fractures of the clavicle, scapula, humerus, ulna, radius, middle hand, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, and treatment of the calcaneus.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K180736 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180736: WishBone Medical Plate and Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180736
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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