510(k) · Cleared
Recalled · Class II · 2024WishBone Guided Growth System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wishbone Medical · OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Cleared on Jun 25, 2019 as substantially equivalent to K090666 (OrthoPediatrics Corp., 2009) and 5 other predicates after a 271-day review. Its family tree reaches back 4 generations to 1999. It has been recalled once.
- Decided
- Jun 25, 2019
- Review
- 271 days
- Class
- Class II
- Product code
- OBT
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 4 generations to K993106 (1999). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK993106 Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and…Smith & Nephew, Inc. · 1999
- 3 generations backK073344 Orthopediatrics Plating SystemOrthopediatrics, LLC · 2008
- 2 generations backK081407 Orthopediatrics Pediplates SystemOrthoPediatrics Corp. · 2008
- 1 generation backK090666 PediplatesOrthoPediatrics Corp. · 2009
- This deviceK182704 WishBone Guided Growth SystemWishbone Medical · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) | Smith & Nephew, Inc. | 1999 | — |
| −3 | K073344 | Orthopediatrics Plating System | Orthopediatrics, LLC | 2008 | — |
| −2 | K081407 | Orthopediatrics Pediplates System | OrthoPediatrics Corp. | 2008 | — |
| −1 | K090666 | Pediplates | OrthoPediatrics Corp. | 2009 | — |
| 0 (this device) | K182704 | WishBone Guided Growth System | Wishbone Medical | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 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 OBT? 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 OBT device
- #1 K220190 The GIRO Growth Modulation Systemscore 5.1 · 4 generations · no Class I recall
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K090666 | PediplatesSummary page 4…mponent metallic bone fixation appliances and accessories. (CFR 888.3030) Primary Predicate Device: OrthoPediatrics Pedi-Plates (K090666, K171173) Additional Legally Marketed Orthofix Guided Growth System Eight-Plate, Quad-Plate (K110805) predicates:… | 2009 |
| * | K171173 | OrthoPediatrics Titanium PediPlates® SystemSummary page 4…etallic bone fixation appliances and accessories. (CFR 888.3030) Primary Predicate Device: OrthoPediatrics Pedi-Plates (K090666, K171173) Additional Legally Marketed Orthofix Guided Growth System Eight-Plate, Quad-Plate (K110805) predicates: W… | 2017 |
| * | K110805 | Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel)Summary page 4…30) Primary Predicate Device: OrthoPediatrics Pedi-Plates (K090666, K171173) Additional Legally Marketed Orthofix Guided Growth System Eight-Plate, Quad-Plate (K110805) predicates: WishBone Medical Plate And Screw System (K180736) BioPro Go-EZ Scr… | 2011 |
| * | K180736 | WishBone Medical Plate and Screw System Cleared while this submission was under review Summary page 4…) Additional Legally Marketed Orthofix Guided Growth System Eight-Plate, Quad-Plate (K110805) predicates: WishBone Medical Plate And Screw System (K180736) BioPro Go-EZ Screw (K081149) - for packaging and sterilization Bio… | 2018 |
| * | K081149 | Biopro GO-EZ ScrewSummary page 4…tem Eight-Plate, Quad-Plate (K110805) predicates: WishBone Medical Plate And Screw System (K180736) BioPro Go-EZ Screw (K081149) - for packaging and sterilization BioPro Toe MP Joint (K041595) – for packaging and sterilization… | 2008 |
| * | K041595 | Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870Summary page 4…Screw System (K180736) BioPro Go-EZ Screw (K081149) - for packaging and sterilization BioPro Toe MP Joint (K041595) – for packaging and sterilization Device Description: The WishBone Medical Guided Growth System is intended to be u… | 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 |
|---|---|---|---|---|
| Apr 5, 2024 | Class II | Z-1808-2024 | Nonconforming Material/Component | The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
- 4 of the 17 ancestors have a recall of any class.
- 1 other device also cites its predicate K090666.
How does its category compare?
All OBT devicesOBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OBT
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · OBT
Too few OBT 510(k)s in any year since 2007 to give a median.
Recalls per year · OBT
No recall names OBT since 2007.
Adverse event reports per year · OBT
2in 2025
MAUDE reports naming product code OBT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The WishBone Medical Guided Growth System is designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia), valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182704 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182704: WishBone Guided Growth System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182704
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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