(271 days)
Not Found
No
The summary describes a mechanical implant system for correcting bone deformities and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is designed to correct angular deformities in growing children, which directly addresses a health condition.
No
Explanation: The device is designed to correct angular deformities in growing children by redirecting the angle of growth of long bones, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the system includes implants made of 316-stainless steel and Ti-6Al-4V Titanium alloy, which are hardware components.
Based on the provided information, the WishBone Medical Guided Growth System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The provided description clearly states the device is an implantable system designed to be surgically placed in long bones to correct angular deformities. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use is for surgical intervention and mechanical correction. The purpose is to physically redirect bone growth, not to diagnose a condition or provide information about a patient's health status through laboratory testing.
The device is a surgical implant used for orthopedic correction in growing children.
N/A
Intended Use / Indications for Use
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 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).
Product codes
OBT
Device Description
The WishBone Medical Guided Growth System is intended to be used 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. The WishBone Medical Guided Growth System implants are made of a 316-stainless steel material in compliance of ASTM F138, and Ti-6Al-4V Titanium alloy compliant to ASTM F136. 316 stainless steel and Ti-Al-4V are biocompatible materials that are readily available and commonly used in implanted medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone(s), knee (femur and/or tibia), ankle, elbow (humerus), wrist (radius)
Indicated Patient Age Range
growing children
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical: Engineering analysis was conducted to demonstrate substantial equivalence to the OrthoPediatrics Pedi-Plates predicate components. Cleaning testing, including endotoxin testing, was performed.
Clinical Tests: None required as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K090666, K171173, K110805, K180736, K081149, K041595
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 25, 2019
WishBone Medical Mary Wetzel Chief Operating Officer 1250 North Pointe Drive Warsaw, Indiana 46992
Re: K182704
Trade/Device Name: WishBone Guided Growth System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: OBT Dated: May 22, 2019 Received: May 23, 2019
Dear Mary Wetzel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For- Shumaya Ali, MPH Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182704
Device Name
WishBone Medical Guided Growth System
Indications for Use (Describe)
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: valus 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).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒Prescription Use (Part 21 CFR 801 Subpart D) | ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image is a logo for WishBone Medical. The logo features a blue circle with a white wishbone inside. Below the circle, the word "WishBone" is written in a stylized font, with the word "MEDICAL" written in smaller letters below it. The logo is clean and modern, and the use of blue and white gives it a professional look.
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the WishBone Medical Guided Growth System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, "Format for Traditional and Abbreviated 410(k)s", issued on August 12, 2005.
| Sponsor: | WishBone Medical, Inc.
2150 North Pointe Dr.
Warsaw, IN, 46582
Phone: +1 (574) 306-4006
Fax: (574) 376-4746
Establishment Registration Number: 3013680140 |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mary Wetzel
Chief Operating Officer
MaryWetzel@wishbonemedical.com |
| Date: | February 13, 2018 |
| Subject Device: | Trade Name: WishBone Medical Guided Growth System
Common name(s): bone plate, bone screw
Classification Name:
OBT Single/multiple component metallic bone fixation appliances
and accessories. (CFR 888.3030) |
| Primary Predicate Device: | OrthoPediatrics Pedi-Plates (K090666, K171173) |
| Additional Legally Marketed
predicates: | Orthofix Guided Growth System Eight-Plate, Quad-Plate (K110805)
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 |
| Device Description: | The WishBone Medical Guided Growth System is intended to be used
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. The WishBone Medical Guided Growth System
implants are made of a 316-stainless steel material in compliance of
ASTM F138, and Ti-6Al-4V Titanium alloy compliant to ASTM F136. 316
stainless steel and Ti-Al-4V are biocompatible materials that are readily
available and commonly used in implanted medical devices. |
| Indications for Use: | 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). |
| Summary of Technical
Characteristics: | The rationale for substantial equivalence is based on consideration of the following characteristics:
Intended Use: same as the predicates Indications for Use: all the WishBone Medical Guided Growth System indications are the same as predicate indications. Materials: same as the predicates. Design Features: similar to predicates. Sterilization: same as BioPro predicate (K061798 and K041595) |
| Summary of Performance
Data (Clinical & Non-clinical): | Non-Clinical: Engineering analysis was conducted to demonstrate substantial equivalence to the OrthoPediatrics Pedi-Plates predicate components. Cleaning testing, including endotoxin testing, was performed.
Clinical Tests: None required as a basis for substantial equivalence. |
| Substantial Equivalence
Conclusion: | The subject device has the same intended use and indications for use as the predicate guided growth/plating systems. The subject device has similar technical characteristics to the predicate, and the engineering analyses demonstrate that:
Any differences do not raise new questions of safety and effectiveness, and The proposed device is expected to perform substantially equivalent to the legally marketed predicate devices |
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Image /page/4/Picture/1 description: The image shows the logo for WishBone Medical. The logo features a blue circle with a white wishbone inside. Below the circle, the word "WishBone" is written in a modern, sans-serif font, with the "W" and "B" capitalized. Underneath "WishBone", the word "MEDICAL" is written in smaller, all-caps letters.