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).

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.

AI/ML Overview

Here's an analysis of the provided text regarding the WishBone Medical Guided Growth System, focusing on acceptance criteria and study details.

Important Note: The provided text is a 510(k) Premarket Notification summary. For Class II medical devices like this, the goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to "prove" efficacy or meet specific performance acceptance criteria in the same way a PMA device or a de novo device might. The "acceptance criteria" here are therefore inferred from the demonstration of substantial equivalence, primarily through engineering analysis and comparison to predicate devices, rather than explicit numerical thresholds for clinical performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (as per 510(k) for substantial equivalence)
Intended Use: Same as predicates.	Same Intended Use: "The subject device has the same intended use... as the predicate guided growth/plating systems."
Indications for Use: Same as predicates.	Same Indications for Use: "all the WishBone Medical Guided Growth System indications are the same as predicate indications."
Materials: Same as predicates (biocompatible and commonly used).	Same Materials: "Implants are made of a 316-stainless steel material in compliance of ASTM F138, and Ti-6Al-4V Titanium alloy compliant to ASTM F136." These are "biocompatible materials that are readily available and commonly used in implanted medical devices."
Design Features: Similar to predicates.	Similar Design Features: "Similar to predicates."
Sterilization: Same as predicates.	Same Sterilization: "Same as BioPro predicate (K061798 and K041595)."
Mechanical Performance: Equivalent to predicate components (demonstrated through engineering analysis).	Equivalent through Engineering Analysis: "Engineering analysis was conducted to demonstrate substantial equivalence to the OrthoPediatrics Pedi-Plates predicate components." This implies the device performs mechanically at least as well as the predicate for its intended use.
Cleaning and Endotoxin Testing: Successful.	Successful Testing: "Cleaning testing, including endotoxin testing, was performed."
No New Questions of Safety and Effectiveness: Differences from predicates do not raise new concerns.	No New Questions: "Any differences do not raise new questions of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Clinical Data): None required or performed.
Data Provenance: Not applicable for clinical data. For non-clinical data (engineering tests), the provenance would be internal laboratory testing by WishBone Medical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No clinical test set with human-established ground truth was reported or required for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a physical implant (Guided Growth System), not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and AI-related effectiveness metrics are not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the purposes of this 510(k) submission, the "ground truth" for substantial equivalence was established by:
- Predicate Device Characteristics: The characteristics (intended use, indications, materials, design, sterilization) of the legally marketed predicate devices (OrthoPediatrics Pedi-Plates, Orthofix Guided Growth System, BioPro Go-EZ Screw, BioPro Toe MP Joint) served as the primary reference point.
- Engineering Standards: Compliance with recognized industry standards such as ASTM F138 (for 316-stainless steel) and ASTM F136 (for Ti-6Al-4V Titanium alloy) for material composition and biocompatibility.
- Laboratory Testing Results: The results of the engineering analysis (mechanical performance) and cleaning/endotoxin testing.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in that context.

9. How the Ground Truth for the Training Set was Established

Not applicable. (See point 8.)

Summary

{0}------------------------------------------------

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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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, 46582Phone: +1 (574) 306-4006Fax: (574) 376-4746Establishment Registration Number: 3013680140
Contact:	Mary WetzelChief Operating OfficerMaryWetzel@wishbonemedical.com
Date:	February 13, 2018
Subject Device:	Trade Name: WishBone Medical Guided Growth SystemCommon name(s): bone plate, bone screwClassification Name:OBT Single/multiple component metallic bone fixation appliancesand accessories. (CFR 888.3030)
Primary Predicate Device:	OrthoPediatrics Pedi-Plates (K090666, K171173)
Additional Legally Marketedpredicates:	Orthofix Guided Growth System Eight-Plate, Quad-Plate (K110805)WishBone Medical Plate And Screw System (K180736)BioPro Go-EZ Screw (K081149) - for packaging and sterilizationBioPro Toe MP Joint (K041595) – for packaging and sterilization
Device Description:	The WishBone Medical Guided Growth System is intended to be usedfor the express and sole purpose of redirecting the angle of growth oflong bone(s). This is useful for gradually correcting angular deformitiesin growing children. The WishBone Medical Guided Growth Systemimplants are made of a 316-stainless steel material in compliance ofASTM F138, and Ti-6Al-4V Titanium alloy compliant to ASTM F136. 316stainless steel and Ti-Al-4V are biocompatible materials that are readilyavailable 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 TechnicalCharacteristics:	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 PerformanceData (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 EquivalenceConclusion:	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

{4}------------------------------------------------

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.

Regulation Number and Section

§ 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.