The WishBone Medical Plate and Screw System is indicated for pediatric and adult patients of the clavice, scapula, humerus, ulna, radius, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, and treatment of the calcaneus, and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis.

The system includes Femoral Locking Plates and Screws, which are in infant, child, and adolescent pediatric subgroups and small stature adult patients.

Device Description

The WishBone Medical Femoral Locking Plate System was designed to address deformity correction in the proximal and distal femur where plating is an option for correction. It is intended to be used for temporary stable internal fixation of femoral osteotomies and fractures in pediatric patients. The system consists of two plate sizes, 3.5mm and 4.5mm, which align with the corresponding screw sizes, and are offered in varying lengths based on the quantity of screw holes needed. Plates have three screw holes in the "head" of each plate, plus 3, 4, 6, 8, or 10 screw holes in the shaft of the plates, based on plate configuration. Plates are also offered in varying angles ranging from 85° to 140°, with differing offsets and flares. These variations allow surgeons to best match the presenting patient's anatomy. New 3.5mm and 4.5mm locking and non-locking cortical screws are being added to the system for use with these new plates.

The subject Femoral Locking Plate System implants are composed of 316- Stainless Steel material (ASTM F138-19) and are supplied in one of two single-use sterile packaging configurations based on plate size: sterile packed Tyvek-covered trays or Nylon pouches, each with a double sterile barrier.

The Femoral Locking Plate System is a line extension of the WishBone Medical Plate and Screw System (K180736 & K213498).

AI/ML Overview

The provided regulatory submission for the WishBone Medical Plate and Screw System (K230527) does not include acceptance criteria or the study data that typically demonstrates medical device performance against such criteria in the context of diagnostic or AI-driven devices.

This submission is for a mechanical orthopedic implant (plates and screws), and the "acceptance criteria" discussed are primarily related to ensuring the new device (Femoral Locking Plate System) is substantially equivalent to previously cleared predicate devices based on design, materials, manufacturing processes, and mechanical performance.

Here's why the requested information regarding acceptance criteria and performance studies in the context of an AI/diagnostic device is not present:

Device Type: This is a Class II orthopedic implant (metallic bone fixation appliances). The clearance process for such devices heavily relies on demonstrating mechanical equivalence, biocompatibility, and sterilization validation compared to existing, legally marketed predicate devices. It is not an AI/diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC based on analyzing clinical data.
"Acceptance Criteria" for this device: For this type of device, "acceptance criteria" are implied through the non-clinical performance testing. These are typically engineering specifications and thresholds (e.g., specific torque values for screw torsion, load limits for bend tests) that the device must meet to ensure its mechanical integrity and safety. These are not explicitly laid out in a table in the provided public summary.
"Study that proves the device meets the acceptance criteria": This refers to the non-clinical performance testing mentioned.

Therefore, many of the specific questions (like sample size for test set, data provenance, ground truth, MRMC studies, AI performance, etc.) are not applicable to this type of medical device submission.

However, I can extract the relevant information that is present in the document regarding the justification for substantial equivalence.

Summary of Acceptance Criteria and Performance (Based on Device Type and Available Information)

Given that this is a mechanical orthopedic implant, "acceptance criteria" are implied by successful performance in biomechanical and material tests. The document states that engineering analyses and testing were conducted to reaffirm substantial equivalence, meaning the device met the established performance standards of the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
Performance comparable to predicate in Screw Torsion	"Engineering analyses and testing were conducted on the subject Femoral Locking Plate System to reaffirm substantial equivalence with the predicate devices, addressing: Screw Torsion." (Implies successful completion and comparable results)
Performance comparable to predicate in Screw Pull-out	"Engineering analyses and testing were conducted... addressing: Screw Pull-out." (Implies successful completion and comparable results)
Performance comparable to predicate in Screw Insertion and Removal	"Engineering analyses and testing were conducted... addressing: Screw Insertion and Removal." (Implies successful completion and comparable results)
Performance comparable to predicate in Four Point Dynamic Bend Test of Femoral Plates	"Engineering analyses and testing were conducted... addressing: Four Point Dynamic Bend Test of Femoral Plates." (Implies successful completion and comparable results)
Material/Design Integrity:
Appropriate Laser Etch Location	"Engineering analyses and testing were conducted... addressing: Laser Etch Location Assessment." (Implies meeting design specifications)
Biocompatibility	"Engineering analyses and testing were conducted... addressing: Biocompatibility Risk Assessment." (Implies meeting established standards for medical device materials, confirmed by using 316-Stainless Steel, ASTM F138-19)
Sterilization Efficacy (SAL)	"Engineering analyses and testing were conducted... addressing: Sterilization Validation." (Implies achieving specified Sterility Assurance Level [SAL] and using the same method/dose as predicate.)
Functional Equivalence:
Equivalent Intended Use, Indications for Use, Design Features	"The subject system and predicate systems have the same intended use. No new or increased risks have been identified. The subject system and predicate systems have similar intended use. No new or increased risks have been identified. The subject device design is comparable to the predicate system. No new or increased risks have been identified."

Detailed Breakdown for AI/Diagnostic Device Questions (Not Applicable or Information Not Provided Herein):

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not Applicable. This is a mechanical device, not a diagnostic or AI device that uses clinical data for performance evaluation in this context. The "test set" here refers to the physical devices subjected to mechanical and material testing, not a dataset of patient images or readings.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not Applicable. Ground truth, in the context of clinical data interpretation, is not relevant for this mechanical device. The "ground truth" for mechanical testing would be the accepted engineering standards and specifications.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not Applicable. Adjudication methods are used for resolving disagreements in expert interpretations of clinical data, which is not part of this submission type.
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: Not Applicable. This is not an AI-assisted diagnostic or interpretation device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not Applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not Applicable. For mechanical performance, the "ground truth" is adherence to established ASTM standards and comparable performance to predicate devices.
The sample size for the training set: Not Applicable. There is no "training set" in the AI sense for this device.
How the ground truth for the training set was established: Not Applicable.

Conclusion:

The provided document details a 510(k) submission for a mechanical bone plate and screw system. The "acceptance criteria" and "studies" are related to mechanical engineering tests, material science, and sterilization validation to demonstrate substantial equivalence to predicate devices, rather than the performance metrics typically associated with AI or diagnostic clinical performance studies.

Summary

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March 29, 2023

FDA U.S. FOOD & DRUG
ADMINISTRATION

WishBone Medical, Inc. Kayla Johnston Regulatory Affairs Associate 100 Capital Drive Warsaw, Indiana 46582

Re: K230527

Trade/Device Name: WishBone Medical Plate and Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: February 24, 2023 Received: February 27, 2023

Dear Kayla Johnston:

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

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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 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,

Shumaya Ali-S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230527

Device Name

WishBone Medical Plate and Screw System

Indications for Use (Describe)

The system includes Femoral Locking Plates and Screws, which are in infant, child, and adolescent pediatric subgroups and small stature adult patients.

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 consists of a blue circle with a white wishbone inside, followed by the text "WishBone" in a larger, darker font, and "MEDICAL" in a smaller, lighter font below it. The logo is clean and professional, suggesting a medical or healthcare-related company.

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the WishBone Medical Plate and Screw System Femoral Locking Plate System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document The Special 510(k) Program, issued September 13, 2019.

SUBMITTER INFORMATION
Applicant	WishBone Medical, Inc.
Address	100 Capital DriveWarsaw, IN 46582
Phone Number	(574) 306-4006
Establishment RegistrationNumber	3013680140
Name of Contact Person	Kayla Johnston
Date Prepared	March 29, 2023
NAME OF DEVICE
Trade or Proprietary Name	Wishbone Medical Plate & Screw System
Common or usual name	Plate, Fixation, Bone (Primary)Screw, Fixation, Bone
Classification Name	Single/multiple component metallic bone fixation appliances andaccessories (Primary)Smooth or threaded metallic bone fixation fastener
Regulatory Classification	II
510(k) Review Panel	Orthopedic Devices (OHT6), Division of Restorative, Repair and TraumaDevices (DHT6C)
Regulation	21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener.21 CFR 888.3030 – Single/multiple component metallic bone fixationappliances and accessories (Primary)
Product Code(s)	HRS, HWC
Legally marketed device towhich equivalence is claimed	Wishbone Medical Plates and Screw System-3.0mm Screws and 7-holeStraight Fibula Plate (K213489)
Other Predicate	Wishbone Medical Plates and Screws System (K180736)DePuy Synthes - Synthes Pediatric LCP Plates (K112085)
Device Description	The WishBone Medical Femoral Locking Plate System was designed toaddress deformity correction in the proximal and distal femur where platingis an option for correction. It is intended to be used for temporary stableinternal fixation of femoral osteotomies and fractures in pediatric patients.The system consists of two plate sizes, 3.5mm and 4.5mm, which align withthe corresponding screw sizes, and are offered in varying lengths based onthe quantity of screw holes needed. Plates have three screw holes in the"head" of each plate, plus 3, 4, 6, 8, or 10 screw holes in the shaft of theplates, based on plate configuration. Plates are also offered in varying anglesranging from 85° to 140°, with differing offsets and flares. These variations
	allow surgeons to best match the presenting patient's anatomy. New 3.5mmand 4.5mm locking and non-locking cortical screws are being added to thesystem for use with these new plates.
	The subject Femoral Locking Plate System implants are composed of 316-Stainless Steel material (ASTM F138-19) and are supplied in one of twosingle-use sterile packaging configurations based on plate size: sterilepacked Tyvek-covered trays or Nylon pouches, each with a double sterilebarrier.
	The Femoral Locking Plate System is a line extension of the WishBoneMedical Plate and Screw System (K180736 & K213498).
Intended Use of the Device	The WishBone Medical Plate and Screw System is intended for fixationof fractures.
Indications for Use	The WishBone Medical Plate and Screw System is indicated for pediatricand adult patients for 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, andfixation of bones that have been surgically prepared (osteotomy) forcorrection of deformity or arthrodesis.
	The system includes Femoral Locking Plates and Screws, which areindicated for use in infant, child, and adolescent pediatric subgroups andsmall stature adult patients.

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Image /page/4/Picture/1 description: The image contains the logo for WishBone Medical. The logo consists of a blue circle with a white wishbone inside of it on the left. To the right of the circle is the text "WishBone" in a larger, darker font, with the word "MEDICAL" underneath in a smaller, lighter font.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: The subject system and predicate systems have the same intended use. No new or a. increased risks have been identified.
Indications for Use: The subject system and predicate systems have similar intended use. No new b. or increased risks have been identified.
Materials: The subject device is manufactured from the same material as the predicate. Therefore, C. no new or increased risks have been identified.
d. Design Features: The subject device design is comparable to the predicate system. No new or increased risks have been identified.
Sterilization: The subject and predicate systems have the same sterilization method and dose and e. sterility assurance level (SAL). No new or increased risks have been identified.

PERFORMANCE DATA NON-CLINICAL TESTING

Engineering analyses and testing were conducted on the subject Femoral Locking Plate System to reaffirm substantial equivalence with the predicate devices, addressing:

· Screw Torsion

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Image /page/5/Picture/1 description: The image shows the logo for WishBone Medical. The logo consists of a blue circle with a white wishbone inside, followed by the text "WishBone" in a sans-serif font. Below "WishBone" is the word "MEDICAL" in a smaller, sans-serif font.

Screw Pull-out
· Screw Insertion and Removal
· Four Point Dynamic Bend Test of Femoral Plates
· Laser Etch Location Assessment
· Biocompatibility Risk Assessment
· Sterilization Validation

CLINICAL TESTING

Clinical testing was not deemed necessary to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject device has the same intended use and indications as the predicate Wishbone Medical Plate and Screw System (K213489 and K180736) and Synthes Pediatric LCP Plates (K112085). The subject plate also has comparable technological characteristics to the predicate device systems, and the performance data and analyses demonstrate that any differences do not raise new questions of safety and effectiveness. Therefore, we conclude that the proposed device is at least as safe and performs substantially equivalent or better than the legally marketed predicate devices.

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.