(28 days)
The WishBone Bone 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 (osteotion 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.
The purpose of this subject 510(k) is to introduce 4.0mm diameter cannulated screws and washers to the bone plate and screw system cleared under K180736.
This document describes a 510(k) premarket notification for the WishBone Medical Plate and Screw System. It is a submission for an orthopedic device, specifically bone plates and screws.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The submission refers to acceptance criteria, but doesn't explicitly state a table with quantitative values for each criterion and the device's performance against them. Instead, it indicates that the device met certain standards.
| Acceptance Criterion (Reference) | Reported Device Performance |
|---|---|
| Predicted Shear Failure: Performance criteria for pullout strength defined within the FDA guidance document "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway". | Confirmed pullout strength met performance criteria defined within the FDA guidance document. |
| Torsional Strength: Compared torsional strength of the screw shafts to legally marketed predicate cannulated screws per ASTM F543-17. | Torsional strength of the screw shafts was compared to predicate cannulated screws. (Implied that it met or was comparable to the predicate, as a conclusion of substantial equivalence was reached). |
| Breaking Torque of 4.0mm Cannulated Screws at the Hexalobe Drive Feature: Torsional yield strength as defined in the FDA guidance document. | Confirmed the screw head meets the torsional yield strength as defined in the FDA guidance document. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of number of screws or plates tested. The document mentions "Engineering analysis and mechanical testing," but does not provide specific sample numbers for these tests.
- Data Provenance: The studies were non-clinical engineering and mechanical tests performed to demonstrate compliance with standards (ASTM F543-17) and FDA guidance documents. This indicates the testing was likely conducted in a controlled lab environment. There is no information regarding country of origin for the data, nor whether it was retrospective or prospective, as these terms typically apply to clinical studies.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable as the studies were non-clinical mechanical tests, not clinical studies involving human patients or expert interpretation of medical data (like imaging). Therefore, no "ground truth" derived from expert consensus was required for this particular submission.
4. Adjudication Method for the Test Set
This information is not applicable as the studies were non-clinical mechanical tests. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies where multiple experts evaluate cases and discrepancies need to be resolved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/radiology devices where human readers' performance with and without AI assistance is evaluated. The WishBone Medical Plate and Screw System is a physical orthopedic implant, not an AI diagnostic or assistive device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study (in the context of an algorithm's performance without human interaction) was not done. This is because the device in question is a physical medical implant, not an algorithm or AI software.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established by industry standards (ASTM F543-17) and performance criteria defined within FDA guidance documents for metallic bone screws and washers. These define the expected mechanical properties and failure limits.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical implant, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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December 23, 2020
WishBone Medical, Inc. Mary Wentorf Executive VP, Product Development, QA/RA 100 Capital Drive Warsaw, Indiana 46582
Re: K203467
Trade/Device Name: WishBone Medical Plate and Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC. HTN Dated: November 23, 2020 Received: November 25, 2020
Dear Mary Wentorf:
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.
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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 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 (OS) 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, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K203467
Device Name
WishBone Bone Plate and Screw System
Indications for Use (Describe)
The WishBone Bone 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 (osteotion 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.
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 modern, sans-serif font. Underneath "WishBone", the word "MEDICAL" is written in smaller, block letters.
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 Bone Plate and Screw System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, "The Special 510(k) Program", issued on September 13, 2019.
1. SUBMITTER
| Applicant | WishBone Medical, Inc. |
|---|---|
| Establishment | 3013680140 |
| Registration Number | |
| Contact | Mary Wentorf |
| Date Prepared | 11/23/2020 |
2. SUBJECT DEVICE
| Name of Device | WishBone Medical Plate and Screw System |
|---|---|
| Common Name | Bone Plates and Bone Screws |
| Classification Name | Screw, Fixation, Bone (21 CFR 888.3040)Washer, Bolt Nut (21 CFR 888.3030) |
| Product Code | HWCHTN |
| Regulatory Class | II |
| 510(k) Review Panel | Orthopedic Devices (OHT6) |
3. PREDICATE DEVICE(S)
| Primary Predicate | K180736 - WishBone Bone Plate and Screw System |
|---|---|
| Reference Device(s) | K123890 – Acumed Cannulated Screw System |
4. DEVICE DESCRIPTION
The purpose of this subject 510(k) is to introduce 4.0mm diameter cannulated screws and washers to the bone plate and screw system cleared under K180736.
5. INDICATIONS FOR USE
The WishBone Medical Plate and Screw System is used for pediatric and adult patients as indicated for pelvic, small and long bone fracture 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.
6. SUMMARY OF TECHNICAL CHARACTERISTICS
The rationale for substantial equivalence is based on consideration of the following characteristics:
- a. Intended Use: Same as predicate
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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 word "MEDICAL" in smaller, all-caps letters underneath.
510(k) Summary
- b. Indications for Use: Same as predicate
- C. Materials: Same as predicate
- d. Design Features: Similar to predicate
- Sterilization: Same as predicate e.
7. SUMMARY OF PERFORMANCE DATA
- NON-CLINICAL: Engineering analysis and mechanical testing was conducted in a. compliance with ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws and with performance standards defined within the FDA guidance document Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway. Evaluations conducted include:
- Predicted Shear Failure - Confirmed pullout out strength met performance criteria defined with the FDA guidance document.
- Torsional Strength – Compared torsional strength of the screw shafts to legally marketed predicate cannulated screws per ASTM F543-17.
- . Breaking Torque of 4.0mm Cannulated Screws at the Hexalobe Drive Feature – Confirmed the screw head meets the torsional yield strength as defined in the FDA guidance document.
- b. CLINICAL: Clinical data was not deemed necessary for the subject device.
8. CONCLUSION
The subject device has the same intended use and indications for use as the WishBone Bone Plate and Screw System. The subject device has same/similar technological characteristics to the predicate, and the performance data and analyses demonstrates that:
- . Any differences do not raise new questions of safety and effectiveness; and
- The proposed device is at least as safe and effective as the legally marketed predicate . devices.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.