(28 days)
No
The 510(k) summary describes a bone plate and screw system, a purely mechanical device for fracture fixation. There is no mention of software, image processing, AI, ML, or any data-driven components. The performance studies are mechanical tests.
Yes
The device is described as a system for fracture fixation and fixation of surgically prepared bones, which directly addresses a medical condition to restore normal function or structure.
No
Explanation: The device is described as a "Bone Plate and Screw System" used for "fracture fixation and fixation of bones that have been surgically prepared". Its purpose is to introduce cannulated screws and washers for orthopaedic use, not to diagnose medical conditions.
No
The device description explicitly states it is a "Bone Plate and Screw System" and describes physical components (screws and washers). The performance studies also focus on mechanical testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of bone fractures and surgically prepared bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a bone plate and screw system, which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
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 (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.
Product codes
HWC, HTN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic, small and long bone, clavicle, scapula, humerus, ulna, radius, middle hand, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, calcaneus.
Indicated Patient Age Range
pediatric and adult patients
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
NON-CLINICAL: Engineering analysis and mechanical testing was conducted in 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.
CLINICAL: Clinical data was not deemed necessary for the subject device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 | HWC |
| HTN | |
| 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.