(30 days)
No
The summary describes a mechanical orthopedic implant system (plates and screws) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is indicated for temporary stable internal fixation of femoral osteotomies and fractures, which is a therapeutic intervention for structural support and healing of bones.
No
The device is a system of plates and screws intended for the surgical fixation of bones, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Plate and Screw System" composed of "316- Stainless Steel material" and supplied in "sterile packaging configurations," indicating it is a physical hardware device. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The WishBone Medical Plate and Screw System is a surgical implant used for internal fixation of bones. It is physically placed inside the patient's body during surgery.
- Intended Use: The intended use is for the treatment of fractures and deformities by providing stable internal fixation of bones. This is a therapeutic intervention, not a diagnostic test.
The description clearly indicates a device used for surgical treatment, not for testing biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavice, scapula, humerus, ulna, radius, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, calcaneus
Indicated Patient Age Range
pediatric and adult patients, infant, child, and adolescent pediatric subgroups and small stature adult patients
Intended User / Care Setting
Not Found
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 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
- 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:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
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
1
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
2
Indications for Use
510(k) Number (if known) K230527
Device Name
WishBone Medical Plate and Screw System
Indications for Use (Describe)
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.
| 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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3
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 Drive |
| Warsaw, IN 46582 | |
| Phone Number | (574) 306-4006 |
| Establishment Registration | |
| Number | 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 and |
| accessories (Primary) | |
| Smooth or threaded metallic bone fixation fastener | |
| Regulatory Classification | II |
| 510(k) Review Panel | Orthopedic Devices (OHT6), Division of Restorative, Repair and Trauma |
| Devices (DHT6C) | |
| Regulation | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener. |
| 21 CFR 888.3030 – Single/multiple component metallic bone fixation | |
| appliances and accessories (Primary) | |
| Product Code(s) | HRS, HWC |
| Legally marketed device to | |
| which equivalence is claimed | Wishbone Medical Plates and Screw System-3.0mm Screws and 7-hole |
| Straight 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 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). | |
| Intended Use of the Device | The WishBone Medical Plate and Screw System is intended for fixation |
| of fractures. | |
| Indications for Use | The WishBone Medical Plate and Screw System is indicated for pediatric |
| and 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, 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 | |
| indicated for use in infant, child, and adolescent pediatric subgroups and | |
| small stature adult patients. |
4
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
5
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.