(87 days)
Not Found
No
The 510(k) summary describes a mechanical plate and screw system for bone fixation. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The performance studies are engineering analyses of mechanical properties.
Yes
The device is a Plate and Screw System used for fracture fixation and correction of deformities, which are therapeutic interventions.
No
Explanation: The device is described as a system for fracture fixation and correction of deformity, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it is a "wrought titanium alloy plate and screws," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical fixation of bones in pediatric and adult patients. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a plate and screw system made of titanium alloy. This is a physical implant used to stabilize bone fractures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device's function is purely mechanical support for bone healing.
Therefore, the WishBone Medical Plate and Screw System falls under the category of a surgical implant for orthopedic use, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Specifically, the Straight Fibula Plates are in infant, child, and adolescent pediatric subgroups and adult patients.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The WishBone Medical 7-Hole Straight Fibula Plate and WishBone Medical 3.0mm Cortical Screws and Locking Screws are wrought titanium alloy plate and screws (per ASTM F136) that are being added to the existing WishBone Medical Plate and Screw System as a line extension.
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, middle foot bones, calcaneus.
Indicated Patient Age Range
pediatric and adult patients, infant, child, and adolescent pediatric subgroups 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analyses were conducted on the WishBone Medical 7-hole Fibula Plate, and 3.0mm Cortical and Locking Screws to demonstrate substantial equivalence with the predicate device, addressing:
- Axial Pullout Strength per FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" issued December 11, 2020.
- Engineering analysis - no new worst case for Screw Torsion per ASTM F543
- Engineering analysis - no new worst case for Bending Fatigue per ASTM F382
- Engineering analysis - no new worst case for Insertion and Removal
- Engineering analysis - no new worst case for Pull-through Strength
- Engineering analysis no new worst case for Fretting and Corrosion per ASTM F897
- Engineering analysis - no new worst case for Biocompatibility Risk Assessment per ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued September 2020.
The results of engineering analyses indicate that:
- The devices performed within the intended use
- No new questions of safety or efficacy were raised
- The devices were found to be substantially equivalent to 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.
Wishbone Medical Plate and Screw System (K180736)
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
January 27, 2022
Image /page/0/Picture/11 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.
WishBone Medical, Inc. Ramakrishna Bajaj Regulatory Affairs Specialist 100 Capital Drive Warsaw, Indiana 46582
Re: K213489
Trade/Device Name: Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate 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: October 29, 2021 Received: November 1, 2021
Dear Ramakrishna Bajaj:
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,
For: 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) K213489
Device Name
WishBone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate
Indications for Use (Describe)
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.
Specifically, the Straight Fibula Plates are in infant, child, and adolescent pediatric subgroups and adult patients.
Type of Use (Select one or both, as applicable)
X 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 sans-serif font. Below "WishBone" is the word "MEDICAL" in a smaller, sans-serif font, with a wider letter spacing.
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the WishBone Medical Wishbone Plate and Screw: 3.0mm Screws and 7-Hole Straight Fibula Plate 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document Format for Traditional and Abbreviated 510(k)s, issued in September 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 | Ramakrishna Bajaj |
| Date Prepared | October 29, 2021 |
| NAME OF DEVICE | |
| Trade or Proprietary Name | WishBone Medical Plate and 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 and Rehabilitation Devices |
| Regulation | 21 CFR §888.3030 (Primary): Single/multiple component metallic bone |
| fixation appliances and accessories. | |
| 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener; | |
| Class II | |
| Product Code(s) | HRS(Primary), HWC |
| Primary Predicate Device | Wishbone Medical Plate and Screw System (K180736) |
| Device Description | The WishBone Medical 7-Hole Straight Fibula Plate and WishBone |
| Medical 3.0mm Cortical Screws and Locking Screws are wrought titanium | |
| alloy plate and screws (per ASTM F136) that are being added to the existing | |
| WishBone Medical Plate and Screw System as a line extension. | |
| Intended Use of the Device | The WishBone Medical 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 | 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. |
Specifically, the Straight Fibula Plates are intended for use in infant, child,
and adolescent pediatric subgroups and 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 on the left. To the right of the circle is the company name, "WishBone" in a larger, darker font, with "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 device and predicate systems have the same intended use. No new or a. increased risks are identified.
- Indications for Use: The subject device and predicate systems have the same intended use. No new b. or increased risks are identified
- Materials: The subject device is manufactured from the same materials. Therefore, no new or C. increased risks have been identified.
- Design Features: The subject device design is similar to the predicates. No new or increased risks d. are identified.
- e. Sterilization: The subject and predicate devices have the same sterilization method and dose. Therefore, no new or increased risks have been identified.
PERFORMANCE DATA NON-CLINICAL TESTING
Engineering analyses were conducted on the WishBone Medical 7-hole Fibula Plate, and 3.0mm Cortical and Locking Screws to demonstrate substantial equivalence with the predicate device, addressing:
- Axial Pullout Strength per FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" issued December 11, 2020.
- . Engineering analysis - no new worst case for Screw Torsion per ASTM F543
- Engineering analysis - no new worst case for Bending Fatigue per ASTM F382
- Engineering analysis - no new worst case for Insertion and Removal
- Engineering analysis - no new worst case for Pull-through Strength
- Engineering analysis no new worst case for Fretting and Corrosion per ASTM F897 ●
- . Engineering analysis - no new worst case for Biocompatibility Risk Assessment per ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued September 2020.
The results of engineering analyses indicate that:
- . The devices performed within the intended use
- . No new questions of safety or efficacy were raised
- . The devices were found to be substantially equivalent to predicate devices.
CLINICAL TESTING
Clinical testing was not deemed necessary to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
Given that the proposed device has the same intended use as the predicate. Wishbone Medical Plate and Screw System, same technological characteristics to the predicate, and given the information provided in this submission, it has been demonstrated 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 device.