(128 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a bone staple implant, with no mention of AI or ML.
No.
The device is a bone staple implant system used for fracture fixation and joint arthrodesis, which is a structural implant rather than a therapeutic device that delivers treatment.
No
Explanation: The device is intended for fracture fixation and joint arthrodesis, which are treatments, not diagnostic processes.
No
The device description explicitly states it consists of bone staple implants and instruments for implantation, which are physical hardware components.
Based on the provided information, the FuseForce™ Flex Dynamic Compression System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for fracture fixation, and joint arthrodesis of the foot and ankle." This describes a surgical procedure performed directly on the patient's body to treat a condition.
- Device Description: The device consists of "bone staple implants" and "instruments for implantation." These are physical devices used in surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Reagents, calibrators, or controls
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The FuseForce™ Flex Dynamic Compression System is a surgical implant used for mechanical fixation and compression within the body.
N/A
Intended Use / Indications for Use
The FuseForce™ Flex Dynamic Compression System is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.
Product codes
JDR
Device Description
The FuseForce™ Flex Dynamic Compression System consists of bone staple implants with two-leg and four-leg configurations. The system features low-profile and wide bridges, as well as multiple leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant and instruments for implantation. The implant is designed to provide compression to facilitate bone fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle
Indicated Patient Age Range
Not Found
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)
Performance testing and engineering analysis demonstrated substantial equivalence to the predicate device in the following:
- Static bending, bending fatigue, and pullout strength (per ASTM F564) ●
- Corrosion resistance (per ASTM F2129 and ASTM F3306)
- Bacterial endotoxin (per ANSI/AAMI ST72:2019)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
May 7, 2021
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle and text. To the right of that is the FDA logo, which includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Wright Medical Jonathan Dimotta Regulatory Affairs Specialist II 1023 Cherry Road Memphis, Tennessee 38117
Re: K203832
Trade/Device Name: FuseForce™ Flex Dynamic Compression System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: March 30, 2021 Received: March 31, 2021
Dear Jonathan Dimotta:
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 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
1
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 mediation-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,
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K203832
Device Name FuseForce™ Flex Dynamic Compression System
Indications for Use (Describe)
The FuseForce™ Flex Dynamic Compression System is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Image /page/3/Picture/1 description: The image contains the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, followed by the word "WRIGHT" in red, and the words "FOCUSED EXCELLENCE" in gray below. The Wright logo is a corporate logo for a business.
1023 Cherry Road Memphis, TN 38117 wright.com
510(k) SUMMARY
In accordance with the Food and Drug Administration rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the FuseForce™ Flex Dynamic Compression System.
| (a)(1) MANUFACTURER
| IDENTIFICATION | |
|---|---|
| Submitted By: | Wright Medical Technology, Inc. |
| 1023 Cherry Road | |
| Memphis, TN 38117 | |
| Date: | May 3, 2021 |
| Contact Person: | Jonathan DiMotta |
Regulatory Affairs Specialist Office: (901) 867-4121 Fax: (901) 867-4190
(a)(2) SUBJECT DEVICE INFORMATION
| Proprietary Name: | FuseForce™ Flex Dynamic Compression System |
|---|---|
| Common Name: | Bone Staple |
| Classification Name & Reference: | 21 CFR 888.3030 – Class II |
| Device Product Code & Panel: | JDR – Orthopedic |
(a)(3) PREDICATE DEVICE INFORMATION
| FuseForce™ Implant System | K124045 |
|---|---|
| Memodyn Staple | K161587 (reference) |
(a)(4) DEVICE DESCRIPTON
The FuseForce™ Flex Dynamic Compression System consists of bone staple implants with two-leg and four-leg configurations. The system features low-profile and wide bridges, as well as multiple leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant and instruments for implantation. The implant is designed to provide compression to facilitate bone fusion.
(a)(5) INTENDED USE
The FuseForce™ Flex Dynamic Compression System is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.
4
The indications for the subject devices are substantially equivalent to those cleared under K124045. The predicate devices are indicated for use in the foot and hand, while the subject devices are indicated for the foot and ankle. The word "ankle" was included in the indications to provide additional clarity to the end user. As the subject devices' intended use are identical with the exception of use in the hand, the indications are substantially equivalent to the predicate system.
(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON
Compared to the legally marketed primary predicate, the subject FuseForce™ Flex Dynamic Compression System has a similar design, indications for use, and performance characteristics. The system features the same principles of operation for bone fixation and sterilization method as the predicate system. The subject and predicate are manufactured from the same nitinol material (ASTM F2063) and share similar features such as their wingless design and legs with teeth. The subject bone staples feature wider bridges while maintaining similar bridge and leg lengths as the predicate devices. The subject system adds sizes with longer bridges, longer leg lengths, and 4-leg staples when compared to the predicate to further accommodate varying patient anatomy.
(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE
Performance testing and engineering analysis demonstrated substantial equivalence to the predicate device in the following:
- Static bending, bending fatigue, and pullout strength (per ASTM F564) ●
- Corrosion resistance (per ASTM F2129 and ASTM F3306)
- Bacterial endotoxin (per ANSI/AAMI ST72:2019)
(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE
N/A
(b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS
The design and performance characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices are considered substantially equivalent to the predicate device.