(232 days)
Not Found
No
The device description and intended use are for a physical screw used for bone fixation. There is no mention of software, algorithms, or any technology that would incorporate AI/ML.
No.
The device is used to fix bone fractures or for bone reconstruction, which is a treatment rather than a diagnostic or monitoring function.
No
The device is a screw used for fixation and reconstruction of bones, not for diagnosing conditions. Its intended use is for surgical procedures to repair or stabilize bones, not to provide diagnostic information.
No
The device description clearly states that the device is a physical screw manufactured from titanium alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of bone fractures or for bone reconstruction." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "fully threaded, cannulated screws manufactured from titanium alloy." This is a physical implant 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 compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The MICA™ Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Mono or Bi-Cortical osteotomies in the foot or hand
- Distal or Proximal metatarsal or metacarpal osteotomies
- Weil osteotomy
- Fusion of the first metatarsophalangeal joint and interphalangeal joint
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Akin type osteotomy
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- Calcaneus/cuboid arthrodesis
- Talar/navicular arthrodesis
The PROSTEPTM MICATM Screw System is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Mono or Bi-Cortical osteotomies in the foot or hand
- Distal or Proximal metatarsal or metacarpal osteotomies
- Weil osteotomy
- Fusion of the first metatarsophalangeal joint and interphalangeal joint
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Akin type osteotomy
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus ● varus primus
- Calcaneus/cuboid arthrodesis
- Talar/navicular arthrodesis
Product codes
HWC
Device Description
The PROSTEP™ MICA™ Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the device. MICA™ Screws are fully threaded, cannulated screws manufactured from titanium alloy. The screws are available in diameters of 3-4 mm in various lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot or hand
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)
Substantial Equivalence - Non-Clinical Evidence:
Packaging Integrity and Shelf-Life (As established in ISO 11607:2006) - Pass
Sterilization (As established in ISO 11137-2:2013) - Pass
Bacterial Endotoxins Testing (
§ 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.
0
Image /page/0/Picture/0 description: The image shows 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.
January 11, 2019
Wright Medical Technology, Inc. Val Myles Senior Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K181377
Trade/Device Name: PROSTEP MICA Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: December 12, 2018 Received: December 14, 2018
Dear Val Myles:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K181377
Device Name PROSTEPTM MICATM Screw System
Indications for Use (Describe)
The MICA™ Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Mono or Bi-Cortical osteotomies in the foot or hand
- · Distal or Proximal metatarsal or metacarpal osteotomies
- · Weil osteotomy
- · Fusion of the first metatarsophalangeal joint and interphalangeal joint
- · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- · Akin type osteotomy
- · Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- · Calcaneus/cuboid arthrodesis
- · Talar/navicular arthrodesis
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 shows the logo for Wright, a company that focuses on excellence. The logo consists of two overlapping trapezoids on the left, followed by the word "WRIGHT" in large, bold letters. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in smaller letters. The logo is simple and modern, and the use of gray gives it a professional look.
1023 Cherry Road Memphis, TN 38117 wright.com
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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 PROSTEP™ MICA™ Screw System.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|------------------------------------|----------------------------------------------------------------------------------|
| Date: | May 11, 2018 |
| Contact Person: | Val Myles
Sr. Regulatory Affairs Specialist |
| (a)(2). Proprietary Name: | PROSTEP™ MICAT™ Screw System |
| Common Name: | Cannulated Bone Screw |
| Classification Name and Reference: | 21 CFR 888.3040- Class II- Smooth or threaded
metallic bone fixation fastener |
| Device Product Code, Device Panel: | HWC – Orthopedic |
| (a)3. Predicate Device: | K162353 - MICA Screw System |
(a)(4). Device Description
The PROSTEP™ MICA™ Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the device. MICA™ Screws are fully threaded, cannulated screws manufactured from titanium alloy. The screws are available in diameters of 3-4 mm in various lengths.
(a)(5). Intended Use
The MICA" Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Mono or Bi-Cortical osteotomies in the foot or hand
- . Distal or Proximal metatarsal or metacarpal osteotomies
- Weil osteotomy
- . Fusion of the first metatarsophalangeal joint and interphalangeal joint
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- . Akin type osteotomy
4
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus ● varus primus
- . Calcaneus/cuboid arthrodesis
- . Talar/navicular arthrodesis
(a)(6). Technological Characteristics Comparison
The MICA™ Screws are substantially equivalent in indications, dimensions, and materials when compared to the legally marketed predicate device. The modified packaging configuration of the subject device meets the relevant packaging and sterility standards (listed below) and is therefore substantially equivalent to the predicate.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
| Validation and/or Verification
| Method | Acceptance Value/Criteria | Results |
|---|---|---|
| Packaging Integrity and Shelf-Life | As established in ISO 11607:2006 | Pass |
| Sterilization | As established in ISO 11137-2:2013 | Pass |
| Bacterial Endotoxins Testing | ≤ 20EU/device | Pass |
(b)(2). Substantial Equivalence- Clinical Evidence
N/A
(b)(3). Substantial Equivalence- Conclusions
The design 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 can be expected to perform at least as well as the predicate devices.