(233 days)
K082320- Wright ™ Compression Screw
No
The device description and performance studies focus on the mechanical properties and intended use of a bone screw, with no mention of AI or ML technologies.
No.
The device is indicated for fixation and reconstruction of bone, which are considered surgical procedures rather than therapeutic in the medical device context.
No
Explanation: The MICA™ Screw is a device used for bone fixation and reconstruction, which is a treatment rather than a diagnostic process. It does not identify or characterize diseases or conditions.
No
The device description clearly states that the MICA™ Screws are fully threaded, cannulated screws made from titanium alloy, indicating a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MICA™ Screw is for the "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 a "fully threaded, cannulated screw made from titanium alloy" intended for use in bone. This is a physical implant.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
The MICA™ Screw is a surgical implant used for mechanical support and fixation within the body, not for testing samples outside the body.
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
Product codes
HWC
Device Description
The MICA™ Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device. All MICA™ Screws are fully threaded, cannulated screws made from titanium alloy.
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
Torsional Testing:
- Torsional Testing - Insertion Torque, Removal Torque, Ultimate Torque
- Acceptance Value/Criteria: Ultimate Torque must exceed insertion torque and removal torque by a safety factor
- Results: Acceptable
Engineering Analysis:
- Engineering Analysis - Axial Pullout Force, Bending Strength
- Acceptance Value/Criteria: Comparable to the predicate device design
- Results: Acceptable
Bacterial Endotoxins Testing:
- Bacterial Endotoxins Testing
- Acceptance Value/Criteria: ≤20EU/device
- Results: Acceptable
Key Metrics
Not Found
Predicate Device(s)
K082320- Wright ™ Compression Screw
Reference Device(s)
Not Found
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other to create a sense of depth. The profiles are connected to a symbol that resembles a bird's wing or a flowing ribbon. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. Tara Conrad Regulatory Affairs Specialist II 1023 Cherry Rd Memphis. Tennessee 38117
April 13, 2017
Re: K162353
Trade/Device Name: MICA 10 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: March 13, 2017 Received: March 17, 2017
Dear Ms. Conrad:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K162353
Device Name MICA™ 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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K162353 Page 1 of 2
Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
018679971 mt.com
Image /page/3/Picture/4 description: The image shows the logo for Wright, a company that focuses on excellence. The logo features two overlapping trapezoids, one red and one orange, to the left of the word "WRIGHT" in red, block letters. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, sans-serif font.
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 MICA™ Screw System.
| 1. Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|------------------------------------|------------------------------------------------------------------------------------------------|
| Date: | April 12, 2017 |
| K Number: | K162353 |
| Contact Person: | Tara Conrad
Regulatory Affairs Specialist II
Office (901) 867-4367
Fax (901) 867-4190 |
| 2. Proprietary Name: | MICA TM 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 |
| 3. Predicate Device: | K082320- Wright TM Compression Screw |
4. Device Description
The MICA™ Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device. All MICA™ Screws are fully threaded, cannulated screws made from titanium alloy.
5. Intended Use and 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
4
- · 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
6. Technological Characteristics Comparison
The MICA Screw System has similar indications, utilizes similar instrumentation, is made from identical materials, and has identical sterilization methods when compared to the legally marketed predicate devices
7. Substantial Equivalence- Non-Clinical Evidence
| Validation and/or
| Verification Method | Acceptance Value/Criteria | Results |
|---|---|---|
| Torsional Testing |
- Insertion Torque
- Removal Torque
- Ultimate Torque | Ultimate Torque must exceed
insertion torque and removal
torque by a safety factor | Acceptable |
| Engineering Analysis - Axial Pullout Force
- Bending Strength | Comparable to the predicate
device design | Acceptable |
| Bacterial Endotoxins Testing | ≤20EU/device | Acceptable |
8. Substantial Equivalence- Clinical Evidence
N/A
9. Substantial Equivalence- Conclusions
The design characteristics of the subject devices do not raise any different 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 systems and are substantially equivalent.