(87 days)
No
The device description and performance studies focus on mechanical properties and biological compatibility, with no mention of AI or ML.
No
The device is used for fixation of an implanted anterior cruciate ligament (ACL) reconstruction, not for treating a disease or condition in itself.
No
This device is an implant used for fixation in ACL reconstruction, not for diagnosing medical conditions.
No
The device is an implantable fixation button with a continuous loop, consisting of physical components (metal button, continuous loop, pulling suture) and is provided sterile in single-use packages. It is a physical medical 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 is for "reconstructive treatment and extracortical femoral fixation of an implanted anterior cruciate ligament reconstruction." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is an "implantable fixation button with a continuous loop used for the femoral fixation of the anterior cruciate ligament (ACL) graft." This is a physical implant used to secure tissue within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The description of the MectaFix CL Fixation Button does not involve any such testing or analysis of specimens.
The device is clearly a surgical implant used for a specific orthopedic procedure.
N/A
Intended Use / Indications for Use
The MectaFix CL Fixation Button with Continuous Loop is indicated for use in reconstructive treatment and extracortical femoral fixation of an implanted anterior cruciate ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC, JDR
Device Description
The MectaFix CL Fixation Button with Continuous Loop is an implantable fixation button with a continuous loop used for the femoral fixation of the anterior cruciate ligament (ACL) graft by means of an extra-cortical suspensory fixation. It consists of a metal elongated button (Ti6AI4V ELI), a continuous loop (UHMWPE) ranging in length from 15 mm to 60 mm to be coupled with the graft, and a pulling suture (UHMWPE) to pull the construct through the prepared bone tunnel and to subsequently flip the button after passing the femoral lateral cortex. The MectaFix CL Fixation Button with Continuous Loop implants are provided sterile and are provided in single-use packages.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, anterior cruciate ligament
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)
Non-Clinical Studies:
- cyclic loading
- tensile strength per ASTM D2256/D2256M-10
- Cadaver testing
- Sterilization validation
- Shelf-life testing
- Pyrogenicity
- Bacterial Endotoxin Test (LAL test) was conducted according to European o Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination
- the subject devices are not labeled as non-pyrogenic or pyrogen free
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.
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
§ 888.3040 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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February 10, 2020
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K193165
Trade/Device Name: MectaFix CL Fixation with Continuous Loop Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, HWC, JDR Dated: November 14, 2019 Received: November 15, 2019
Dear Chris Lussier:
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
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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 (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 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,
Laura C. Rose, PhD Acting 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
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Indications for Use
510(k) Number (if known) K193165
Device Name
MectaFix CL Fixation Button with Continuous Loop
Indications for Use (Describe)
The MectaFix CL Fixation Button with Continuous Loop is indicated for use in reconstructive treatment and extracortical femoral fixation of an implanted anterior cruciate ligament reconstruction.
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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2.0 510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Date Prepared: November 12, 2019 Date Revised: January 28, 2020
II. Device
| Device Proprietary Name: | MectaFix CL Fixation Button with Continuous Loop |
|---|---|
| Common or Usual Name: | Suture retention device, Non-absorbable surgical suture |
| Classification Name: | Fastener, Fixation, Non-degradable, Soft tissue, Non-absorbable surgical suture |
| Product Codes: | MBI (primary), HWC (secondary), JDR (secondary) |
| Regulation Number: | 21 CFR 888.3040, 21 CFR 888.3030 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
-
. Endobutton Continuous Loop, K081098, Smith & Nephew, Inc., Endoscopy Division
The following device is referenced in the submission: -
MectaLock Ti Suture Anchor, K191300, Medacta International SA
IV. Device Description
The MectaFix CL Fixation Button with Continuous Loop is an implantable fixation button with a continuous loop used for the femoral fixation of the anterior cruciate ligament (ACL) graft by means of an extra-cortical suspensory fixation. It consists of a metal elongated button (Ti6AI4V ELI), a continuous loop (UHMWPE) ranging in length from 15 mm to 60 mm to be coupled with the graft, and a pulling suture (UHMWPE) to pull the construct through the prepared bone tunnel and to subsequently flip the button after passing the femoral lateral cortex.
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The MectaFix CL Fixation Button with Continuous Loop implants are provided sterile and are provided in single-use packages.
Indications for Use V.
The MectaFix CL Fixation Button with Continuous Loop is indicated for use in reconstructive treatment and extracortical femoral fixation of an implanted anterior cruciate ligament reconstruction.
VI. Comparison of Technological Characteristics
The MectaFix CL Fixation Button with Continuous Loop implants and the predicate device share the following characteristics:
- shape: ●
- dimension;
- loop sizes; and ●
- button material of construction. ●
The MectaFix CL Fixation Button with Continuous Loop implants and the predicate devices are technologically different with respect to:
- . number of sutures; and
- suture materials. ●
Discussion
Based on the comparison of technological characteristics and performance data provided within this submission, the MectaFix CL Fixation Button with Continuous Loop implants are substantially equivalent to the identified predicate device.
VII. Performance Data
Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed on worst-case implants in support of a substantial equivalence determination:
Non-Clinical Studies:
- cvclic loading ●
- . tensile strength per ASTM D2256/D2256M-10
- Cadaver testing ●
- Sterilization validation
- Shelf-life testing
- Pyrogenicity .
5
- Bacterial Endotoxin Test (LAL test) was conducted according to European o Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination
- the subject devices are not labeled as non-pyrogenic or pyrogen free о
VIII. Conclusion
The information provided with this submission supports that the MectaFix CL Fixation Button with Continuous Loop implants are substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations.