(141 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility of a surgical implant, with no mention of AI/ML capabilities or data processing.
Yes.
The device is used during knee ligament reconstruction surgery for fixation of tendons and ligaments, which directly treats a medical condition.
No
The provided text describes a medical device, the FairFix Adjustable Button System, intended for use during knee ligament reconstruction surgery for fixation of tendons and ligaments. Its purpose is to provide mechanical support, not to diagnose a condition.
No
The device description explicitly details physical, implantable components made of metal and suture, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for use during knee ligament reconstruction surgery for the fixation of tendons and ligaments. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implantable system consisting of a metal button, suture loops, and an extender. These are physical components used to mechanically fix tissues within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality. This device does not perform any such tests on biological samples.
The device is clearly a surgical implant used for mechanical fixation during a reconstructive procedure.
N/A
Intended Use / Indications for Use
FairFix Adjustable Button is intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5mm tunnel is realized.
FairFix Extender is intended to be used in association with FairFix Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø 6 – 11 mm tunnel.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The FairFix Adjustable Button System includes implantable devices indicated for knee ligament (i.e. ACL, PCL) reconstructive surgery for the fixation of tendons and ligaments by means of a suspensory fixation with an adjustable suture loop.
The FairFix Adjustable Button consists of a metal button with a pre-assembled, non-absorbable adjustable suture loop to be coupled with the graft, a pulling suture (blue) to pull the construct through the bone tunnel and a flipping suture (white) to flip the button once the extracortical side has been reached.
The device is provided pre-assembled on a dedicated graft preparation card, aiming to facilitate implant-graft connection.
The FairFix Adjustable Button Extender is intended to be used in association with the FairFix Adjustable Button in case of large tunnel conditions (e.g. cortical blowout, revision cases, full tunnel). It consists of an elongated metal plate with a recess to house the FairFix Adjustable Button and a lateral slot to allow suture passage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee ligament (i.e. anterior cruciate ligament and posterior 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
- DESIGN VALIDATION
- FairFix Adjustable Button System Design Validation
- FairFix Adjustable Button Protective Card Design Validation
- CHARACTERIZATION TESTING
- Extracortical fixation devices: Lengthening under Cyclic Loading and Load to Failure
- FairFix Adjustable Button System MR Safety Evaluation and Testing
- PYROGENICITY:
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination
- The subject devices are not labeled as non-pyrogenic or pyrogen free
- BIOCOMPATIBILITY:
- Biocompatibility assessment as per ISO 10993 series and FDA Biocompatibility Guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"
- DESIGN VALIDATION
- Clinical Studies:
- No clinical studies were conducted.
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.
ACL TightRope, K112990, GraftMax Cradle, K151037
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.
OrthoButton AL, K171060, M-ARS ACL, K171640
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.
0
March 26, 2021
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Medacta International SA % Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K203259/S001
Trade/Device Name: FairFix Adjustable Button System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 22, 2021 Received: February 26, 2021
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 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
1
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.
Laura C. Rose, Ph.D. 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) K203259
Device Name FairFix Adjustable Button System
Indications for Use (Describe)
FairFix Adjustable Button is intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5mm tunnel is realized.
FairFix Extender is intended to be used in association with FairFix Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø 6 - 11 mm tunnel.
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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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 Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: November 4, 2020 Date Revised: March 26, 2021
II. Device
| Device Proprietary Name: | FairFix Adjustable Button System |
|---|---|
| Common or Usual Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Primary Product Code: | MBI |
| Regulation Number: | 21 CFR 888.3040 |
| Device Classification: | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary Predicate:
-
ACL TightRope, K112990, Arthrex Inc.
Secondary Predicate: -
GraftMax Cradle, K151037, Conmed Corporation
In addition, the following reference devices are cited within the submission: -
OrthoButton AL, K171060, Riverpoint Medical
-
M-ARS ACL, K171640, Medacta International SA
IV. Device Description
The FairFix Adjustable Button System includes implantable devices indicated for knee ligament (i.e. ACL, PCL) reconstructive surgery for the fixation of tendons and ligaments by means of a suspensory fixation with an adjustable suture loop.
The FairFix Adjustable Button consists of a metal button with a pre-assembled, non-absorbable adjustable suture loop to be coupled with the graft, a pulling suture (blue) to pull the construct through
4
the bone tunnel and a flipping suture (white) to flip the button once the extracortical side has been reached.
The device is provided pre-assembled on a dedicated graft preparation card, aiming to facilitate implant-graft connection.
The FairFix Adjustable Button Extender is intended to be used in association with the FairFix Adjustable Button in case of large tunnel conditions (e.g. cortical blowout, revision cases, full tunnel). It consists of an elongated metal plate with a recess to house the FairFix Adjustable Button and a lateral slot to allow suture passage.
V. Indications for Use
FairFix Adjustable Button is intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5mm tunnel is realized.
FairFix Extender is intended to be used in association with FairFix Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø 6 – 11 mm tunnel.
Comparison of Technological Characteristics VI.
FairFix Adiustable Button o
The subject FairFix Adjustable Button and the predicate, ACL TightRope (K112990), share the following characteristics:
- pulling suture dimension; ●
- materials:
- biocompatibility:
- device usage: ●
- sterility; and ●
- packaging.
The subject FairFix Adjustable Button and the predicate, ACL TightRope (K112990), differ with regards to the following characteristics:
- o button shape and dimension;
- adjustable loop dimension and shape/mechanism; and ●
- flipping suture.
- · FairFix Adjustable Button Extender
The subject FairFix Adjustable Button Extender and the predicate, GraftMax Cradle (K151037), share the following characteristics:
- shape and dimension; ●
- biocompatibility:
- device usage; and ●
- o packaging.
5
The subject FairFix Adjustable Button Extender and the predicate, GraftMax Cradle (K151037), only differ with regards to the sterilization method.
Discussion
Medacta International SA has not made any change to the intended use, device usage, materials, biocompatibility, sterility and packaging of the subject FairFix Adjustable Button System.
The comparison of technological characteristics and performance data provided within this submission, shows that there are no new risks associated with the subject FairFix Adjustable Button System design, and supports the substantial equivalence of the FairFix Adjustable Button System to the identified predicate devices.
VII. Performance Data
Based on the risk analysis, design validation and characterization testing were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- DESIGN VALIDATION
- 0 FairFix Adjustable Button System Design Validation
- o FairFix Adjustable Button Protective Card Design Validation
- CHARACTERIZATION TESTING ●
- Extracortical fixation devices: Lengthening under Cyclic Loading and Load to Failure о
- FairFix Adjustable Button System MR Safety Evaluation and Testing о
- PYROGENICITY: ●
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- 0 Pyrogen test according to USP chapter for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free
- BIOCOMPATIBILITY: ●
- o Biocompatibility assessment as per ISO 10993 series and FDA Biocompatibility Guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"
Clinical Studies:
- No clinical studies were conducted. ●
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VIII. Conclusion
The information provided above supports that the FairFix Adjustable Button System is substantially equivalent to the predicate devices. Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations.