(29 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI or ML.
No.
The device is an implant used in reconstructive surgery, which is a structural or mechanical function, not for treating or curing a disease or condition in a therapeutic sense.
No
The device is described as an adjustable loop solution for knee ligament reconstruction surgery, indicating it is an implant used for treatment, not diagnosis. Its purpose is to facilitate the surgical repair of knee ligaments, not to identify or characterize a medical condition.
No
The device description clearly outlines physical components made of metal and suture, intended for surgical implantation. It also details performance testing related to these physical components (biocompatibility, pyrogenicity, etc.), indicating it is a hardware device.
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 use during knee ligament reconstruction surgery. This is a surgical procedure performed on the patient's body.
- Device Description: The description details a physical implant (metal button, sutures, tape) used to secure a graft within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device is a surgical implant used to repair a physical structure within the body.
N/A
Intended Use / Indications for Use
FairFix QT Adjustable Button is intended to be used with single ended graft, during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized.
FairFix Extenders are intended to be used in association with FairFix QT Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø6 - 11 mm tunnel.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The FairFix QT Adjustable Button is a Medacta SportsMed device line extension providing a new adjustable loop solution meant for use with single-end graft during knee ligament reconstruction surgery (i.e. ACL, PCL).
The subject device consists of a metal elongated button with a pre-assembled, nonabsorbable adjustable suture loop, a graft tape 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 with two needled whipstitch sutures allowing implant graft connection and all the components are pre-assembled on a dedicated card, aiming to facilitate device handling.
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
- PERFORMANCE TESTING
- FairFix QT Adjustable Button and FairFix Adjustable Button Substantial Equivalence Assessment
- MR safety evaluation
- 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 evaluation
- SHELF-LIFE evaluation
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.
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.
Not Found
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
January 17, 2023
Image /page/0/Picture/1 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medacta International S.A. % Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K223795
Trade/Device Name: FairFix QT Adjustable Button Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 15, 2022 Received: December 19, 2022
Dear Christopher 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
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/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,
Sara S. Thompson -S
For
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
2
Indications for Use
510(k) Number (if known)
K223795
Device Name FairFix QT Adjustable Button
Indications for Use (Describe)
FairFix QT Adjustable Button is intended to be used with single ended graft, during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a 04.5 mm tunnel is realized.
FairFix Extenders are intended to be used in association with FairFix QT Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø6 - 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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3
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 Applicant Correspondent: Chris Lussier, Sr. Director, Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: December 15, 2022
II. Device
| Device Proprietary Name: | FairFix QT Adjustable Button |
|---|---|
| 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 primary predicate device:
- FairFix Adjustable Button System, K203259, Medacta International SA A
Device Description IV.
The FairFix QT Adjustable Button is a Medacta SportsMed device line extension providing a new adjustable loop solution meant for use with single-end graft during knee ligament reconstruction surgery (i.e. ACL, PCL).
The subject device consists of a metal elongated button with a pre-assembled, nonabsorbable adjustable suture loop, a graft tape 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 with two needled whipstitch sutures allowing implant graft connection and all the components are pre-assembled on a dedicated card, aiming to facilitate device handling.
4
V. Indications for Use
FairFix QT Adjustable Button is intended to be used with single ended graft, such as quad tendon graft, during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized.
FairFix Extenders are intended to be used in association with FairFix QT Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø6 - 11 mm tunnel.
Comparison of Technological Characteristics VI.
The subject device is substantially equivalent to the predicate device (K203259) with regards to the following characteristics:
- button shape and dimensions;
- adjustable loop shape and dimensions; ●
- pulling and flipping suture; ●
- materials:
- biocompatibility:
- device usage; ●
- sterilization method:
- shelf-life: and
- packaging. ●
The subject implant differs from the predicate device (K203259) only for the presence of the graft tape and whipstitch sutures.
Discussion
Medacta International SA has not made any change to the indications for use, general design and shape, materials, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.
Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the FairFix QT Adjustable Button to the identified predicate device.
Performance Data VII.
Based on the risk analysis, performance testing was conducted to written protocols. The following tests and rationales are provided in support of the substantial equivalence determination:
Non-Clinical Studies
- PERFORMANCE TESTING
- o FairFix QT Adjustable Button and FairFix Adjustable Button Substantial Equivalence Assessment
5
- 0 MR safety evaluation
- . PYROGENICITY
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is O equivalent to USP chapter )
- o Pyrogen test according to USP chapter for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY evaluation ●
- SHELF-LIFE evaluation
Clinical Studies:
- No clinical studies were conducted. ●
Conclusion VIII.
The information provided above supports that the FairFix QT Adjustable Button is substantially equivalent to the predicate device.