(26 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility of surgical fixation devices, with no mention of AI/ML algorithms or data processing.
Yes
The device is intended for "Reconstructive treatment of ruptured anterior and posterior cruciate ligaments" which is a therapeutic intervention to repair damaged tissue.
No
Explanation: The device description and intended use clearly state that these devices are implantable fixation devices used during knee ligament reconstruction surgery for the fixation of the graft. There is no mention of diagnostics, and the system is not designed to identify, assess, or monitor medical conditions or diseases.
No
The device description explicitly states it includes "implantable fixation devices" which are physical hardware components. The performance studies also detail testing on these physical components (mechanical behavior, MR safety, biocompatibility, etc.).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are used during knee ligament reconstruction surgery for the fixation of the graft. This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details implantable fixation devices used to secure a graft during surgery. This aligns with a surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical behavior, cadaver lab testing, pyrogenicity, biocompatibility, and shelf-life – all relevant to a surgical implant, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
FairFix Adjustable Buttons are intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized.
FairFix Extender is intended to be used in association with any FairFix Adjustable Button configuration during a knee ligament (i.e. anterior cruciate ligament) reconstruction surgery with a Ø 6 - 11 mm tunnel.
Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.
Product codes
MBI
Device Description
The subject FairFix Adjustable Button System Extension is a Medacta SportsMed devices line extension providing two new implantable fixation devices with an adjustable suture loop used during knee ligament reconstruction surgery for the fixation of the graft by means of an extra cortical suspensory fixation.
Specifically, the current submission includes:
- FairFix AM Adjustable Button, a metal button with a pre-assembled, nonabsorbable . 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; and
- FairFix PSP Adjustable Button, an extra-cortical fixation device pre-assembled with a non-. absorbable adjustable suture loop indicated for the extracortical fixation of the graft on the tibial side.
Both the devices are provided pre-assembled on a dedicated card, aiming to facilitate device handling and connection to the graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee ligament (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 Design Validation, Cadaver Lab
- FairFix AM Adjustable Button Mechanical Behavior Validation Rationale
- FairFix PSP Adjustable Button Mechanical Behavior Validation Rationale
- MR safety evaluations
- 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)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo is composed of the letters 'FDA' in a bold, sans-serif font, with the words 'U.S. FOOD & DRUG' above it and 'ADMINISTRATION' below it. The text is in a blue color.
June 13, 2022
Medacta International S.A. % Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K221389
Trade/Device Name: FairFix AM Adjustable Button FairFix PSP Adjustable Button Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI
Dear Christopher Lussier:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 8, 2022. Specifically, FDA is updating this SE Letter due to a typographical error in the trade name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Laura C. Rose, Ph.D., OHT6: Office of Orthopedic Devices, by phone (301) 348-1947 or email at Laura.Rose@fda.hhs.gov.
Sincerely,
Melissa A. Ramcharan -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
1
June 8, 2022
Image /page/1/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
Medacta International S.A. % Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K221389
Trade/Device Name: FairFix AM - Adjustable Button FairFax PSP - 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: Mav 12, 2022 Received: May 13, 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
2
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,
Melissa A. Ramcharan -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
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Indications for Use
510(k) Number (if known) K221389
Device Name FairFix AM - Adjustable Button
Indications for Use (Describe)
FairFix Adjustable Buttons are intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized.
FairFix Extender is intended to be used in association with any FairFix Adjustable Button configuration during a knee ligament (i.e. anterior 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
510(k) Number (if known)
Device Name FairFix PSP – Adjustable Button
Indications for Use (Describe)
Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
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, Medacta USA Date Prepared: May 12, 2022 Date Revised: June 7, 2022
II. Device
| Device Proprietary Name: | FairFix AM - Adjustable Button |
|---|---|
| FairFix PSP - 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 devices:
Primary predicate device:
-
FairFix Adjustable Button System, K203259, Medacta International SA
Additional predicate device: -
M-ARS ACL, K171640, Medacta International SA
IV. Device Description
The subject FairFix Adjustable Button System Extension is a Medacta SportsMed devices line extension providing two new implantable fixation devices with an adjustable suture loop used during knee ligament reconstruction surgery for the fixation of the graft by means of an extra cortical suspensory fixation.
6
Specifically, the current submission includes:
- FairFix AM Adjustable Button, a metal button with a pre-assembled, nonabsorbable . 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; and
- FairFix PSP Adjustable Button, an extra-cortical fixation device pre-assembled with a non-. absorbable adjustable suture loop indicated for the extracortical fixation of the graft on the tibial side.
Both the devices are provided pre-assembled on a dedicated card, aiming to facilitate device handling and connection to the graft.
V. Indications for Use
. FairFix AM - Adjustable Button
FairFix Adjustable Buttons are intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized.
FairFix Extender is intended to be used in association with any FairFix Adjustable Button configuration during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø 6 - 11 mm tunnel.
FairFix PSP – Adiustable Button ●
Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.
VI. Comparison of Technological Characteristics
The subject devices are substantially equivalent to the predicate (K203259 for the FairFix AM and K171640 for the FairFix PSP) with regards to the following characteristics:
- indications for use; ●
- buttons shapes and dimensions; ●
- adjustable loop dimension; ●
- pulling and flipping suture of the FairFix AM; ●
- materials;
- biocompatibility:
- device usage;
- shelf-life; and ●
- packaging. ●
The subject implants differ from the predicate devices (K203259 for the FairFix AM and K171640 for the FairFix PSP) as follows:
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- o adjustable loop - shape and mechanism; and
- sterilization method of the FairFix PSP Adjustable Button with respect to M-ARS ACL o Pull Suture Plate (K171640).
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 Adjustable Button System Extension implants to the identified predicate devices.
VII. Performance Data
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 ●
- FairFix Design Validation, Cadaver Lab o
- FairFix AM Adjustable Button Mechanical Behavior Validation Rationale O
- FairFix PSP Adjustable Button Mechanical Behavior Validation Rationale O
- MR safety evaluations O
- PYROGENICITY ●
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 o (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination O
- The subject devices are not labeled as non-pyrogenic or pyrogen free. O
- BIOCOMPATIBILITY evaluation ●
- SHELF-LIFE evaluation ●
Clinical Studies:
- No clinical studies were conducted. ●
VIII. Conclusion
The information provided above supports that the FairFix Adjustable Button System Extension implants are substantially equivalent to the predicate devices.