FairFix Adjustable Button System

K203259 · Medacta International S.A. · MBI · Mar 26, 2021 · Orthopedic

Device Facts

• Record ID: K203259
• Device Name: FairFix Adjustable Button System
• Applicant: Medacta International S.A.
• Product Code: MBI · Orthopedic
• Decision Date: Mar 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

FairFix Adjustable Button System provides suspensory fixation for tendons/ligaments during knee reconstruction; consists of metal button with pre-assembled non-absorbable adjustable suture loop, pulling suture, and flipping suture; provided on graft preparation card. FairFix Extender (elongated metal plate) used for large tunnels (6-11mm) to house button. Used in OR by orthopedic surgeons. Device facilitates graft-implant connection; surgeon pulls construct through bone tunnel and flips button extracortically. System provides mechanical fixation of graft to bone; benefits patient by securing ligament reconstruction.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence supported by bench testing, including design validation, cyclic loading, load to failure, MR safety evaluation, pyrogenicity testing (LAL/USP <151>), and biocompatibility assessment per ISO 10993.

Technological Characteristics

Metallic bone fixation fastener; adjustable suture loop mechanism; includes metal button and extender plate. Biocompatibility per ISO 10993. Pyrogenicity testing per European Pharmacopoeia §2.6.14/USP <85> and USP <151>. Mechanical testing includes cyclic loading and load to failure. MR safety evaluated.

Indications for Use

Indicated for patients undergoing knee ligament (ACL/PCL) reconstruction surgery requiring graft fixation via suspensory adjustable suture loop.

Regulatory Classification

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.

Predicate Devices

• ACL TightRope (K112990)
• GraftMax Cradle (K151037)

Reference Devices

• OrthoButton AL (K171060)
• M-ARS ACL (K171640)

Submission Summary (Full Text)

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March 26, 2021

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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

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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 ([e-mail]) or phone [phone] 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)

| <span></span> | <span></span> |
|----------------------------------------------------------|---------------------------------------------------------|
| <div></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> 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 [phone] Fax [phone]

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

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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.

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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 <85>)
- 0 Pyrogen test according to USP chapter <151> 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.