Quantum® Total Ankle Prosthesis

K191380 · In2bones Sas · HSN · Jan 29, 2020 · Orthopedic

Device Facts

• Record ID: K191380
• Device Name: Quantum® Total Ankle Prosthesis
• Applicant: In2bones Sas
• Product Code: HSN · Orthopedic
• Decision Date: Jan 29, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quantum® total ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Note: In the United States, the ankle prosthesis is intended for cement use only.

Device Story

Fixed-bearing total ankle replacement system; consists of tibial implant, tibial inlay, and talar implant. Tibial and talar components secured to bone via cement; inlay rigidly fixed to tibial implant intra-operatively. Inlay acts as bearing surface against talar implant to enable joint movement. Used by orthopedic surgeons in clinical settings for primary or revision ankle arthroplasty. System includes trial and drill/cutting guide instrumentation to assist implantation. Device restores joint function in patients with severe arthritis.

Clinical Evidence

Bench testing only. Included range of motion study, contact pressure/constraint evaluation, component fatigue analysis, insert locking mechanism testing (per ASTM F2665), and wear evaluation (per ISO 22622). Pyrogen testing performed via LAL test per ANSI/AAMI ST72:2011.

Technological Characteristics

Fixed-bearing design. Tibial implant: Ti-6Al-4V ELI titanium alloy with porous titanium coating. Tibial inlay: Ultra-High-Molecular-Weight Polyethylene (UHMWPE). Talar implant: Co-28Cr-6Mo cobalt-chromium alloy with porous titanium coating. Cemented fixation. Testing performed per ASTM F2665 and ISO 22622.

Indications for Use

Indicated for primary or revision total ankle replacement in patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

Regulatory Classification

Identification

An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Salto Talaris (K090076 & K153452)
• Cadence / Integra Total Ankle Replacement System (K151459)
• Vantage (K152217)

Submission Summary (Full Text)

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January 29, 2020

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo 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.

In2Bones SAS % Christine Scifert Regulatory Affairs Director In2Bones USA 6000 Poplar Avenue, Suite 115 Memphis, Tennessee 38119

Re: K191380

Trade/Device Name: Ouantum® Total Ankle Prosthesis Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN Dated: December 27, 2019 Received: December 30, 2019

Dear Christine Scifert:

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

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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 (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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ting Song, PhD, RAC Assistant Director (Acting) DHT6A: Division of Joint Arthroplasty 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) K191380

Device Name Quantum® Total Ankle Prosthesis

Indications for Use (Describe)

The Quantum® total ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

Note: In the United States, the ankle prosthesis is intended for cement use only.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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K191380
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Image /page/3/Picture/1 description: The image shows the logo for IN2BONES. The logo is set on a gray oval shape. The text "IN2BONES" is in white, with the "2" in orange. There is a white swoosh on the left side of the logo.

## For In2Bones QUANTUM® Total Ankle Prosthesis

| Sponsor identification | In2Bones SAS<br>28 chemin du Petit Bois<br>69130 Ecully – France<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment registration number | 3010470577 |
| Date of preparation | December 23, 2019 |
| Contact person | Christine Scifert<br>In2BonesUSA<br>6000 Poplar Avenue, suite 115<br>Memphis, TN 38119<br>Cell: 901-831-8053<br>Email: [e-mail] |
| Proprietary Name | QUANTUM® Total Ankle Prosthesis |
| Common name | Total Ankle Prosthesis |
| Device classification regulation | 21 CFR 888.3110 - Ankle joint metal/polymer semi-constrained<br>cemented prosthesis.<br>Class II |
| Device Product Code and Panel | HSN<br>87 orthopedics |
| Device<br>Description | The QUANTUM® Total Ankle Prosthesis is a fixed-bearing total<br>ankle replacement device.<br>The prosthesis is composed of a tibial implant, a tibial inlay, and a<br>talar implant. Both the tibial implant and talar implant are secured to<br>patient anatomy via bone cement; the intermediate inlay is rigidly<br>fixed to the tibial implant intra-operatively. When all three<br>components are implanted, the intermediate inlay acts as a bearing<br>along the talar implant, enabling movements at the replaced joint.<br>Components are available in a variety of sizes and design<br>configurations to accommodate the various anatomical needs of a<br>patient's ankle joint, and intended for both primary and revision<br>applications.<br>QUANTUM® Total Ankle Prosthesis is accompanied by a complete<br>instrumentation set including trial and drill/cutting guide to assist<br>surgeons in implantation of the device. |
| Materials | The tibial implant is manufactured from titanium alloy (Ti-6Al-4V<br>ELI) with porous titanium coating on the bone-contacting surface.<br>The tibial inlay is made of Ultra-High-Molecular-Weight<br>Polyethylene. The highly polished talar implant is manufactured from<br>cobalt-chromium alloy (Co-28Cr-6Mo) with porous titanium coating<br>on the bone-contacting surface. |
| Indications for<br>use: | The QUANTUM® total ankle prosthesis is indicated as a total ankle<br>replacement in primary or revision surgery for patients with ankle<br>joints damaged by severe rheumatoid, post-traumatic, or<br>degenerative arthritis.<br>Note: In the United States, the ankle prosthesis is intended for cement<br>use only. |
| Predicate<br>Devices | Primary predicate:<br>- Salto Talaris (K090076 & K153452), Tornier |
| | Additional predicates:<br>- Cadence / Integra Total Ankle Replacement System (K151459),<br>Ascension Orthopedics (acquired by Integra LifeSciences)<br>- Vantage (K152217), Exactech |
| Comparison of<br>Indications and<br>Technological<br>characteristics<br>and Substantial<br>Equivalence<br>Summary: | The In2Bones QUANTUM® total ankle prosthesis is similar to the<br>predicate devices Salto Talaris (K090076 & K153452), Cadence /<br>Integra Total Ankle Replacement System (K151459) and Vantage<br>(K152217) in indications for use, intended use, design, size ranges,<br>principle of operation and materials. |

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| Summary<br>Performance<br>Data | Performance testing of the QUANTUM® total ankle prosthesis was<br>assessed through mechanical bench testing and Finite element<br>analysis. Assessment included:<br>- Range of Motion study<br>- Contact pressure and constraint evaluation<br>- Component Fatigue analysis<br>- Insert Locking mechanism<br>These tests were performed according to ASTM F2665.<br>- Wear evaluation according to ISO22622<br>The results indicate that the QUANTUM® total ankle prosthesis met<br>the acceptance criteria. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pyrogen testing | The method used to make the determination that the device meets<br>pyrogen limit specification is the Limulus Amebocyte Lysate (LAL)<br>test in accordance with ANSI/AAMI ST72:2011: Bacterial<br>endotoxins – Test methods, routine monitoring and alternative to<br>batch testing. |
| CONCLUSION | Based on the comparison of indications for use and technological<br>characteristics and the results of the testing performed, the<br>QUANTUM® total ankle prosthesis is substantially equivalent to<br>the predicate devices identified in the 510(k) submission. |