(251 days)
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.
The QUANTUM® Total Ankle Prosthesis is a fixed-bearing total ankle replacement device. The prosthesis is composed of a tibial implant, a tibial inlay, and a talar implant. Both the tibial implant and talar implant are secured to patient anatomy via bone cement; the intermediate inlay is rigidly fixed to the tibial implant intra-operatively. When all three components are implanted, the intermediate inlay acts as a bearing along the talar implant, enabling movements at the replaced joint. Components are available in a variety of sizes and design configurations to accommodate the various anatomical needs of a patient's ankle joint, and intended for both primary and revision applications. QUANTUM® Total Ankle Prosthesis is accompanied by a complete instrumentation set including trial and drill/cutting guide to assist surgeons in implantation of the device.
The In2Bones QUANTUM® Total Ankle Prosthesis underwent performance testing to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method (Reference Standard) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Bench Testing (ASTM F2665) | The specific quantitative acceptance criteria are not detailed in the provided text, but generally, for total ankle prostheses tested to ASTM F2665, criteria would involve demonstrating sufficient: - Range of Motion: Allowable physiological range of motion without impingement or abnormal articulation. - Contact Pressure and Constraint: Acceptable contact stress distributions on articulating surfaces and adequate constraint against abnormal translations/rotations. - Component Fatigue: Resistance to fracture or failure under cyclic loading representative of physiological conditions for a specified number of cycles. - Insert Locking Mechanism: Secure engagement and retention of the insert within the tibial component under relevant forces. | The results indicate that the QUANTUM® total ankle prosthesis met the acceptance criteria for: - Range of Motion study - Contact pressure and constraint evaluation - Component Fatigue analysis - Insert Locking mechanism |
| Wear Evaluation (ISO 22622) | The specific quantitative acceptance criteria for wear are not detailed in the provided text, but generally, for total ankle prostheses tested to ISO 22622, criteria would involve demonstrating that the wear rate of the articulating components (specifically the polyethylene insert) is within acceptable limits to ensure long-term device function and minimize wear debris generation. | The results indicate that the QUANTUM® total ankle prosthesis met the acceptance criteria for wear evaluation. |
| Pyrogen Testing (ANSI/AAMI ST72:2011) | The device must meet the pyrogen limit specification according to ANSI/AAMI ST72:2011. This typically involves demonstrating that the endotoxin level is below a specified threshold. | The device meets pyrogen limit specification as determined by the Limulus Amebocyte Lysate (LAL) test. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not specify the sample sizes used for the mechanical bench testing, wear evaluation, or pyrogen testing. It also does not mention the data provenance (e.g., country of origin, retrospective/prospective) for these tests, as these are in vitro and in silico studies, not human subject data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The performance data for this medical device (a total ankle prosthesis) is based on mechanical bench testing, finite element analysis, and laboratory pyrogen testing, not on human expert interpretation of images or clinical data. Therefore, there is no "ground truth" established by experts in the context of a test set, nor are there experts "qualifications" relevant to this type of testing.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the testing performed is mechanical and laboratory-based, not involving human interpretation or adjudication processes typical of clinical studies or image-based AI evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. The provided information pertains to the mechanical and biological safety performance of the device itself, not to a diagnostic or interpretive AI system that would assist human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is not an AI algorithm but a physical medical device. The "performance" described is the standalone performance of the implant under various simulated physiological conditions.
7. The Type of Ground Truth Used:
The "ground truth" for the performance testing is based on:
- Engineering principles and material science standards: For mechanical bench testing (ASTM F2665), wear evaluation (ISO 22622), and finite element analysis, the "ground truth" is adherence to established industry-recognized performance metrics and models that predict in-vivo behavior.
- Biological safety standards: For pyrogen testing (ANSI/AAMI ST72:2011), the "ground truth" is the absence of pyrogens above a defined safe limit.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no AI training set for this device.
{0}------------------------------------------------
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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) | |
|---|---|
| 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."
{3}------------------------------------------------
K191380
Page 1 of 3
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 SAS28 chemin du Petit Bois69130 Ecully – FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29 |
|---|---|
| Establishment registration number | 3010470577 |
| Date of preparation | December 23, 2019 |
| Contact person | Christine ScifertIn2BonesUSA6000 Poplar Avenue, suite 115Memphis, TN 38119Cell: 901-831-8053Email: christine.scifert@i2b-usa.com |
| Proprietary Name | QUANTUM® Total Ankle Prosthesis |
| Common name | Total Ankle Prosthesis |
| Device classification regulation | 21 CFR 888.3110 - Ankle joint metal/polymer semi-constrainedcemented prosthesis.Class II |
| Device Product Code and Panel | HSN87 orthopedics |
| DeviceDescription | The QUANTUM® Total Ankle Prosthesis is a fixed-bearing totalankle replacement device.The prosthesis is composed of a tibial implant, a tibial inlay, and atalar implant. Both the tibial implant and talar implant are secured topatient anatomy via bone cement; the intermediate inlay is rigidlyfixed to the tibial implant intra-operatively. When all threecomponents are implanted, the intermediate inlay acts as a bearingalong the talar implant, enabling movements at the replaced joint.Components are available in a variety of sizes and designconfigurations to accommodate the various anatomical needs of apatient's ankle joint, and intended for both primary and revisionapplications.QUANTUM® Total Ankle Prosthesis is accompanied by a completeinstrumentation set including trial and drill/cutting guide to assistsurgeons in implantation of the device. |
| Materials | The tibial implant is manufactured from titanium alloy (Ti-6Al-4VELI) with porous titanium coating on the bone-contacting surface.The tibial inlay is made of Ultra-High-Molecular-WeightPolyethylene. The highly polished talar implant is manufactured fromcobalt-chromium alloy (Co-28Cr-6Mo) with porous titanium coatingon the bone-contacting surface. |
| Indications foruse: | The QUANTUM® total ankle prosthesis is indicated as a total anklereplacement in primary or revision surgery for patients with anklejoints damaged by severe rheumatoid, post-traumatic, ordegenerative arthritis.Note: In the United States, the ankle prosthesis is intended for cementuse only. |
| PredicateDevices | Primary predicate:- Salto Talaris (K090076 & K153452), Tornier |
| Additional predicates:- Cadence / Integra Total Ankle Replacement System (K151459),Ascension Orthopedics (acquired by Integra LifeSciences)- Vantage (K152217), Exactech | |
| Comparison ofIndications andTechnologicalcharacteristicsand SubstantialEquivalenceSummary: | The In2Bones QUANTUM® total ankle prosthesis is similar to thepredicate devices Salto Talaris (K090076 & K153452), Cadence /Integra Total Ankle Replacement System (K151459) and Vantage(K152217) in indications for use, intended use, design, size ranges,principle of operation and materials. |
{4}------------------------------------------------
{5}------------------------------------------------
| SummaryPerformanceData | Performance testing of the QUANTUM® total ankle prosthesis wasassessed through mechanical bench testing and Finite elementanalysis. Assessment included:- Range of Motion study- Contact pressure and constraint evaluation- Component Fatigue analysis- Insert Locking mechanismThese tests were performed according to ASTM F2665.- Wear evaluation according to ISO22622The results indicate that the QUANTUM® total ankle prosthesis metthe acceptance criteria. |
|---|---|
| Pyrogen testing | The method used to make the determination that the device meetspyrogen limit specification is the Limulus Amebocyte Lysate (LAL)test in accordance with ANSI/AAMI ST72:2011: Bacterialendotoxins – Test methods, routine monitoring and alternative tobatch testing. |
| CONCLUSION | Based on the comparison of indications for use and technologicalcharacteristics and the results of the testing performed, theQUANTUM® total ankle prosthesis is substantially equivalent tothe predicate devices identified in the 510(k) submission. |
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.