(251 days)
Not Found
No
The description focuses on the mechanical components and surgical instrumentation of a total ankle replacement prosthesis, with no mention of AI or ML capabilities.
Yes
The device is a total ankle prosthesis indicated for total ankle replacement in patients with ankle joints damaged by severe arthritis, which is a therapeutic intervention.
No
The device description clearly states it is a "fixed-bearing total ankle replacement device" that is implanted to enable movement at a replaced joint. This indicates a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states it is a physical prosthesis composed of a tibial implant, tibial inlay, and talar implant, and is accompanied by a complete instrumentation set.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "total ankle replacement" for patients with damaged ankle joints. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical prosthesis composed of implants and an inlay, designed to be surgically implanted into the ankle joint. This is consistent with a medical device for structural replacement, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
Therefore, the Quantum® total ankle prosthesis is a medical device, specifically a surgical implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HSN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle joint
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)
Performance testing of the QUANTUM® total ankle prosthesis was assessed through mechanical bench testing and Finite element analysis. Assessment included:
- Range of Motion study
- Contact pressure and constraint evaluation
- Component Fatigue analysis
- Insert Locking mechanism
These tests were performed according to ASTM F2665. - Wear evaluation according to ISO22622
The results indicate that the QUANTUM® total ankle prosthesis met the acceptance criteria.
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.
K090076, K153452, K151459, K152217
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
§ 888.3110 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.
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 SAS
28 chemin du Petit Bois
69130 Ecully – France
Phone: +33.4.72.29.26.26
Fax: +33.4.72.29.26.29 |
|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment registration number | 3010470577 |
| Date of preparation | December 23, 2019 |
| Contact person | Christine Scifert
In2BonesUSA
6000 Poplar Avenue, suite 115
Memphis, TN 38119
Cell: 901-831-8053
Email: 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-constrained
cemented prosthesis.
Class II |
| Device Product Code and Panel | HSN
87 orthopedics |
| Device
Description | 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. |
| Materials | The tibial implant is manufactured from titanium alloy (Ti-6Al-4V
ELI) with porous titanium coating on the bone-contacting surface.
The tibial inlay is made of Ultra-High-Molecular-Weight
Polyethylene. The highly polished talar implant is manufactured from
cobalt-chromium alloy (Co-28Cr-6Mo) with porous titanium coating
on the bone-contacting surface. |
| Indications for
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. |
| Predicate
Devices | 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 of
Indications and
Technological
characteristics
and Substantial
Equivalence
Summary: | The In2Bones QUANTUM® total ankle prosthesis is similar to the
predicate 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
| Summary
Performance
Data | Performance testing of the QUANTUM® total ankle prosthesis was
assessed through mechanical bench testing and Finite element
analysis. Assessment included:
- Range of Motion study
- Contact pressure and constraint evaluation
- Component Fatigue analysis
- Insert Locking mechanism
These tests were performed according to ASTM F2665. - Wear evaluation according to ISO22622
The results indicate that the QUANTUM® total ankle prosthesis met
the acceptance criteria. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pyrogen testing | The method used to make the determination that the device meets
pyrogen limit specification is the Limulus Amebocyte Lysate (LAL)
test in accordance with ANSI/AAMI ST72:2011: Bacterial
endotoxins – Test methods, routine monitoring and alternative to
batch testing. |
| CONCLUSION | Based on the comparison of indications for use and technological
characteristics and the results of the testing performed, the
QUANTUM® total ankle prosthesis is substantially equivalent to
the predicate devices identified in the 510(k) submission. |