(59 days)
No
The summary describes a mechanical implant and instrument system for ankle replacement. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are focused on mechanical properties and wear analysis.
Yes
The device is an implant designed to replace the articulating surfaces of the ankle to reduce pain and restore motion, which are therapeutic effects for patients with ankle joint damage.
No
Explanation: The device is an implant and instrument system for total ankle replacement, designed to preserve motion in patients with ankle arthritis or who have had failed ankle surgery. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is an "implant and instrument system" consisting of physical components like a tibial implant, bearing implant, and talar implant. This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the restor3d Kinos Axiom Total Ankle System is an implant and instrument system designed to replace damaged ankle joints. It is a physical device implanted into the body.
- Intended Use: The intended use is to treat patients with ankle arthritis or failed ankle surgery by replacing the articulating surfaces of the ankle joint. This is a surgical intervention, not a diagnostic test.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting biomarkers or pathogens.
- Providing diagnostic information.
Therefore, the restor3d Kinos Axiom Total Ankle System is a medical device, specifically an implantable orthopedic device, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The restor3d Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The restor3d Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The restor3d Kinos Axiom Total Ankle System is intended for cement use only.
Product codes
HSN
Device Description
The subject restor3d Kinos Axiom Total Ankle System is an implant and instrument system designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion-extension movement within the ankle joint. The device is intended to be used with bone cement. The subject restor3d Kinos Axiom Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint.
The additively manufactured r3 talar dome and Vitamin E, cross-linked ultra-high molecular weight polyethylene (UHMWPE) r3 bearing component, subject of this 510(k), are compatible with:
- All Kinos Axiom Total Ankle System Tibial Tray Components and associated . instrumentation cleared via K192778
- All Kinos Axiom Total Ankle System X-Stem Tibial Components and associated . instrumentation cleared via K232595
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle joints
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)
The modified device was subjected to the following performance testing and/or analyses to establish substantial equivalence in comparison to the predicate devices.
- Contact Area Testing per ASTM F2665
- Constraint Testing per ASTM F2665
- Range of Motion Testing per ASTM F2665
- Locking Mechanism Fatigue Strength Analysis per ASTM F2665
- Implant Strength Engineering Analysis per ASTM F2665
- Wear Engineering Analysis per ASTM F2665
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K192778, K223316, K203447, K201393
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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April 29, 2024
restor3d, Inc. Anika Moorjani Regulatory Engineer 4001 E. NC 54 Highway Suite 3160 Durham, North Carolina 27709
Re: K240591
Trade/Device Name: restor3d Kinos Axiom Total Ankle System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN Dated: March 1, 2024 Received: March 1, 2024
Dear Anika Moorjani:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
| Peter G. | |
|---|---|
| Allen -S | |
| Digitally signed by Peter | |
| G. Allen -S | |
| Date: 2024.04.29 22:57:37 | |
| -04'00' |
For Lixin Liu. Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
restor3d Kinos Axiom Total Ankle System
Indications for Use (Describe)
The restor3d Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The restor3d Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The restor3d Kinos Axiom Total Ankle System is intended for cement use only.
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)
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510(k) Summary
Date Prepared: April 29, 2024
In accordance with 21 CFR 807.92 requirements, this information serves as a Summary of Substantial Equivalence for the restor3d Kinos Axiom Total Ankle System.
A. 510(k) Sponsor:
restor3d, inc. 4001 E. NC 54 Highway, Suite 3160 Durham, North Carolina, 27709
B. Primary Correspondent:
Anika Moorjani Regulatory Engineer (501) 240-3476 (direct) anika@restor3d.com
C. Premarket Notification:
| Trade Name: | restor3d Kinos Axiom Total Ankle System |
|---|---|
| Common Name: | Total Ankle Replacement |
| Classification Name: | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
| Regulation Number: | 21 CFR 888.3110 |
| Product Code: | HSN |
| Classification: | II |
| Review Panel: | Orthopedic |
D. Indications for Use:
The restor3d Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The restor3d Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The restor3d Kinos Axiom Total Ankle System is intended for cement use only.
4
E. Predicate Devices:
The subject line extension to the restor3d Kinos Axiom Total Ankle System is substantially equivalent to the following devices:
| 510(k) | Trade Name | Manufacturer |
|---|---|---|
| Primary Predicate Device | ||
| K123954 | INFINITY Total Ankle | |
| System | Wright Medical Technology, | |
| Inc. | ||
| Secondary Predicate Device | ||
| K182878 | SALTO TALARIS Total | |
| Ankle Prosthesis | Smith and Nephew, Inc. | |
| Reference Devices | ||
| K192778 | Kinos Axiom Total Ankle | |
| System | restor3d, Inc. | |
| Cleared under Kinos Medical | ||
| K223316 | Identity Imprint Porous | |
| Total Knee Replacement | ||
| System, Identity Imprint | ||
| Porous Cruciate Retaining | ||
| Total Knee Replacement | ||
| System | Conformis, Inc. | |
| Owned and operated by | ||
| restor3d, Inc. | ||
| K203447 | iTotal Identity Cruciate | |
| Retaining (CR) Total Knee | ||
| Replacement, iTotal | ||
| Identity Posterior | ||
| Stabilizing (PS) Total Knee | ||
| Replacement | Conformis, Inc. | |
| Owned and operated by | ||
| restor3d, Inc. | ||
| K201393 | Restor3d MTP Implant | restor3d, Inc. |
F. Device Description:
The subject restor3d Kinos Axiom Total Ankle System is an implant and instrument system designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion-extension movement within
5
the ankle joint. The device is intended to be used with bone cement. The subject restor3d Kinos Axiom Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint.
The additively manufactured r3 talar dome and Vitamin E, cross-linked ultra-high molecular weight polyethylene (UHMWPE) r3 bearing component, subject of this 510(k), are compatible with:
- All Kinos Axiom Total Ankle System Tibial Tray Components and associated . instrumentation cleared via K192778
- All Kinos Axiom Total Ankle System X-Stem Tibial Components and associated . instrumentation cleared via K232595
G. Performance Testing:
The modified device was subjected to the following performance testing and/or analyses to establish substantial equivalence in comparison to the predicate devices.
- Contact Area Testing per ASTM F2665 ●
- Constraint Testing per ASTM F2665 ●
- Range of Motion Testing per ASTM F2665 ●
- Locking Mechanism Fatigue Strength Analysis per ASTM F2665 .
- Implant Strength Engineering Analysis per ASTM F2665 ●
- Wear Engineering Analysis per ASTM F2665
H. Substantial Equivalence Comparison:
Substantial equivalence of the line extension to the predicate devices is based on the following:
- . The line extension for the r3 talar implant components and Vitamin E, cross-linked ultra-high molecular weight polyethylene (UHMWPE) bearing components have the same indications for use and intended use
- . The line extension for the r3 talar implant components and Vitamin E, cross-linked ultra-high molecular weight polyethylene (UHMWPE) bearing components share similar performance characteristics
- Changes in technological characteristics, including material and manufacturing . methods, are not shown to raise any different questions of safety or effectiveness
I. Conclusion:
6
Based on the comparison of the intended use and indications for use, the subject restor3d Kinos Axiom Total Ankle System is substantially equivalent to the predicate devices. The introduction of an additively manufactured cobalt-chromium talar component (per ASTM F3213), changes to introduce a vitamin E, cross-linked ultra-high molecular weight polyethylene (UHMWPE) bearing component, and changes to the design and size offerings do not raise issues of safety and effectiveness.