(30 days)
No
The summary describes a mechanical implant component for knee surgery and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an accessory component for total knee arthroplasty, which aims to restore function and relieve pain, aligning with the definition of a therapeutic device.
No
The device is an accessory component for total knee arthroplasty, intended for fixation to bone, and does not claim to diagnose any condition.
No
The device description clearly states the AMF TT Cones are one-piece devices made from Ti6A14V alloy, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the AMF TT Cones are for use in skeletally mature patients with bone defects or poor bone quality, requiring supplemental metaphyseal fixation during total knee arthroplasty. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a one-piece component made from Ti6A14V alloy, intended to be used as an accessory in total knee arthroplasty. This is a physical implant used in surgery.
- 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. The AMF TT Cones do not perform any such testing.
The device is a surgical implant used in vivo (within the living body) during a knee replacement procedure, not a diagnostic test performed in vitro (outside the living body).
N/A
Intended Use / Indications for Use
AMF TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon. Tibial and femoral cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.
Product codes
JWH, MBH
Device Description
The AMF TT Cones are intended to be used as an optional accessory component in total knee arthroplasty. The AMF TT Cones are one-piece devices, made from Ti6A14V alloy, conically shaped with cannulation all the way through the cone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee Joint
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
surgeon
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
Non-clinical testing: The new compatibility introduced with this 510(k) does not introduce a worst case for mechanical testing. Test results of mechanical testing submitted in K200653 are applicable. Additional testing to demonstrate substantial equivalence to predicate devices is thus not required.
Clinical testing: Clinical testing was not necessary to demonstrate substantial equivalence of the new AMF TT Cones to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 18, 2024
LimaCorporate S.p.A % Newman Kenneth Senior Regulatory Affairs Specialist Lima USA Inc 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006
Re: K234011
Trade/Device Name: AMF TT Cones Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: December 19, 2023 Received: December 19, 2023
Dear Newman Kenneth:
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.
1
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" (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 QS 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).
2
Sincerely,
Lixin Liu -S
Lixin Liu, Ph.D. Assistant Director 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
Expiration
See PRA.
Submission Number (if known)
Device Name
AMF TT Cones
Indications for Use (Describe)
AMF TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon. Tibial and femoral cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.
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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K234011 Page 1 of 2
Summary of Safety and Effectiveness
Date: December 19, 2023
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy
U.S. Contact Person: Kenneth Newman Kenneth.Newman@limacorporate.com Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006, USA www.limacorporate.com Cell Phone: 682-597-3381
| Product | Common
Name | Product
Code | Regulation and Classification Name |
|-----------------|----------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| AMF TT
Cones | Total knee
system | JWH | Knee joint Patellofemorotibial
Polymer/Metal/Polymer Semi-
Constrained Cemented Prosthesis per 21
CFR 888.3560 |
| | | MBH | Knee joint Patellofemorotibial
metal/polymer porous-coated
uncemented prosthesis per 21 CFR
888.3565 |
Description
The AMF TT Cones are intended to be used as an optional accessory component in total knee arthroplasty. The AMF TT Cones are one-piece devices, made from Ti6A14V alloy, conically shaped with cannulation all the way through the cone.
With this 510(k) submission, the compatibility of the AMF Revision TT Cones (K200653) with the EMPOWR Revision Knee (K230169) manufactured by Encore Medical, L.P. is introduced.
Indications for use
AMF TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon. Tibial and femoral cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.
Predicate Devices
| Device name | Cleared via | Company |
|---|---|---|
| AMF Revision TT Cones | K200653 | LimaCorporate S.p.A. |
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Summary of technology comparison
The intended use, principles of operation, design, materials, sterility and methods of fixation of AMF TT Cones are substantially equivalent to the ones of the predicate device. Design Control Activities have been successfully completed.
Non-clinical testing
The new compatibility introduced with this 510(k) does not introduce a worst case for mechanical testing. Test results of mechanical testing submitted in K200653 are applicable. Additional testing to demonstrate substantial equivalence to predicate devices is thus not required.
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of the new AMF TT Cones to the predicate device.
Conclusion
Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the AMF TT Cones are substantially equivalent to the predicate device identified in this premarket notification.