(56 days)
No
The document describes a mechanical knee implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes.
The device is indicated for use in knee arthroplasty to treat various degenerative joint diseases, correct functional deformity, and manage fractures, which are all therapeutic interventions aimed at restoring function and alleviating symptoms.
No
The device is a component of a total knee system, specifically cones used for revision procedures in knee arthroplasty, and it is implanted into the body. Its purpose is to treat conditions and deformities rather than diagnose them.
No
The device description clearly states that the device is a "one-piece device, conically shaped with cannulation all the way through the cone," indicating it is a physical implant component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description and Intended Use: The description clearly states that the Physica total knee system and the AMF Revision TT Cones are implants used in knee arthroplasty (joint replacement surgery). They are physically inserted into the patient's body to replace or augment damaged bone and joint structures.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient. The device's function is mechanical and structural within the body.
Therefore, this device falls under the category of a surgical implant rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Physica total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis;
- · Inflammatory degenerative joint disease including rheumatoid arthritis;
- · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed; and
- · Treatment of fractures that are unmanageable using other techniques.
In patients with preserved and well functioning collateral ligaments. Physica PS components are also for:
- · Absent or not-functioning posterior cruciate ligament;
- · Severe antero-posterior instability of the knee joint
AMF Revision 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 metaphysed fixation in the clinical judgment of the surgeon. Tibial and femoral cones are intended fixation to the bone and are fixed to the femoral and tibial implants using bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
Device Description
The AMF Revision TT Cones are intended to be used as an optional accessory component in Total Knee Arthroplasty in combinations with the Physica tibial plate (K141934, K151266 and K152008) and Physica PS femoral component (K152008). The AMF Revision TT Cones are one-piece devices, 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
Indicated Patient Age Range
skeletally mature patients
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)
Non-clinical testing: Fatigue resistance of the Physica System with AMF Revision TT Tibial Cones (Internal protocol derived from ASTM F1800).
Clinical testing: Clinical testing was not necessary to demonstrate substantial equivalence of the new AMF Revision TT Cones to the predicate devices.
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.
K053340, K102896, K103517, K143393
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
§ 888.3560 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
May 7, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
LimaCorporate S.p.A % Lacey Harbour Regulatory Manager Lima USA Inc 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006
Re: K200653
Trade/Device Name: AMF Revision 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: January 31, 2020 Received: March 12, 2020
Dear Lacey Harbour:
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
1
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 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 medical devices and radiation-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, Ph.D., R.A.C. Acting 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
2
Indications for Use
510(k) Number (if known) K200653
Device Name AMF Revision TT Cones
Indications for Use (Describe)
Physica total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis;
- · Inflammatory degenerative joint disease including rheumatoid arthritis;
- · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed; and
- · Treatment of fractures that are unmanageable using other techniques.
In patients with preserved and well functioning collateral ligaments. Physica PS components are also for:
- · Absent or not-functioning posterior cruciate ligament;
- · Severe antero-posterior instability of the knee joint
AMF Revision 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 metaphysed fixation in the clinical judgment of the surgeon. Tibial and femoral cones are intended 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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3
Summary of Safety and Effectiveness
Date: April 30, 2020
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Lacey Harbour, MB(ASCP)CM US Regulatory Manager Lacey.harbour@limacorporate.com Limacorporate S.p.A. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006 USA www.limacorporate.com
Office Phone: 817.385.0777 ext.200 Cell Phone: 432.638.6615 FAX: 817.385.0377
| Product | Common
Name | Product
Code | Regulation and Classification Name |
|--------------------------|----------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| AMF Revision
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 Revision TT Cones are intended to be used as an optional accessory component in Total Knee Arthroplasty in combinations with the Physica tibial plate (K141934, K151266 and K152008) and Physica PS femoral component (K152008). The AMF Revision TT Cones are one-piece devices, conically shaped with cannulation all the way through the cone.
Indications for use
Physica total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis; ●
- Correction of functional deformity; ●
- Revision procedures where other treatments or devices have failed; and ●
- Treatment of fractures that are unmanageable using other techniques.
Traditional 510(k) – AMF Revision TT Cones April 09, 2020
4
In patients with preserved and well functioning collateral ligaments, Physica PS components are also for:
- Absent or not-functioning posterior cruciate ligament: .
- Severe antero-posterior instability of the knee joint ●
AMF Revision 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
| Company | Device name | Cleared via |
|---|---|---|
| ZIMMER | Trabecular Metal Knee System | |
| Augments | K053340, K102896 and | |
| K103517 | ||
| STRYKER | Triathlon Tritanium Cone Augments | K143393. |
Summary of technology comparison
The intended use, principles of operation, design, materials, sterility and methods of fixation of AMF Revision TT Cones are substantially equivalent to the ones of the predicate devices. Design Control Activities have been successfully completed.
Non-clinical testing
The following test were performed on AMF Revision TT Cones:
- Fatigue resistance of the Physica System with AMF Revision TT Tibial Cones ● (Internal protocol derived from ASTM F1800).
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of the new AMF Revision TT Cones to the predicate devices.
Conclusion
Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the AMF Revision TT Cones are substantially equivalent to the predicate devices identified in this premarket notification.