(40 days)
No
The document describes a total knee replacement system and its components. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The focus is on the mechanical properties and materials of the implants.
Yes
The Physica system is a total knee replacement system that treats conditions like osteoarthritis, rheumatoid arthritis, and functional deformities, which is a therapeutic purpose.
No
The device described is a total knee replacement system, which is a medical implant used for treatment of knee conditions, not for diagnosis.
No
The device description clearly states that the Physica system is a total knee replacement system consisting of physical components like a Femoral component, Tibial plate, Tibial liner, Tibial stem, and Patella component. 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:
- Intended Use: The intended use clearly describes a surgical implant for replacing parts of the knee joint in patients with various conditions. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a total knee replacement system consisting of physical components (Femoral component, Tibial plate, etc.) that are implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information about a patient's health status.
Therefore, the Physica system is a medical device (specifically, a surgical implant), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease including
- o osteoarthritis
- traumatic arthritis, and o
- avascular necrosis (not applicable to Physica TT Tibial Plate); o
- · 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.
Additional indications for Physica LMC component are:
-
. Moderate varus, valgus, or flexion deformities.
In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated 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 surgeon.
Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the fixed to the femoral and tibial implants using bone cement. Tibial liners can be used with cemented or uncemented tibial or femoral components.
Product codes
MBH, JWH, HRY
Device Description
The Physica system is a total knee replacement system consisting of a Femoral component, a Tibial plate, a Tibial liner, a Tibial stem and a Patella component; the Tibial stem and the Patella component are optional to be used as required for each individual patient and as allowed in the Instructions for Use.
The Physica Porous Femoral components are made of CoCrMo alloy and the internal surface is PoroTi coated; they are intended to be used without bone cement; the components to be used in combination with (Tibial plate, TT Tibial plate, Tibial liner, Tibial stem, Patella) were previously cleared (K141934, K152008, K190911, K201084).
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
Prescription Use
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: Mechanical safety of the subject cementless Physica Porous Femoral components were confirmed through a comparison with previously cleared (K141934, K152008, K190911, K201084) cemented Physica Femoral components. The analyses (e.g. drawings overlap and testing provided) demonstrated that device performance fulfill the intended use and are substantially equivalent to the predicate devices. The PoroTi coating of subject Porous Femoral components fulfills the conformity to the FDA guidelines and referenced standards and the analysis was performed on worst case components or constructs.
Clinical testing: Clinical testing was not necessary to demonstrate substantial equivalence of the new Physica Porous Femoral components to the predicate devices.
Key Results: Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the Physica systems (including subject Physica Porous Femoral components) are substantially equivalent to the predicate devices identified in this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K141934, K152008, K190911, K033489, K050222, K060303, K113550
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
April 6, 2021
Image /page/0/Picture/1 description: The image shows 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 includes 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 Official Correspondent Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006
Re: K210554
Trade/Device Name: Physica system Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH, HRY Dated: January 15, 2021 Received: February 25, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (0S) 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 So
Ting Song, Ph.D., R.A.C. 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
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K210554
Device Name Physica system
Indications for Use (Describe)
Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease including
- o osteoarthritis
- traumatic arthritis, and o
- avascular necrosis (not applicable to Physica TT Tibial Plate); o
- · 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.
Additional indications for Physica LMC component are:
-
. Moderate varus, valgus, or flexion deformities.
In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated 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 surgeon.
Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the fixed to the femoral and tibial implants using bone cement. Tibial liners can be used with cemented or uncemented tibial or femoral components.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
Summary of Safety and Effectiveness
Date: January 15th, 2021
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Dr. Lacey Harbour lacey.harbour@limacorporate.com Lima USA Inc. 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
Trade name: Physica system Common Name: Knee prosthesis
Classification Name:
| Product Code | Regulation and Classification Name |
|---|---|
| MBH | Knee joint patellofemorotibial metal/polymer porous-coated |
| uncemented prosthesis per 21 CFR 888.3565 | |
| JWH | Knee joint Patellofemorotibial Polymer/Metal/Polymer Semi- |
| Constrained Cemented Prosthesis per 21 CFR 888.3560 | |
| HRY | Knee joint Femorotibial Metal/Polymer Semi-Constrained Cemented |
| Prosthesis per 21 CFR 888.3530 |
Description:
The Physica system is a total knee replacement system consisting of a Femoral component, a Tibial plate, a Tibial liner, a Tibial stem and a Patella component; the Tibial stem and the Patella component are optional to be used as required for each individual patient and as allowed in the Instructions for Use.
The Physica Porous Femoral components are made of CoCrMo alloy and the internal surface is PoroTi coated; they are intended to be used without bone cement; the components to be used in combination with (Tibial plate, TT Tibial plate, Tibial liner, Tibial stem, Patella) were previously cleared (K141934, K152008, K190911, K201084).
Indications for Use:
Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
· Non-inflammatory degenerative joint disease including
- osteoarthritis O
- traumatic arthritis, and O
- avascular necrosis (not applicable to Physica TT Tibial Plate); O
- · Inflammatory degenerative joint disease including rheumatoid arthritis;
- · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed; and
5
· Treatment of fractures that are unmanageable using other techniques.
Additional indications for Physica LMC component are:
- · Moderate varus, valgus, or flexion deformities.
In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated 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.
Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.
Tibial liners can be used with cemented or uncemented tibial or femoral components.
| No. | Company | Device name | Cleared via |
|---|---|---|---|
| 1 | |||
| (primary | |||
| predicate) | LIMACORPORATE | Physica | |
| system | Main reference: K201084 | ||
| Other references: K141934, | |||
| K152008, K190911 | |||
| 2 | ZIMMERBIOMET | Vanguard | |
| Knee System | K033489, K050222, K060303, | ||
| K113550 |
Predicate Devices:
Summary of technology comparison:
The intended use, design, and materials of the subject Physica Porous Femoral components (part of Physica system) are substantially equivalent to those of the predicate devices. Design Control Activities have been successfully completed.
Non-clinical testing
Mechanical safety of the subject cementless Physica Porous Femoral components were confirmed through a comparison with previously cleared (K141934, K152008, K190911, K201084) cemented Physica Femoral components.
The analyses (e.g. drawings overlap and testing provided) demonstrated that device performance fulfill the intended use and are substantially equivalent to the predicate devices. The PoroTi coating of subject Porous Femoral components fulfills the conformity to the FDA guidelines and referenced standards and the analysis was performed on worst case components or constructs.
6
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of the new Physica Porous Femoral components to the predicate devices.
Conclusion
Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the Physica systems (including subject Physica Porous Femoral components) are substantially equivalent to the predicate devices identified in this premarket notification.