(65 days)
No
The document describes a total knee replacement system and its components, focusing on materials, intended use, and mechanical testing. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The Physica system is a total knee replacement system with indications including the treatment of various degenerative joint diseases, functional deformity, and fractures, which are all conditions that fall under the umbrella of therapeutic interventions.
No.
The device described is a total knee replacement system, which is a medical implant used for treatment in patients with various knee conditions, not for diagnosing them.
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, made of materials like CoCrMo alloy and UHMWPE. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for knee arthroplasty to treat various knee conditions. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a total knee replacement system consisting of physical components like femoral, tibial, and patellar parts made of materials like CoCrMo alloy and UHMWPE. These are physical implants, not reagents, instruments, or systems used to examine specimens.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device is directly implanted into the patient.
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
- o traumatic arthritis, and
- o avascular necrosis (not applicable to Physica TT Tibial Plate);
- · 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, PS Pro and HPS components are also indicated for: -
· Absent or not-functioning posterior cruciate ligament;
-
· Severe antero-posterior instability of the knee joint.
Additional indications for Physica HPS component are:
- · Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- · The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
- · Collagen disorders, and/or avascular necrosis of the femoral condyle.
- · Moderate varus, valgus, or flexion deformities.
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.
Product codes
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 Patellar component are optional to be used as required for each individual patient and as allowed in the Instructions for Use.
The Physica PS PRO Femoral component is made of CoCrMo alloy; Physica PS, PS PRO and HPS Tibial liners are made of cross-linked UHMWPE with Vitamin E.
The PS PRO Femoral component is intended to be used with bone cement.
The addition of the High Posterior Stabilized (HPS) LimaVit articular surface will provide the surgeon with a more constrained option in obtaining moderate varus/valgus and/or internal/external rotation constraint compared to Physica system posterior stabilized articular surfaces.
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
Non-clinical testing: Mechanical safety of the subject Physica PS PRO Femoral component and PS, PS PRO and HPS Tibial liners were confirmed through a comparison with previously cleared (K141934, K152008, K201084) Physica system 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.
Clinical testing: Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices to the predicate devices.
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
December 17, 2021
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 & 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 US Regulatory Manager Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington, Texas 76006
Re: K213381
Trade/Device Name: Physica system Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH. HRY Dated: September 20, 2021 Received: October 13, 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
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. 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
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K213381
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
- o traumatic arthritis, and
- avascular necrosis (not applicable to Physica TT Tibial Plate);
- 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, PS Pro and HPS components are also indicated for: -
Absent or not-functioning posterior cruciate ligament;
-
· Severe antero-posterior instability of the knee joint.
Additional indications for Physica HPS component are:
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
- · Collagen disorders, and/or avascular necrosis of the femoral condyle.
- · Moderate varus, valgus, or flexion deformities.
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.
3
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)
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4
Summary of Safety and Effectiveness
Date: September 20th , 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: Total Knee prosthesis.
Classification Name:
| Product Code | Regulation and Classification Name |
|---|---|
| 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 Patellar component are optional to be used as required for each individual patient and as allowed in the Instructions for Use.
The Physica PS PRO Femoral component is made of CoCrMo alloy; Physica PS, PS PRO and HPS Tibial liners are made of cross-linked UHMWPE with Vitamin E.
The PS PRO Femoral component is intended to be used with bone cement.
The addition of the High Posterior Stabilized (HPS) LimaVit articular surface will provide the surgeon with a more constrained option in obtaining moderate varus/valgus and/or internal/external rotation constraint compared to Physica system posterior stabilized articular surfaces.
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
- o traumatic arthritis, and
- o avascular necrosis (not applicable to Physica TT Tibial Plate);
- · Inflammatory degenerative joint disease including rheumatoid arthritis;
- · Correction of functional deformity;
5
- · 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, PS Pro and HPS components are also indicated for: -
· Absent or not-functioning posterior cruciate ligament;
-
· Severe antero-posterior instability of the knee joint.
Additional indications for Physica HPS component are:
- · Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- · The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
- · Collagen disorders, and/or avascular necrosis of the femoral condyle.
- · Moderate varus, valgus, or flexion deformities.
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 | LIMACORPORATE | Physica system | K152008, K201084 |
| 2 | ZIMMERBIOMET | Zimmer | |
| Persona® | |||
| Personalized | |||
| knee system | K123459 |
Predicate Devices:
Summary of technology comparison:
The intended use, design, and materials of the subject Physica PS PRO Femoral component and PS, PS PRO and HPS Tibial liners (part of Physica system) are substantially equivalent to those of the predicate devices. Design Control Activities have
6
been successfully completed.
Non-clinical testing
Mechanical safety of the subject Physica PS PRO Femoral component and PS, PS PRO and HPS Tibial liners were confirmed through a comparison with previously cleared (K141934, K152008, K201084) Physica system 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.
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices to the predicate devices.
Conclusion
Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the Physica system is substantially equivalent to the predicate devices identified in this premarket notification.