(235 days)
Not Found
No
The summary describes a standard total knee replacement system and does not mention any AI or ML components or functionalities.
Yes
The device is a total knee replacement system, which functions as a therapeutic device by correcting functional deformity and treating degenerative joint diseases or fractures.
No
This device is described as a total knee replacement system, which is a therapeutic device intended for implantation, not for diagnosing medical conditions.
No
The device description explicitly states it is a "total knee replacement system consisting of a Femoral component, Tibial plate, Tibial stem and patella," which are physical hardware components.
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 replacing parts of the knee joint in patients with various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a total knee replacement system consisting of physical components like femoral, tibial, and patellar parts. These are physical implants, not reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
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
- osteoarthritis
- 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, Physica PS components are also indicated for: -
· Absent or not-functioning posterior cruciate ligament;
-
· Severe antero-posterior instability of the knee joint.
Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of the TT Tibial Plate that is intended for uncemented use. Tibial liners can be used with cemented tibial components.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH, HRY
Device Description
The Physica system is a total knee replacement system consisting of a Femoral component, Tibial plate, Tibial stem and patella; the Tibial stem and Patella components are optional to be used as required for each individual patient.
Tibial liners and Patellar components made of conventional UHMWPE and cross-linked UHMWPE with Vitamin E are provided as part of the Physica system. The Tibial Plate is provided in cemented and uncemented versions.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices in:
- Wear test;
- Contact areas and pressures at tibio-femoral and patello-femoral interfaces; .
- Test on the locking strength between the tibial plate and the tibial liner; ●
- Fatigue testing of the tibial plate; ●
- Fatigue testing of distal features of tibial plate. ●
Since the tibial liners and patellar components manufactured from cross-linked UHMWPE with Vit. E have an equivalent design and geometry to the predicate tibial liners and patellar components, the ROM of the subject devices when used with the previously cleared femoral components is the same as the ROM provided by the predicate Physica system tibial liners and patellar components.
Clinical testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices 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.
K141934, K193284, K113550, K072160
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
§ 888.3565 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
December 14, 2020
Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
LimaCorporate S.p.A. % Stephen Peoples President Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814
Re: K201084
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: November 9, 2020 Received: November 10, 2020
Dear Stephen Peoples:
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. 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
Indications for Use
510(k) Number (if known) K201084
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
- osteoarthritis
- 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, Physica PS components are also indicated for: -
· Absent or not-functioning posterior cruciate ligament;
-
· Severe antero-posterior instability of the knee joint.
Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of the TT Tibial Plate that is intended for uncemented use. Tibial liners can be used with cemented tibial components.
| 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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3
Summary of Safety and Effectiveness
Date: December 14, 2020
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy
U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant SPeoplesVMD@gmail.com PEOPLES & ASSOCIATES CONSULTING, LLC 411 Auditorium Blvd. Winona Lake, IN 46590 Phone: 260-645-0327 FAX: +39 0432945512
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 |
Closcification Name:
Description:
The Physica system is a total knee replacement system consisting of a Femoral component, Tibial plate, Tibial stem and patella; the Tibial stem and Patella components are optional to be used as required for each individual patient.
Tibial liners and Patellar components made of conventional UHMWPE and cross-linked UHMWPE with Vitamin E are provided as part of the Physica system. The Tibial Plate is provided in cemented and uncemented versions.
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
- 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.
4
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.
Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of the TT Tibial Plate that is intended for uncemented use. Tibial liners can be used with cemented or uncemented tibial components.
Predicate Devices:
| Applicant | Device name | Cleared via |
|---|---|---|
| LIMACORPORATE S.P.A | PHYSICA SYSTEM | K141934, |
| K193284 | ||
| BIOMET MANUFACTURING CORP. | VANGUARD COMPLETE KNEE SYSTEM | K113550 |
| ZIMMER, INC. | NEXGEN TRABECULAR METAL TIBIAL TRAY | K072160 |
Summary of technology comparison:
The intended use, design, and materials of the TT Tibial Plate and the tibial liners and patellar components manufactured from cross-linked UHMWPE with Vit. E are substantially equivalent to those of the predicate devices. Design Control Activities have been successfully completed.
Non-clinical testing:
Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices in:
- Wear test;
- Contact areas and pressures at tibio-femoral and patello-femoral interfaces; .
- Test on the locking strength between the tibial plate and the tibial liner; ●
- Fatigue testing of the tibial plate; ●
- Fatigue testing of distal features of tibial plate. ●
Since the tibial liners and patellar components manufactured from cross-linked UHMWPE with Vit. E have an equivalent design and geometry to the predicate tibial liners and patellar components, the ROM of the subject devices when used with the previously cleared femoral components is the same as the ROM provided by the predicate Physica system tibial liners and patellar components.
Clinical testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices to the predicate devices.
5
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.