(65 days)
Not Found
No
The summary describes a modular knee implant system and its mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
This device is a total knee system, indicated for use in knee arthroplasty to treat various degenerative joint diseases and correct functional deformities, which are all therapeutic interventions designed to alleviate symptoms, improve function, or correct a medical condition.
No
Explanation: The device is a total knee system intended for knee arthroplasty in skeletally mature patients with various degenerative joint diseases, deformities, or fractures. It is a treatment device, not a diagnostic one, as it does not diagnose conditions but rather replaces or corrects anatomical structures.
No
The device description clearly states that the Physica LMC knee system is a modular knee system consisting of physical components like tibial liners, femoral components, tibial plates, patellar components, and tibial stems. These are hardware components, not software.
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 a damaged knee joint. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a modular knee system consisting of physical components (tibial liner, femoral components, tibial plate, patellar component, tibial stem) intended for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
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.
Additional indications for Physica LMC component are:
- · Moderate varus, valgus, or flexion deformities
Additional indications for Physica PS components are:
· Iigamentous instability requiring implant bearing surface geometries with increased constraint (preserved and well functioning collateral ligaments are required);
· absent or not-functioning posterior cruciate ligament.
Product codes (comma separated list FDA assigned to the subject device)
JWH, HRY
Device Description
Physica LMC knee system is a modular knee system which consists of a Physica LMC tibial liner used in combination with the Physica CR femoral components (K151266) and the Physica tibial plate (K141934); the Physica patellar component and the Physica tibial stem, cleared in K141934, can optionally be used with the Physica LMC knee system. The Physica LMC knee system components are intended to be used with bone cement.
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:
Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices in:
- Contact area / pressure at the femoral component and tibial liner coupling (FDA guideline, ASTM F2083)
- Wear of the articulating surfaces (ISO 14243)
- Constraint of the femoral component and tibial liner coupling (FDA guideline, ASTM F1223)
Clinical testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the new Physica LMC knee system 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.
K151266, K141934, K152008, K050222, K113550, K150090
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
January 31, 2020
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and 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: K193284
Trade/Device Name: Physica LMC Knee 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: November 15, 2019 Received: November 27, 2019
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 (OS) 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 Song 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
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Indications for Use
510(k) Number (if known) K193284
Device Name Physica LMC knee system
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.
Additional indications for Physica LMC component are:
- · Moderate varus, valgus, or flexion deformities
Additional indications for Physica PS components are:
· Iigamentous instability requiring implant bearing surface geometries with increased constraint (preserved and well functioning collateral ligaments are required);
· absent or not-functioning posterior cruciate ligament.
| 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: January 27, 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 | Product Code | Regulation and Classification Name |
|---|---|---|
| Physica LMC knee System | 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:
Physica LMC knee system is a modular knee system which consists of a Physica LMC tibial liner used in combination with the Physica CR femoral components (K151266) and the Physica tibial plate (K141934); the Physica patellar component and the Physica tibial stem, cleared in K141934, can optionally be used with the Physica LMC knee system. The Physica LMC knee system components are intended to be used with bone cement.
Intended 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. ●
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Additional indications for Physica LMC component are:
-
Moderate varus, valgus, or flexion deformities
Additional indications for Physica PS components are: -
ligamentous instability requiring implant bearing surface geometries with increased ● constraint (preserved and well functioning collateral ligaments are required);
-
absent or not-functioning posterior cruciate ligament. ●
| Predicate Devices: | |
|---|---|
| Company | Device name | Cleared via |
|---|---|---|
| LIMACORPORATE | Physica Knee System | K151266, K141934, K152008 |
| ZIMMER | VANGUARD® | K050222, K113550 |
| ZIMMER | PERSONA® | K150090 |
Summary of technology comparison:
The intended use, design, and materials of Physica LMC knee system are substantially equivalent to the ones 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:
- Contact area / pressure at the femoral component and tibial liner coupling (FDA guideline, ASTM F2083)
- Wear of the articulating surfaces (ISO 14243) ●
- Constraint of the femoral component and tibial liner coupling (FDA guideline, ASTM ● F1223)
Clinical testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the new Physica LMC knee system to the predicate devices.