(20 days)
No
The document describes a modular knee implant system and its intended use. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies section also indicates that non-clinical and clinical testing were not necessary to demonstrate substantial equivalence, which is typical for a device that is a modification of a previously cleared device and does not introduce novel technology like AI/ML.
No.
This device is a modular knee system (knee implant) used in knee arthroplasty, which is a surgical procedure to replace a damaged knee joint. While it aims to restore function and alleviate conditions like arthritis, it is a replacement device, not a therapeutic device that delivers therapy or treatment in that sense.
No
Explanation: The provided text describes the Physica system as a modular knee system intended for use in knee arthroplasty for various degenerative joint conditions and deformities. It is a device used in surgical procedures (treatment), not for diagnosing conditions.
No
The device description explicitly states it is a "modular knee system" consisting of physical components like tibial liners, femoral components, tibial plates, patellar components, and tibial stems, made of materials like UHMWPE and LimaVit. This indicates it is a hardware 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 taken from the body.
- Device Description: The device is described as a modular knee system consisting of components like tibial liners, femoral components, tibial plates, patellar components, and tibial stems. These are all physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, the Physica system is a surgical implant, not 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 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.
Product codes
JWH, HRY
Device Description
Physica LMC Knee System is a modular knee system which consists of Physica LMC tibial liner, made of UHMWPE or LimaVit, used in combination with a Physica CR femoral component, Physica tibial plate, cemented or uncemented versions, Physica patellar component, made of standard UHMWPE or LimaVit and Physica tibial stem, that were cleared as part of the Physica Knee System in K141934, K151266 and K201084.
The Physica LMC knee system is intended to be used in patients with or without a functioning posterior cruciate ligament.
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 was not necessary to demonstrate substantial equivalence of the Physica LMC Knee System to the predicate devices.
Clinical testing was not necessary to demonstrate substantial equivalence of the Physica LMC Knee System to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
July 13, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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 % Lacey Harbour US Regulatory Manager Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006
Re: K211938
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: June 7, 2021 Received: June 23, 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., R.A.C. For 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
Image /page/2/Picture/0 description: The image shows the logo for Lima Corporate. The logo consists of a red abstract symbol on the left, followed by the word "Lima" in black. To the right of "Lima" is the word "Corporate" in gray, and below that is the phrase "Orthopaedic" in gray, followed by a red and black symbol and the word "motion" in black.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211938
Device Name
Physica LMC Knee 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
- 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 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.
Type of Use (Select one or both, as applicable)
Special 510(k) Physica LMC knee system June 7, 2021
3
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Orthopaedic motion
Prescription Use (Part 21 CFR 801 Subpart D)
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510(k) Summary
Date: June 7, 2021
| Manufacturer: | U.S. Contact Person: |
|---|---|
| LimaCorporate S.p.A. | |
| Via Nazionale, 52 | |
| 33038 – Villanova di San Daniele | |
| Udine - Italy | 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 |
Device Trade Name:
Physica LMC Knee System
| 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 | ||
| Physica LMC Knee System | HRY | Knee joint Femorotibial Metal/Polymer Semi-Constrained Cemented Prosthesis per 21 CFR 888.3530 |
Predicate Devices:
Physica LMC Knee System (K193284 and K201084).
Device Description:
Physica LMC Knee System is a modular knee system which consists of Physica LMC tibial liner, made of UHMWPE or LimaVit, used in combination with a Physica CR femoral component, Physica tibial plate, cemented or uncemented versions, Physica patellar component, made of standard UHMWPE or LimaVit and Physica tibial stem, that were cleared as part of the Physica Knee System in K141934, K151266 and K201084.
The Physica LMC knee system is intended to be used in patients with or without a functioning posterior cruciate ligament.
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
Special 510(k) Physica LMC Knee System June 7, 2021
5
Image /page/5/Picture/1 description: The image shows the logo for Lima Corporate. The logo consists of a red abstract symbol on the left, followed by the words "Lima Corporate" in black and gray. Below "Lima Corporate" are the words "Orthopaedic" and "motion" in gray and red.
- 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 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.
Comparable Features to Predicate Device(s)
This Special 510(k) describes modifications made to the information for use and surgical technique.
- replacing the statement "damaged or deficient" with the statement "with or without a . functioning" in the Product Information paragraph of the IFU.
- adding notes in the surgical technique from the indications of use for the LMC, and .
- "NOTE. Physica CR and KR are intended to be used in patients with a preserved . and well functioning PCL."
- . "NOTE. Physica LMC Liner is intended to be used with or without a functioning PCL."
- . "NOTE. Physica PS is intended to be used in situations where the PCL is absent or cannot be preserved."
- adding note in the surgical technique to elaborate further on the indications of use "NOTE. ● Without functioning PCL, the surgeon should evaluate the possibility of removing the PCL according to patient conditions while implanting the LMC liner."
Substantial Equivalence:
Special 510(k) Physica LMC Knee System June 7, 2021
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Image /page/6/Picture/1 description: The image shows the logo for LimaCorporate. The logo consists of a red abstract symbol on the left, followed by the word "Lima" in black and "Corporate" in gray. Below "Corporate" is the word "Orthopaedic" in gray, followed by a red abstract symbol and the word "motion" in black.
The Physica LMC Knee System is substantially equivalent to the predicate device cited on the previous page with respect to indications, design, function, and performance.
Non-Clinical Testing:
Non-Clinical testing was not necessary to demonstrate substantial equivalence of the Physica LMC Knee System to the predicate devices.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Physica LMC Knee System to the predicate devices.
Conclusion:
Based on the information contained within this submission, it is concluded that the Physica LMC Knee System labeling changes are substantially equivalent to the identified predicate devices.