(26 days)
No
The document describes a knee arthroplasty system and its components, focusing on materials, intended use, and mechanical testing. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device is a knee implant used in arthroplasty to replace or revise knee joints, which functions to restore joint mechanics rather than provide a therapeutic effect on a disease or condition.
No
This device is described as an implantable prosthetic system (Physica system, Physica LMC component, Physica PS, PS Pro and HPS components, AMF Revision TT Cones, Femoral, tibial and patellar components of the Physica system, Physica Porous Femoral components, Physica TT Tibial Plates, Tibial liners) used in knee arthroplasty, and its intended use is for treatment and revision procedures, not for diagnosis.
No
The device description explicitly states it is a "Physica Porous Femoral Component," which is a physical implant used in knee arthroplasty. The submission is for adding an additional coating vendor for these components, not for a software product.
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 knee arthroplasty. It addresses conditions like osteoarthritis, rheumatoid arthritis, deformities, and fractures. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a "Physica system" with components like femoral, tibial, and patellar implants, and cones. These are physical implants designed to replace or augment parts of the knee joint.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
In summary, the Physica system is a surgical device used for the treatment of knee conditions, not a diagnostic device used to test samples outside the body.
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, valqus, 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 (comma separated list FDA assigned to the subject device)
MBH
Device Description
Physica Porous Femoral Components have been cleared via K210554 with a Porous coating performed by a supplier. With this 510(k) submission, Limacorporate intends to add an additional coating vendor for these components. No other change is introduced on the Physica Porous Femoral Components: Intended use, design, material, sterilization, packaging and principle of operation are unchanged compared to the information approved in K210554.
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 and morphological characteristics of the coating of the subject cementless Physica Porous Femoral components were confirmed through a comparison with previously cleared (K210554) cementless Physica Porous Femoral components. 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 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.
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.
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Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 18, 2024
Limacorporate S.p.A. Massimo Rosso Senior Regulatory Affairs Processes Specialist Via Nazionale, 52 Villanova di San Daniele del Friuli, UD 33038 Italy
Re: K243615
Trade/Device Name: Physica Porous Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH Dated: November 22, 2024 Received: November 22, 2024
Dear Massimo Rosso:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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, Digitally signed by Peter G. Peter G. Allen -Allen -S S Date: 2024.12.18 09:23:27 -05'00' For Lixin Liu, PhD 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
3
Indications for Use
Submission Number (if known)
Device Name
Physica Porous Femoral Components
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, valqus, 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.
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.
4
Summarv of Safety and Effectiveness
Date: September 27, 2024
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy
U.S. Contact Person: Sherri Mellingen Sherri.mellingen@enovis.com Enovis 9800 Metric Blvd Austin, Texas 78758, USA
Trade name: Physica Porous Femoral Components
Common Name: Total 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 |
Description
Physica Porous Femoral Components have been cleared via K210554 with a Porous coating performed by a supplier. With this 510(k) submission, Limacorporate intends to add an additional coating vendor for these components. No other change is introduced on the Physica Porous Femoral Components: Intended use, design, material, sterilization, packaging and principle of operation are unchanged compared to the information approved in K210554.
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;
5
· 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.
Predicate Devices
| Device name | Cleared via | Company |
|---|---|---|
| Physica Porous Femoral | ||
| Component | K210554 (last cleared in | |
| the system K213381) | LimaCorporate S.p.A |
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 and morphological characteristics of the coating of the subject cementless Physica Porous Femoral components were confirmed through a comparison with previously cleared (K210554) cementless Physica Porous Femoral components. 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.
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Conclusion
of intended use, use, materials, summary Based upon a a comparison of technological characteristics, and preclinical testing, the Physica system (including subject Physica Porous Femoral components) is substantially equivalent to the predicate devices identified in this premarket notification.