· 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.

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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called "Physica Porous Femoral Components." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific performance acceptance criteria via a clinical study with a detailed test set, ground truth, or expert review.

Therefore, the document does not contain the information requested regarding acceptance criteria met by a study that proves the device meets them. Specifically:

No table of acceptance criteria and reported device performance: The document does not define specific performance metrics or acceptance thresholds that the device was tested against in a clinical setting.
No sample size used for the test set or data provenance: There is no clinical test set described.
No number of experts or their qualifications for ground truth: Since no clinical test set is described, there's no mention of experts establishing ground truth for it.
No adjudication method for the test set: Not applicable as there's no clinical test set.
No multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "Clinical testing was not necessary to demonstrate substantial equivalence of the new Physica Porous Femoral components to the predicate devices." This means no human-in-the-loop study was conducted.
No standalone (algorithm only) performance study: This is not an AI/algorithm-based device; it's a knee prosthesis component.
No type of ground truth used: Not applicable as there's no clinical test.
No sample size for the training set: Not applicable as this is a physical device and not an AI/ML model.
No description of how ground truth for the training set was established: Not applicable.

What the document does state regarding demonstrating equivalence:

The submission for the Physica Porous Femoral Components focuses on demonstrating substantial equivalence primarily through non-clinical testing and comparison of technological characteristics.

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."
Comparison of technological characteristics: The document asserts that "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."

In essence, the "study" proving the device meets requirements for market clearance in this case is a non-clinical bench testing and design control process to ensure the new manufacturing of the porous coating is equivalent to a previously cleared version, which itself would have established safety and effectiveness through its own predicate or data. No new clinical or human performance data was required for this specific 510(k) submission.

Summary

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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.

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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

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Indications for Use

Submission Number (if known)

K243615

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.

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.

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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-coateduncemented prosthesis per 21 CFR 888.3565

Description

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;

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· 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.

Tibial liners can be used with cemented or uncemented tibial or femoral components.

Predicate Devices

Device name	Cleared via	Company
Physica Porous FemoralComponent	K210554 (last cleared inthe 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.

Regulation Number and Section

§ 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.