Physica LMC Knee System

K193284 · Lima Corporate S.P.A. · JWH · Jan 31, 2020 · Orthopedic

Device Facts

• Record ID: K193284
• Device Name: Physica LMC Knee System
• Applicant: Lima Corporate S.P.A.
• Product Code: JWH · Orthopedic
• Decision Date: Jan 31, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

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. 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.

Device Story

Physica LMC Knee System is a modular, cemented total knee arthroplasty prosthesis. It consists of a Physica LMC tibial liner used with Physica CR femoral components and Physica tibial plates; optional patellar components and tibial stems are available. Used by orthopedic surgeons in clinical settings to replace damaged knee joint surfaces. The device restores joint function and stability in patients with degenerative disease or deformity. It functions as a semi-constrained mechanical implant. Clinical benefit includes pain relief and improved mobility for patients with severe knee pathology.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including contact area/pressure (ASTM F2083), wear testing (ISO 14243), and constraint testing (ASTM F1223).

Technological Characteristics

Modular knee prosthesis; semi-constrained cemented design. Materials and design are equivalent to predicate systems. Testing performed per ASTM F2083, ASTM F1223, and ISO 14243 standards. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients undergoing knee arthroplasty for non-inflammatory/inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, rheumatoid arthritis), functional deformity correction, revision procedures, or fracture treatment. Physica LMC components specifically for moderate varus, valgus, or flexion deformities. Physica PS components for ligamentous instability (with functional collateral ligaments) or absent/non-functioning posterior cruciate ligament.

Regulatory Classification

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).

Predicate Devices

• Physica Knee System (K151266, K141934, K152008)
• VANGUARD (K050222, K113550)
• PERSONA (K150090)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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) |
|-----------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt"> <b> </b> </span> <span style="font-size:10pt"> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span style="font-size:10pt"> </span> <span style="font-size:10pt"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 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 [e-mail] Limacorporate S.p.A. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006 USA www.limacorporate.com Office Phone: [phone] ext.200 Cell Phone: [phone] FAX: [phone]

| Product | Product Code | Regulation and Classification Name |
|-------------------------|--------------|---------------------------------------------------------------------------------------------------------------------|
| Physica LMC knee System | JWH | Knee joint Patellofemorotibial<br>Polymer/Metal/Polymer Semi-Constrained<br>Cemented Prosthesis per 21 CFR 888.3560 |
| | HRY | Knee joint Femorotibial Metal/Polymer<br>Semi-Constrained Cemented Prosthesis per<br>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.