Physica KR Liner and SMR Reverse Humeral Liner

K190911 · Limacorporate · JWH · Nov 26, 2019 · Orthopedic

Device Facts

• Record ID: K190911
• Device Name: Physica KR Liner and SMR Reverse Humeral Liner
• Applicant: Limacorporate
• Product Code: JWH · Orthopedic
• Decision Date: Nov 26, 2019
• Decision: SESE
• Submission Type: Special
• 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. Physica knee system is intended for cemented fixation. The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: - non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; - inflammatory degenerative joint disease such as rheumatoid arthritis; - treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods: - revision of a failed primary implant; - cuff tear arthropathy (CTA Heads only); - glenoid arthrosis without excessive glenoid bone loss: A1. A2 and B1 according to Walch classification (SMR Hybrid Glenoid only). The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

Device Story

Physica total knee and SMR shoulder systems comprise modular orthopedic implants for joint replacement. This submission introduces an alternative sterilization method (gamma radiation, min 25 kGy) for Physica KR and SMR Reverse Humeral UHMWPE liners. Devices are implanted by orthopedic surgeons in clinical/hospital settings. Implants restore joint function and alleviate pain caused by degenerative disease, fractures, or previous implant failure. Clinical benefit derived from mechanical joint reconstruction. No changes to device design, function, or materials; UHMWPE remains conventional (non-crosslinked).

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including sterilization validation, UHMWPE characterization, and mechanical testing.

Technological Characteristics

Materials: Ti6Al4V (ISO 5832-3, ASTM F1472), CoCrMo (ISO 5832-12, ASTM F1537), UHMWPE (ISO 5834-2, ASTM F648), PoroTi Titanium Coating (ASTM F1580), Tantalum (ISO 13782, ASTM F560). Modular orthopedic prosthesis components. Sterilization: Gamma radiation (min 25 kGy).

Indications for Use

Indicated for skeletally mature patients requiring knee arthroplasty for degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis), functional deformity, revision, or fracture management. Shoulder systems indicated for partial/total/revision replacement in patients with degenerative joint disease, rheumatoid arthritis, acute humeral head fractures, failed primary implants, cuff tear arthropathy, or glenoid arthrosis. Reverse shoulder indicated for rotator cuff deficient joints with severe arthropathy; requires functional deltoid muscle.

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 KR Knee System (K141934)
• SMR Shoulder System (K110598, K142139, K163397)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & 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 box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 26, 2019

LimaCorporate % David McGurl Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

Re: K190911

Trade/Device Name: Physica KR Liner and SMR Reverse Humeral Liner Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, HRY, PHX, KWS, MBF, KWT Dated: October 29, 2019 Received: October 29, 2019

Dear David McGurl:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Ting Song, Ph.D. 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)

K190911

Device Name

Physica KR Liner and SMR Reverse Humeral Liner

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, 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.

Physica knee system is intended for cemented fixation

The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

- non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; ●
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- . treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods:
- revision of a failed primary implant;
- . cuff tear arthropathy (CTA Heads only);
- glenoid arthrosis without excessive glenoid bone loss: A1. A2 and B1 according to Walch . classification (SMR Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented use as specified in the following table.

In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral

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stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner, the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

| System | | | | Use | |
|--------|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----|------------|
| A | R | Components | Material | Cem | Not<br>Cem |
| ● | ● | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | |
| ● | ● | SMR Stems (Cementless Finned, Cementless Revision) | Ti6Al4V | | X |
| ● | | SMR Humeral Bodies (Trauma, Finned) | Ti6Al4V | X | X |
| ● | ● | SMR Reverse Humeral Body | Ti6Al4V | X | X |
| ● | ● | Humeral Extension | Ti6Al4V | X | X |
| ● | | SMR Humeral Heads (Standard*, CTA) | CoCrMo | X | X |
| ● | | SMR Adaptor Tapers (Neutral, Eccentric) | Ti6Al4V | X | X |
| ● | | SMR CTA Head Adaptor for Reverse Humeral Body | Ti6Al4V | X | X |
| | ● | SMR Glenospheres | CoCrMo | | X |
| | ● | SMR Connectors* | Ti6Al4V | | X |
| | ● | Reverse Liners | UHMWPE | X | X |
| ● | | SMR Cemented Glenoids | UHMWPE | X | |
| ● | | SMR 3 Pegs Cemented Glenoids | UHMWPE | X | |
| ● | ●* | SMR Hybrid Glenoid | UHMWPE+Ti6Al4V+Ta | X | X |
| | ● | SMR Hybrid Glenoid Reverse Baseplate + Screw | Ti6Al4V | | X |
| ● | ● | SMR Metal Back Glenoids | Ti6Al4V+PoroTi | X* | X* |
| ● | ● | SMR TT Metal Back Baseplate | Ti6Al4V | X* | X* |
| ● | ● | SMR TT Metal Back Peg | Ti6Al4V | X | X |
| ● | | SMR Metal Back Liner | UHMWPE | X* | X* |
| ●* | ● | SMR Bone screws | Ti6Al4V | | X |
| | | Material Standards | | | |
| | | Ti6Al4V (ISO 5832-3 - ASTM F1472) - CoCrMo (ISO 5832-12 - ASTM F1537) - UHMWPE (ISO 5834-2 - ASTM F648) -<br>PoroTi Titanium Coating (ASTM F1580) - Ta (ISO13782 - ASTM F560) | | | |

## A= Anatomic / R=Reverse

*NOTE:

- In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic ● Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.
- The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR ● Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
- SMR lateralized connectors are not indicated for use with glenoid bone grafting techniques. ●
- In the US the SMR TT Metal Back Baseplate used as part of the SMR Anatomic Shoulder ● Replacement, is intended for use with bone cement and should be used without bone screws; while when used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
- If a SMR Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient ● can be revised by removing the polyethylene baseplate, leaving the metal peg in place and by connecting it to the SMR Hybrid Glenoid Reverse Baseplate. The SMR Hybrid Glenoid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation.

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- The Dia. 50, 52 and 54 mm Humeral Heads with + 3mm increased height cannot be coupled ● to the Long Adaptor Tapers (both concentric and eccentric).
- The Dia. 52 and 54 mm Humeral Heads with + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY

| Device Trade Name: | Physica KR Liner and SMR Reverse Humeral Liner |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | LimaCorporate<br>Via Nazionale, 52<br>33038 Villanova di San Daniele del Friuli<br>Udine, Italy |
| Contact: | Mr. Roberto Gabetta<br>Regulatory Manager<br>Phone: [phone]<br>Email: [e-mail] |
| Prepared by: | Mr. Dave McGurl<br>Director, Regulatory Affairs<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1050 K Street NE, Suite 1000<br>Washington, DC 20005<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | November 26, 2019 |
| Classification: | 21 CFR 888.3560 Knee joint patellofemorotibia polymer/metal/polymer semi-constrained cemented prosthesis.<br>21 CFR 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.<br>21 CFR 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.<br>21 CFR 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.<br>21 CFR 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis |
| Class: | II |
| Product Code: | JWH, HRY, PHX, KWS, MBF, KWT |
| Predicate Devices: | Physica KR Knee System (K141934)<br>SMR Shoulder System (K110598, K142139, K163397) |

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# 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, 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. ●

Physica knee system is intended for cemented fixation.

The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

- non-inflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- treatment of acute fractures of the humeral head that cannot be treated with other fracture ● fixation methods:
- revision of a failed primary implant;
- cuff tear arthropathy (CTA Heads only);
- glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to . Walch classification (SMR Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

In the Anatomic shoulder the humeral construct consists of the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

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The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

| System | | | | Use | |
|--------|----|----------------------------------------------------|-------------------|-----|------------|
| A | R | Components | Material | Cem | Not<br>Cem |
| • | • | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | |
| • | • | SMR Stems (Cementless Finned, Cementless Revision) | Ti6Al4V | | X |
| • | | SMR Humeral Bodies (Trauma, Finned) | Ti6Al4V | X | X |
| • | • | SMR Reverse Humeral Body | Ti6Al4V | X | X |
| • | • | Humeral Extension | Ti6Al4V | X | X |
| • | | SMR Humeral Heads (Standard*, CTA) | CoCrMo | X | X |
| • | | SMR Adaptor Tapers (Neutral, Eccentric) | Ti6Al4V | X | X |
| • | | SMR CTA Head Adaptor for Reverse Humeral Body | Ti6Al4V | X | X |
| | • | SMR Glenospheres | CoCrMo | | X |
| | • | SMR Connectors* | Ti6Al4V | | X |
| | • | Reverse Liners | UHMWPE | X | X |
| • | | SMR Cemented Glenoids | UHMWPE | X | |
| • | | SMR 3 Pegs Cemented Glenoids | UHMWPE | X | |
| • | •* | SMR Hybrid Glenoid | UHMWPE+Ti6Al4V+Ta | X | X |
| | • | SMR Hybrid Glenoid Reverse Baseplate + Screw | Ti6Al4V | | X |
| • | • | SMR Metal Back Glenoids | Ti6Al4V+PoroTi | X* | X* |
| • | • | SMR TT Metal Back Baseplate | Ti6Al4V | X* | X* |
| • | • | SMR TT Metal Back Peg | Ti6Al4V | X | X |
| • | •* | SMR Metal Back Liner | UHMWPE | X* | X* |
| •* | • | SMR Bone screws | Ti6Al4V | | X |

T6A14V (ISO 5832-3 - ASTM F1472) - CoCrMo (ISO 5832-12 - ASTM F1537) - UHMWPE (ISO 5834-2 - ASTM F648) -PoroTi Titanium Coating (ASTM F1580) - Ta (ISO13782 - ASTM F560)

A= Anatomic / R=Reverse

*NOTE:

- In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR ● Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.
- . The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
- SMR lateralized connectors are not indicated for use with glenoid bone grafting techniques.
- In the US the SMR TT Metal Back Baseplate used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws; while when used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.

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- If a SMR Hybrid Glenoid is in place and revision to a reverse prosthesis is required, ● the patient can be revised by removing the polyethylene baseplate. leaving the metal peg in place and by connecting it to the SMR Hybrid Glenoid Reverse Baseplate. The SMR Hybrid Glenoid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation.
- . The Dia. 50, 52 and 54 mm Humeral Heads with + 3mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).
- The Dia. 52 and 54 mm Humeral Heads with + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).

## Device Description:

The Physica System is a total knee system and the SMR Reverse is a reverse shoulder system.

The purpose of the Special 510(k) is to add an alternative sterilization method for the Physica KR Liner and SMR Reverse Humeral Liners. Both systems utilize conventional (non-crosslinked) UHMWPE liners (ISO 5834-2 ASTM F648). The liners can be sterilized using a minimum gamma radiation dose of 25 kGy.

#### Substantial Equivalence:

The Physica KR Liner and SMR Reverse Humeral Liner is substantially equivalent to the predicate devices cited on the previous page with respect to indications, design, function, and performance.

#### Preclinical Testing:

The following activities were performed:

- Sterilization validation
- UHMWPE Characterization
- Mechanical Testing ●

## Clinical Testing:

Clinical testing was not necessary to support equivalence.

#### Conclusion:

The Physica KR Liner and SMR Reverse Humeral Liner possesses the same intended use and technological characteristics as the predicate devices. Therefore, the Physica KR Liner and SMR Reverse Humeral Liner is substantially equivalent for its intended use.