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 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.

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.

AI/ML Overview

The provided text is a 510(k) premarket notification for artificial joint components (knee and shoulder liners). It focuses on demonstrating substantial equivalence to previously cleared devices, primarily through preclinical testing and does not describe a clinical study or a study involving AI/software.

Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, expert involvement, and AI performance cannot be extracted from this document.

Here's what can be gathered, addressing the relevant parts of your request:

1. A table of acceptance criteria and the reported device performance:

The document states: "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." It then lists the following preclinical tests:

Acceptance Criteria Category	Reported Device Performance (Summary)	Details Provided in Document
Sterilization Validation	Met established sterilization requirements.	"Sterilization validation" was performed, indicating the new sterilization method (minimum gamma radiation dose of 25 kGy) was validated. Implies acceptance criteria related to sterility assurance level (SAL) were met.
UHMWPE Characterization	Materials meet industry standards.	"UHMWPE Characterization" was performed. This would involve tests to confirm material properties (e.g., molecular weight, density, mechanical properties) meet the specifications for conventional UHMWPE (ISO 5834-2 ASTM F648). Implies acceptance criteria related to material specifications were met.
Mechanical Testing	Device mechanically performs as intended and is comparable to predicate.	"Mechanical Testing" was performed. This would have involved tests such as wear, fatigue, static strength, etc., to demonstrate the device's mechanical integrity and performance is equivalent to the predicate devices under simulated physiological conditions. Implies acceptance criteria related to biomechanical performance were met.

Important Note: The document does not provide specific numerical acceptance criteria (e.g., "wear rate must be < X mg") or the exact numerical results for each test. It only broadly states that the device is "substantially equivalent" based on these tests.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated. The tests are preclinical (sterilization, material characterization, mechanical testing), not clinical trials involving human subjects or large data sets. The sample size would refer to the number of physical liners or material samples tested in a lab.
Data Provenance: The preclinical tests were performed by LimaCorporate (Italy). The document doesn't specify if external labs were used, but the manufacturer is based in Italy. The data is from preclinical laboratory testing, not human data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: This filing describes preclinical performance testing of a physical medical device. It does not involve "ground truth" derived from expert consensus on medical images or clinical outcomes. The "ground truth" for these tests would be the established scientific and engineering principles, material standards (e.g., ISO, ASTM), and validated test methods.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable: Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert readers for subjective interpretations. This document describes objective preclinical laboratory tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable: No MRMC study was done, as this submission is for a physical medical device (joint liners), not an AI/software device. The document explicitly states: "Clinical testing was not necessary to support equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable: This device is not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Preclinical Test Benchmarks/Standards: The "ground truth" for the preclinical tests would be defined by established engineering and material standards (e.g., ISO, ASTM), recognized test methodologies (e.g., for wear testing, fatigue testing, sterilization validation), and historical performance data of predicate devices. For example, for "UHMWPE Characterization," the ground truth would be the known, acceptable material properties defined by ASTM F648 or ISO 5834-2.

8. The sample size for the training set:

Not Applicable: There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not Applicable: See point 8.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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.

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	NotCem
●	●	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) -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:	LimaCorporateVia Nazionale, 5233038 Villanova di San Daniele del FriuliUdine, Italy
Contact:	Mr. Roberto GabettaRegulatory ManagerPhone: +39 338 6439379Email: roberto.gabetta@limacorporate.com
Prepared by:	Mr. Dave McGurlDirector, Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NE, Suite 1000Washington, DC 20005Phone: 202.552.5800dmcgurl@mcra.com
Date Prepared:	November 26, 2019
Classification:	21 CFR 888.3560 Knee joint patellofemorotibia polymer/metal/polymer semi-constrained cemented prosthesis.21 CFR 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.21 CFR 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.21 CFR 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.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)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 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	NotCem
•	•	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.

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.

Regulation Number and Section

§ 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.