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).

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 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.

Device Description

The SMR 3-Pegs Glenoids are made from conventional UHMWPE. They are intended for cemented fixation only.

The SMR 3-Pegs Glenoids are available in four sizes: size Small and Standard have been previously cleared for market via premarket notification K130642. The only difference between the subject SMR 3-Pegs Glenoids and those cleared via K130642 is the size offering: the subject device is offered in size Extra-Small and Large.

The SMR 3-Pegs Glenoids are characterized by an articulating surface with a radius of curvature greater than the corresponding humeral head. This mismatch allows for translation of the head in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has three pegs for fixation in the glenoid.

The SMR 3-Pegs Glenoids are designed to articulate with the Limacorporate SMR humeral heads indicated for use in total shoulder replacement.

AI/ML Overview

This document describes a 510(k) premarket notification for the "SMR 3-Pegs Glenoids" orthopedic implant. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process does not typically involve the rigorous clinical trials or AI performance evaluations characteristic of novel medical devices. Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable to this type of submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

For a 510(k), the "acceptance criteria" are typically related to demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing for mechanical properties and the device's intended use, design, and materials. Clinical performance, in the sense of patient outcomes, is generally not required if substantial equivalence can be shown through other means.

In this case, the acceptance criteria are met by demonstrating mechanical equivalence to previously cleared devices.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Non-clinical Testing)
Intended Use: Comparable to predicate devices	Confirmed
Design: Comparable to predicate devices	Confirmed
Materials: Comparable to predicate devices	Confirmed (UHMWPE, Ti6Al4V, CoCrMo, PoroTi)
Mechanical Performance:	Demonstrated ability to perform substantially equivalent to predicate devices in:
- Static Evaluation of Glenoid Locking Mechanism in Shear (ASTM F1829)	Met
- Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028)	Met
- Range of Motion (ASTM F1378)	Met

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable in the context of clinical patient data. The "test set" here refers to the mechanical tests performed on the physical devices. The document does not specify the number of devices tested for each mechanical evaluation (ASTM F1829, F2028, F1378).
Data Provenance: The mechanical testing was conducted by the manufacturer, Limacorporate S.p.A. in Italy. It's non-clinical bench testing, not retrospective or prospective patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: Not applicable. For mechanical testing, the "ground truth" is established by adherence to recognized international standards (e.g., ASTM standards) and validated testing methodologies. It does not involve human expert consensus on clinical outcomes or image interpretations.
Qualifications of Experts: N/A. The "experts" would be engineering and quality control professionals overseeing the mechanical testing, ensuring compliance with standards.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1) is relevant for studies involving human interpretation of data, particularly medical imaging, where discrepancies need resolution. For mechanical testing, the results are quantitative measurements against predefined thresholds specified in the ASTM standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No. This study type is highly relevant for AI-powered diagnostic devices to assess how AI assists human readers. This submission is for a physical orthopedic implant and does not involve AI assistance for interpretation.
Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Standalone Performance: Not applicable. This device is a physical implant; there is no algorithm or AI component to assess.

7. Type of Ground Truth Used:

Ground Truth Type: For this submission, the "ground truth" is defined by the acceptance criteria established by recognized industry standards (ASTM) for the mechanical performance of the glenoid components. It is not clinical expert consensus, pathology, or outcomes data, as such data was deemed "not necessary to demonstrate substantial equivalence."

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable. There is no AI model being trained for this device.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set: Not applicable, as there is no training set or AI involved.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

April 6, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Limacorporate S.p.A. % Dr. Stephen Peoples President Peoples & Associates Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814

Re: K153722

Trade/Device Name: SMR 3-Pegs Glenoids Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: March 3, 2016 Received: March 9, 2016

Dear Dr. Peoples:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K153722

Device Name SMR 3-Pegs Glenoids

Indications for Use (Describe)

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).

In the Anatomic shoulder the humeral 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 or a metal back assembled with a liner while the Reverse glenoid construct consists of the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented.

System		Components	Material	Use
A	R			Cem	Not 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 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

FORM FDA 3881 (8/14)

EF PSC Publishing Services (301) 443-6740

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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.

· In the US the SMR TT Metal Back Glenoid 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.

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)

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Summary of Safety and Effectiveness

Date: April 5th, 2016

Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy

U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant Phone: 260-645-0327 FAX: +39 0432945512

Product	Product Code	Regulation and Classification Name
SMR 3-Pegs Glenoids	KWS	Shoulder joint metal/polymer semi-constrainedcemented prosthesis per 21 CFR 888.3660

Description

The SMR 3-Pegs Glenoids are made from conventional UHMWPE. They are intended for cemented fixation only.

The SMR 3-Pegs Glenoids are designed to articulate with the Limacorporate SMR humeral heads indicated for use in total shoulder replacement.

Intended Use

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). ●

Traditional 510(k) - SMR 3-Pegs Glenoids April 5th, 2016

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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.

The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid construct consists of the metal back, the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented.

System		Components	Material	Use
A	R			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 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 StandardsTi6Al4V (ISO 5832-3 - ASTM F1472) - CoCrMo (ISO 5832-12 - ASTM F1537) – UHMWPE (ISO 5834-2 - ASTM F648) -PoroTi Titanium Coating (ASTM F1580)

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.
Traditional 510(k) - SMR 3-Pegs Glenoids April 5th, 2016

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. 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.
In the US the SMR TT Metal Back Glenoid 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.

Predicate Devices

SMR 3-Pegs Glenoids (Limacorporate, K130642);
SMR Cemented Glenoids (Limacorporate, K100858 / K101263 / K110847 / K111212);
SMR Liners L1 for Metal Back Glenoids (Limacorporate, K113254).

Comparable Features to Predicate Device(s):

The intended use, design, and materials of the SMR 3-Pegs Glenoids are substantially equivalent to the ones of the predicate devices. Design Control Activities have been completed and the results indicated that the subject device is safe and effective.

Non-clinical testing

Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices in:

Static Evaluation of the Glenoid Locking Mechanism in Shear (ASTM F1829);
Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028):
Range of motion (ASTM F1378). ●

Clinical testing

Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of SMR 3-Pegs Glenoids to the predicate devices.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”