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.

Device Description

The SMR Shoulder System in Anatomic configuration usually consists of a humeral stem, a humeral body, an adaptor taper, a humeral head and a glenoid component. Components are offered for hemi or total shoulder joint arthroplasty, in primary trauma surgery. SMR Shoulder System components are provided in different designs and are intended for cemented or cementless use.

Humeral stems are connected with humeral bodies trough taper coupling. The humeral body is then coupled with the humeral heads, directly (only for some sizes of the heads) or through adaptor tapers. Adaptor tapers are made of Ti6A14V. They are neutral or with eccentricities and in different offsets to allow the adjustment of the centre of rotation of the joint, to provide the required offset to the humeral head and to achieve the correct balancing to the soft tissues, optimizing joint stability. The humeral heads are made of CoCrMo. They are intended to articulate with the glenoid bone in hemi-arthroplasty or with the glenoid component in total shoulder joint arthroplasty.

The current submission is for the extension of the available heights for each diameter of the humeral heads and for the introduction of a new eccentricity (+6 mm) for the adaptor tapers.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding the "SMR Shoulder System". It's a regulatory approval document for a medical device, specifically shoulder joint prostheses.

Based on the provided text, the device is the "SMR Shoulder System". This document is a "Special 510(k) - Device Modification" focusing on the extension of available heights for humeral heads and the introduction of a new eccentricity (+6 mm) for adaptor tapers for the shoulder system.

The core of the request is to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets acceptance criteria through a new study. Therefore, the information you're asking for regarding acceptance criteria and a study to prove it is largely not present in this document for the specific modifications.

Here's a breakdown of why and what information is available:

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

Acceptance Criteria: Not explicitly stated as pass/fail criteria in this document for the specific modifications. The FDA's acceptance is based on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves showing that the device has the same intended use, similar technological characteristics, and does not raise different questions of safety and effectiveness.
Reported Device Performance: The document states that the new components (Variable-Height Humeral Heads and 6mm Eccentricity Adaptor Tapers) do not represent worst cases for mechanical testing. Therefore, the performance is assumed to be equivalent to the predicate device in terms of mechanical properties.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable / Not provided for the current modification. The submission states "no additional testing was required to demonstrate substantial equivalency" for these modifications. This implies that no new test set was generated or analyzed for these specific changes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable / Not provided. Since no new testing was conducted for these modifications, there's no mention of experts establishing a ground truth for a test set. This type of information would be relevant for studies involving diagnostic accuracy or clinical outcomes, which are not the focus of this particular 510(k) modification.

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

Not applicable / Not provided. No test set for ground truth establishment.

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. This document is for a shoulder prosthesis, not an AI-powered diagnostic tool. Therefore, MRMC studies ("human readers improve with AI") are entirely irrelevant and not mentioned.

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

Not applicable. This device is a physical implant, not an algorithm.

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

Not applicable. For this specific 510(k) modification, the "ground truth" to establishing substantial equivalence relies on the established safety and effectiveness of the predicate device (K100858) and the argument that the changes do not introduce new safety or effectiveness concerns. There isn't a "ground truth" in the sense of clinical outcomes or expert labels being evaluated for the modified device itself in this submission.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. See point 8.

Summary of available information related to "acceptance criteria" and "study" for this specific 510(k) modification:

The "study" performed here is a demonstration of substantial equivalence to a predicate device already on the market (SMR Shoulder System cleared via K100858).

Table of "Acceptance Criteria" and "Reported Device Performance" (as interpreted from the document):

Acceptance Criterion (Implicit for "Substantial Equivalence")	Reported Device "Performance" (for these modifications)
Mechanical Performance: Do new components (Variable-Height Humeral Heads, 6mm Eccentricity Adaptor Tapers) meet established mechanical safety profiles?	"The Variable-Height Humeral Heads and 6mm Eccentricity Adaptor Tapers do not represent worst cases for mechanical testing. Therefore, the results of the tests performed on the SMR Shoulder System in K100858 are applicable to the Variable-Height Humeral Heads and the 6mm Eccentricity Adaptor Tapers and no additional testing was required to demonstrate substantial equivalency." (This indicates "performance" is considered equivalent to the already cleared predicate for mechanical properties.)
Material Composition: Are the materials of the new components consistent with predicate and recognized standards?	"The new heights of the Humeral Heads and the new Adaptor Taper... are identical to the Humeral Heads and Adaptor Tapers cleared via K100858 for design diameters, material, intended use, indications for use." (Materials are listed in tables: Ti6Al4V, CoCrMo, UHMWPE, PoroTi, Titanium Coating, conforming to ISO/ASTM standards).
Intended Use/Indications: Do the new components maintain the same intended use and indications as the predicate?	"The indications for use for the devices submitted are the same of the heads and adaptor tapers of the SMR Shoulder System used in anatomic configuration cleared via previous 510(k)s." (This confirms the intended use and indications match the predicate, fulfilling a key "performance" aspect for substantial equivalence.)

In essence, for this specific 510(k) submission, the "study" demonstrating the device meets "acceptance criteria" is a determination by the manufacturer (and accepted by the FDA) that the modified components are substantially equivalent to a previously cleared device (K100858) through a comparison of technological characteristics and a rationale for why new mechanical or clinical testing is not necessary due to the nature of the modification.

Summary

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

June 24, 2016

Limacorporate S.p.A. % Dr. Stephen J. Peoples President Peoples & Associates 411 Auditorium Blvd. Winona Lake, Indiana 46590

Re: K161476

Trade/Device Name: SMR Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT. HSD Dated: May 20, 2016 Received: May 27, 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 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/Resourcesfor You/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,

Lori A. Wiggins -S

for

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K161476

SMR Shoulder System Indications for Use

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). ●

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient ioint 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.

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 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	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

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System		Components	Material	Use
A	R			Cem	Not Cem
●		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 Standards
Ti6Al4V (ISO 5832-3 - ASTM F1472) - CoCrMo (ISO 5832-12 - ASTM F1537) – UHMWPE (ISO 5834-2 - ASTM F648) - PoroTi
Titanium Coating (ASTM F1580)

*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.
· The SMR TT Metal Back is indicated for primary implant in anatomic or reverse total shoulder arthroplasty with poor glenoid bone quality or in revision case with consistent bone loss on the glenoid side. The implant is suitable for implantation with or without bone graft. These indications are not yet approved in the US.
. 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.
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 o Adaptor Tapers (both concentric and eccentric)

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON ANOTHER PAGE IF NEEDED

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510(k) Summary

Date: May 20, 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	ProductCode	Regulation and Classification Name
SMR Shoulder System-Variable HeightHumeral Heads	HSD	Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesis per 21 CFR 888.3690
-6mm eccentricityadaptor tapers	KWT	Shoulder joint metal/polymer non-constrained cementedprosthesis per 21 CFR 888.3650

Description

The current submission is for the extension of the available heights for each diameter of the humeral heads and for the introduction of a new eccentricity (+6 mm) for the adaptor tapers.

Intended Use/Indications

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

Special 510(k) - Device Modification: SMR Shoulder System May 4, 2016

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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 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.

System				Use
A	R	Components	Material	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*

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System				Use
ব	R	Components	Material	Cem	Not Cem
. *		SMR Bone screws	Ti6Al4V		X
Material Standards
Ti6A4V (ISO 5832-3 - ASTM F1472) - CoCrMo (ISO 5832-12 - ASTM F1537) - UHMWPE (ISO 5834-2 - ASTM F648) - PoroTi
Titanium Coating (ASTM F1580)

*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.
The SMR TT Metal Back is indicated for primary implant in anatomic or reverse total shoulder arthroplasty with poor glenoid bone quality or in revision case with consistent bone loss on the glenoid side. The implant is suitable for implantation with or without bone graft. These indications are not yet approved in the US.
· 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.
· 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).

Predicate Devices

SMR Shoulder System (Limacorporate, K100858).

Comparable Features to Predicate Device(s)

The new heights of the Humeral Heads and the new Adaptor Taper of the SMR Shoulder System are identical to the Humeral Heads and Adaptor Tapers cleared via K100858 for design diameters, material, intended use, indications for use.

The indications for use for the devices submitted are the same of the heads and adaptor tapers of the SMR Shoulder System used in anatomic configuration cleared via previous 510(k)s. The combinations allowed for the new heights of the Humeral Heads and the new Adaptor Tapers of the SMR Shoulder System are identical to those allowed with Humeral Heads and Adaptor Tapers already cleared via K100858.

Non-Clinical Testing:

The Variable-Height Humeral Heads and 6mm Eccentricity Adaptor Tapers do not represent worst cases for mechanical testing. Therefore, the results of the tests performed on the SMR Shoulder System in K100858 are applicable to the Variable-Height Humeral Heads and the 6mm Eccentricity Adaptor Tapers and no additional testing was required to demonstrate substantial equivalency of the Variable-Height Humeral Heads and additional adaptor tapers.

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Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Variable-Height Humeral Heads and the 6 mm Eccnetricity Adaptor Tapers to the humeral heads and adaptor tapers cleared for the SMR Shoulder System in K100858.

Special 510(k) – Device Modification: SMR Shoulder System May 4, 2016

Regulation Number and Section

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”