The SMR Modular Glenoid is intended for use in total primary or revision shoulder joint replacement with either the SMR Anatomic Shoulder System or the SMR Reverse Shoulder system.

The SMR Anatomic Shoulder System is indicated for 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 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 Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabling 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 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.

Device Description

The SMR Modular Glenoid consists of a metal-back and a liner; when used without cement, bone screws are used for additional fixation. These components are used in total shoulder replacements: the SMR Modular Glenoid metal-backs can be used either in anatomical replacement (when coupled with SMR Modular Glenoid liners) or in reverse replacement (when coupled with previously cleared glenospheres and connectors). The SMR Metal Backed Glenoid and Liner construct, when used as part of a SMR Anatomic Shoulder Replacement is intended for use with bone cement and should be used without bone screws. The SMR Metal Backed Glenoid, Connector and Glenosphere construct, when used as part of a SMR Reverse Shoulder Replacement is intended for uncemented use with the addition of screws for fixation. The size large metal back is not suitable for coupling with 36 mm concentric glenosphere.

Metal-backed glenoids are made from Ti6A14V. The backside surface of the metal-back is plasma spray titanium coated. Four sizes (small, Standard and Large) are available.

Liners are manufactured from UHMWPE. In anatomical replacement, these devices are intended to be coupled with the SMR Modular Glenoid metal-backs and articulate with previously cleared SMR standard or CTA humeral heads. Liners are available in four sizes (small-R, Small, Standard and Large).

The liner articulating surface has a radius of curvature greater than the corresponding humeral head allowing translation in the superior/inferior and anterior/posterior directions. The SMR system has no restriction in regard to the pairing of different sizes of humeral heads and glenoid components. Each humeral head size can be combined with each glenoid size.

Bone screws are manufactured from titanium alloy Ti6AI4V (ASTM F1472 - ISO 5832-3). Bone screws have a diameter of 6.5 mm and are available in lengths from 20 to 40 mm.

AI/ML Overview

Here's an analysis of the provided text regarding the SMR Modular Glenoid, focusing on the acceptance criteria and study details. It's important to note that this document is a 510(k) summary for premarket notification, which typically focuses on demonstrating substantial equivalence to existing devices rather than new proof of safety and effectiveness through extensive clinical trials. Therefore, the information provided often differs from what might be found in a full PMA (Premarket Approval) application for novel devices.

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes non-clinical testing performed to demonstrate that the SMR Modular Glenoid's performance is comparable or superior to the predicate devices and that it can "perform under expected clinical conditions." The implied acceptance criteria are that the device performs equivalently or better than the predicates in the specified mechanical tests.

Table of Acceptance Criteria and Reported Device Performance

Test Type	Stated Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Static Shear Testing	Comparable or superior performance to predicate devices	(Performance demonstrated, details not provided)
Dynamic Testing	Comparable or superior performance to predicate devices	(Performance demonstrated, details not provided)
Plasma Spray Titanium Coating:	Adhesion: Comparable or superior performance to predicate devices	(Performance demonstrated, details not provided)
Plasma Spray Titanium Coating:	Shear: Comparable or superior performance to predicate devices	(Performance demonstrated, details not provided)
Plasma Spray Titanium Coating:	Shear Fatigue: Comparable or superior performance to predicate devices	(Performance demonstrated, details not provided)
Plasma Spray Titanium Coating:	Abrasion: Comparable or superior performance to predicate devices	(Performance demonstrated, details not provided)
Range of Motion Simulation	Ensure device design does not overly limit range of motion	Ensured no excessive limitation of range of motion

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical test conducted. It states that "All mechanical testing was done on worst case components or constructs." This implies multiple samples were tested for each scenario, but quantitative numbers are not provided.
- Data Provenance: The tests are non-clinical (laboratory/mechanical testing), not human subject data. The manufacturer is Limacorporate S.p.A. in Udine, Italy. The testing would have been conducted in a laboratory setting, likely in Italy or a certified testing facility hired by the manufacturer. The data is prospective for these tests, as they were specifically performed for this 510(k) submission.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable as the "test set" refers to mechanical testing of the device, not human data requiring expert ground truth. The "ground truth" here is the physical performance and material properties determined by testing equipment and protocols.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 refer to expert review of medical images or patient outcomes, which is not relevant for mechanical testing.
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 device is a shoulder implant, not an AI-assisted diagnostic tool. No MRMC studies were performed.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical implant, not a software algorithm.
The Type of Ground Truth Used:
- The "ground truth" for the non-clinical tests was established through standardized mechanical engineering tests using established protocols (some referencing "standard test methods" to allow comparison to predicate devices). This involves physical measurements, stress/strain analysis, and material property evaluations.
The Sample Size for the Training Set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
How the Ground Truth for the Training Set was Established:
- Not applicable. As there's no training set for AI, there's no ground truth established in this manner.

Summary of the Study for Substantial Equivalence:

The study conducted for the SMR Modular Glenoid was a non-clinical bench testing program. The primary goal was to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This was achieved by:

Design and Material Comparison: Highlighting similarities in intended use, indications, design (minor modifications like lugs for versatility), and materials (Ti6A14V, UHMWPE) to the predicate devices.
Mechanical Testing: Performing a series of mechanical tests on the SMR Modular Glenoid, including:
- Static Shear Testing
- Dynamic Testing
- Plasma Spray Titanium Coating tests (Adhesion, Shear, Shear Fatigue, Abrasion)
- Range of Motion simulation
Worst-Case Scenarios: Conducting mechanical tests on "worst case components or constructs" to ensure robustness.
Standard Test Methods: Utilizing standard test methods where possible to facilitate comparison with predicate device testing.
Conclusion: The testing results "demonstrated the device's ability to perform under expected clinical conditions," implicitly indicating that its performance was comparable or superior to the predicate devices, thereby supporting the claim of substantial equivalence.

Clinical Testing: The document explicitly states: "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Modular Glenoid to the predicate devices." This is common for 510(k) submissions where sufficient non-clinical data and comparison to predicates can establish equivalence.

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 stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird-like figure.

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

November 2, 2016

Limacorporate S.p.A. % Ms. Cheryl Hastings Hastings Regulatory Consulting, LLC P.O. Box 696 Winona Lake, Indiana 46590-696

Re: K113254 Trade/Device Name: SMR Modular Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: February 21, 2012 Received: February 22, 2012

Dear Ms. Hastings:

This letter corrects our substantially equivalent letter of February 24, 2012.

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 Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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,

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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510(k) Number (if known): Unknown Device Name: SMR Modular Glenoid Indications for Use:

SMR Modular Glenoid Indications for Use

< 113254

The SMR Modular Glenoid is intended for use in total primary or revision shoulder joint replacement with either the SMR Anatomic Shoulder System or the SMR Reverse Shoulder svstem.

The SMR Anatomic Shoulder System is indicated for 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 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.

Scieed migrants and a rantenoid Connector/Glenosphere construct, used as part of the SMR The Britis Mean Datable cent, is intended for uncemented use with the addition of screws for fixation.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Millerm

(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic, DIVision of Bovices

Page 1 of 1

Traditional 510(k) - K113254 SMR Modular Glenoid

510(k) Number 2

Company Confidential

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FEB 2 4 2012

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Summary of Safety and Effectiveness

Date: October 27, 2011

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

U.S. Contact Person: Cheryl Hastings Principal Consultant Phone: 574-527-4220

Product	SMR Modular Glenoid
Product Code	KWS
Regulation and Classification Name	Shoulder joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3660

Description:

Metal-backed glenoids are made from Ti6A14V. The backside surface of the metal-back is plasma spray titanium coated. Four sizes (small, Standard and Large) are available.

Traditional 510(k) - K 113254 SMR Modular Glenoid

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K113254

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Bone screws are manufactured from titanium alloy Ti6AI4V (ASTM F1472 - ISO 5832-3). Bone screws have a diameter of 6.5 mm and are available in lengths from 20 to 40 mm.

Intended Use:

The SMR Modular Glenoid is intended for use in total primary or revision shoulder joint replacement with either the SMR Anatomic Shoulder System or the SMR Reverse Shoulder system.

The SMR Anatomic Shoulder System is indicated for 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 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.

Predicate Devices:

SMR Reverse Shoulder System metal-back glenoid (Limacorporate, K110598);

SMR Shoulder System (Limacorporate, K100858);

SMR Uncemented Shoulder System (Limacorporate, K101263);

SMR CTA Humeral Heads (Limacorporate, K110847);

SMR Revision Stems (Limacorporate, K111212);

Bio-modular Shoulder System (Biomet, K030710, K992119);

Metal-backed Revision Glenoid (Encore - DJO, K081448).

Comparable Features to Predicate Device(s): The SMR Modular Glenoid is similar to the predicate devices in terms of intended use, indications, design and materials. The

Traditional 510(k) - K 113254 SMR Modular Glenoid

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K113254

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SMR Modular Glenoid and the predicates are all intended for total primary or revision shoulder joint replacement. The metal-backs are plasma spray coated. Fixation methods for the SMR Modular Glenoid depend on whether it is being used with an Anatomic or Reverse Shoulder System. These fixation methods are similar to those for the predicate Anatomic and Reverse Shoulder Systems. ·

The metal-back glenoid of the SMR Modular Glenoid system has a design which is similar to the metal-back glenoid used for the SMR Reverse Shoulder System (K110598): the only difference is the addition of four lugs to allow the same metal back glenoid to be used with either the SMR Anatomic Shoulder or with the SMR Reverse Shoulder. Like the Bio-modular Shoulder System (Biomet), the liner-metal back coupling is achieved through a snap-fit junction.

The components of the SMR Modular Glenoid are manufactured from the same or similar materials as the predicate devices.

Non-Clinical Testing: The SMR Modular Glenoid was tested in static shear and dynamic testing. The plasma spray titanium coating was tested in adhesion, shear, shear fatigue and abrasion testing. A Range of Motion simulation has been performed to ensure the device design does not overly limit range of motion. All mechanical testing was done on worst case components or constructs. Where possible, standard test methods were used to allow comparison to testing of the predicate devices. The testing results demonstrated the device's ability to perform under expected clinical conditions.

Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Modular Glenoid 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.”