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.

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 Reverse Shoulder System humeral bodies, cemented non-finned humeral stems and cemented revision stems are intended for cemented use. The SMR Reverse Shoulder System humeral bodies, finned humeral stems and uncemented revision stems are intended for cementless use. The SMR Reverse Shoulder System metal-backed glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation.

Device Description

The SMR Reverse Shoulder System (cleared via 510(k): K110598) consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenosphere and a connector with screw. Bone screws are used for the fixation of the metal-back glenoid to the scapula. Humeral stems and reverse humeral bodies are provided for both cementless fixation. The SMR Reverse Shoulder System metal back glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation.

This submission is to add the SMR Revision Stems, cleared in K111212, as compatible humeral stem components of the SMR Reverse Shoulder System.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the SMR Reverse Shoulder System. It is concerned with demonstrating substantial equivalence to a predicate device, rather than presenting a study of device performance against specific acceptance criteria. Therefore, most of the information requested in your prompt is not available in this document.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:
Not applicable. This document is not a clinical study or a performance validation report against specific acceptance criteria. Its purpose is to demonstrate "substantial equivalence" of a modified device to a previously cleared predicate device.

2. Sample size used for the test set and the data provenance:
Not applicable. No "test set" in the context of device performance testing is mentioned. The submission relies on a "print review" and comparison of taper dimensions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts is described for performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method is described.

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 device is a shoulder implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. For the purpose of this 510(k) submission, the "ground truth" equivalent would be the existing characteristics and performance of the predicate device, against which the modified device is compared to establish equivalence.

8. The sample size for the training set:
Not applicable. No training set is mentioned as this device is not an AI/ML algorithm.

9. How the ground truth for the training set was established:
Not applicable. No training set is mentioned.

Summary of available information related to "acceptance criteria" and "study":

The "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a predicate device.

Predicate Device: Limacorporate SMR Reverse Shoulder System (K110598)
"Study" conducted: A non-clinical "print review" was performed.
- This review compared the taper dimensions and tolerances of the SMR Revision Stems (the modification) to the taper dimensions and tolerances of the SMR humeral stems cleared for use with the predicate device.
- Conclusion: The comparison indicated that the SMR Revision Stem tapers were substantially equivalent to the SMR Humeral Stem tapers.
Clinical Testing: The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Reverse Shoulder System with modified labeling to the predicate device."

In essence, for this specific 510(k) submission, the "acceptance criteria" were met by a successful non-clinical engineering comparison demonstrating that the modification (addition of SMR Revision Stems) maintained the equivalence in design and dimensions to previously cleared components within the existing system.

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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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 LLC P.O. Box 696 Winona Lake, Indiana 46590-696

Re: K113523

Trade/Device Name: SMR Reverse Shoulder System 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: November 22, 2011 Received: November 29, 2011

Dear Ms. Hastings:

This letter corrects our substantially equivalent letter of December 20, 2011.

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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Indications for Use Statement

510(k) Number (if known): K113523

SMR Reverse Shoulder System Indications for Use

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.

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.

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)

Es Mark. Milhenson

(Division Sign-C (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113523

Special 510(k) - Device Modification: SMR Reverse Shoulder System November 21, 2011

Company Confidential Page 7

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KI13523

510(k) Summary

Date: November 21, 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	Product Code	Regulation and Classification Name
SMR Reverse ShoulderSystem	KWS	Shoulder joint metal/polymer semi-constrainedcemented prosthesis per 21 CFR 888.3660

Description:

This submission is to add the SMR Revision Stems, cleared in K111212, as compatible humeral stem components of the SMR Reverse Shoulder System.

Intended Use / Indications:

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.

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.

Special 510(k) - Device Modification: SMR Reverse Shoulder System November 21, 2011

Page 1 of 2

Page 5

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KII3523

Predicate Device:

Limacorporate SMR Reverse Shoulder System (K110598)

Summary of Technologies/Substantial Equivalence:

Based on similarities in indications, intended use, design, materials, method of manufacture and a print review to compare taper dimensions and tolerances, Limacorporate believes that the SMR Reverse Shoulder with modified labeling to include the SMR Revision Stems as compatible components is substantially equivalent to the SMR Reverse Shoulder System cleared in K110598.

Non-Clinical Testing:

A print review was conducted to compare the taper dimensions and tolerances of the SMR Revision Stems to the taper dimensions and tolerances of the SMR humeral stems cleared for use with the SMR Reverse Shoulder System in K110598. This comparison indicated that the SMR Revision Stem tapers were substantially equivalent to the SMR Humeral Stem tapers.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Reverse Shoulder System with modified labeling to the predicate device.

Special 510(k) - Device Modification: SMR Reverse Shoulder System November 21, 2011

Page 2 of 2

Page 6

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.”