The SMR TT Metal Back 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):

When used as part of the SMR Anatomic Shoulder System, the SMR TT Metal Back Glenoid is intended for use with bone cement and should be used without bone screw.

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. When used as part of the SMR Reverse Shoulder System, the SMR TT Metal Back Glenoid is intended for uncemented use with the addition of screws for fixation.

Device Description

SMR TT Metal Back device described in this submission is identical to the device described in K133349. This submission includes an alternative surgical technique and surgical instruments to be used in combination with SMR TT Metal Back device, instruments and surgical technique described in K133349 in Reverse SMR Shoulder System configuration.

AI/ML Overview

This FDA 510(k) premarket notification (K161120) for the SMR TT Metal Back Glenoid and Bone Graft Instruments does not describe a study that involves an AI/ML device. Therefore, the requested information cannot be extracted from this document.

The document is a submission for a shoulder joint prosthesis and associated instruments. It seeks to establish substantial equivalence to a previously cleared predicate device (K133349) by Limacorporate S.p.A. The key aspect of this submission revolves around an alternative surgical technique and surgical instruments for the existing SMR TT Metal Back device, particularly for use in the SMR Reverse Shoulder System.

It explicitly states on Page 5:

"Non-clinical testing was not necessary to support the equivalence of the subject SMR TT Metal Back Glenoid to the device cleared in K133349."
"LAL testing has been performed to establish the non-pyrogenicity of Limacorporate products."
"Clinical testing was not necessary to support the equivalence of the SMR TT Metal Back Glenoid to the device cleared in K133349."

Since no studies related to AI/ML performance were conducted or are reported in this document, it is not possible to provide acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information for an AI/ML device.

Summary

{0}------------------------------------------------

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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

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

February 21, 2017

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

Re: K161120

Trade/Device Name: SMR TT Metal Back Glenoid, Bone Graft Instruments Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWS, KWT Dated: January 12, 2017 Received: January 17, 2017

Dear Stephen 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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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" (21 CFR 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

{2}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161120

Device Name

SMR TT Metal Back Glenoid, Bone Graft Instruments

Indications for Use (Describe)

The SMR TT Metal Back 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);

When used as part of the SMR Anatomic Shoulder System, the SMR TT Metal Back Glenoid is intended for use with bone cement and should be used without bone screws.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PSC Publishing Services (301) 443-6740

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Summary of Safety and Effectiveness

Date: January 25, 2017

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	CommonName	ProductCode	Regulation and Classification Name
SMR TT MetalBack Glenoid,Bone GraftInstruments	Total orHemiShoulderProsthesis	KWS	Shoulder joint metal/polymer semi-constrained cemented prosthesis per CFR888.3660
		KWT	Shoulder joint metal/polymer non-constrained cemented prosthesis per CFR888.3650
		PHX	Shoulder joint metal/polymer semi-constrained cemented prosthesis per CFR888.3660

Description

Intended Use

The SMR TT Metal Back 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;

Traditional 510(k) - SMR TT Metal Back Glenoid

{4}------------------------------------------------

· Revision of a failed primary implant;
· Cuff tear arthropathy (CTA Heads):

When used as part of the SMR Anatomic Shoulder System, the SMR TT Metal Back Glenoid is intended for use with bone cement and should be used without bone screw.

Predicate Device

SMR TT Metal Back Glenoid (K133349).

Comparable Features to Predicate Device(s)

SMR TT Metal Back device described in this submission is identical to the device described in K133349. This submission includes an alternative surgical technique and surgical instruments to be used in combination with SMR TT Metal Back device in SMR Reverse configuration, instruments and surgical technique described in K133349.

Non-Clinical Testing

Non-clinical testing was not necessary to support the equivalence of the subject SMR TT Metal Back Glenoid to the device cleared in K133349.

LAL testing has been performed to establish the non-pyrogenicity of Limacorporate products.

Clinical Testing

Clinical testing was not necessary to support the equivalence of the SMR TT Metal Back Glenoid to the device cleared in K133349.

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.”