The SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body - humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The glenoid is intended for cemented use only. Total and hemi-shoulder replacement utilizing the CTA head is indicated for patients suffering from disability due to:

. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
. Inflammatory degenerative joint discase such as rheumatoid arthritis;
. Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
. Cuff tear arthropathy.

Device Description

The SMR CTA Humcral Heads (cleared via 510(k): K110847) are intended for use with a humcral body - humeral stem assembly in total or hemi-shoulder joint arthroplasty. The CTA heads are coupled with the humeral bodies by means of an adaptor taper. When used in total shoulder replacement, the SMR CTA Humeral Heads are coupled with glenoid components.

The SMR CTA Humeral Heads were cleared in K110847 for use with the humeral stems, humeral bodics, adaptor tapers and glenoid components cleared in K100858, K101263 and K113254.

This submission is to modify the labeling for the SMR CTA Humeral Heads to add the SMR Reverse Humeral Bodies, cleared via K110598, as additional compatible components. An adaptor for the reverse humeral body is being added to allow coupling between the SMR CTA Humeral Heads and the SMR Reverse humeral body. When used with the CTA Humeral Heads, the SMR Reverse Humeral Bodies are intended for anatomic shoulder replacement.

AI/ML Overview

Acceptance Criteria and Device Performance Study for SMR CTA Humeral Heads

The provided document describes a 510(k) submission for a modification to the labeling of the SMR CTA Humeral Heads to include SMR Reverse Humeral Bodies as compatible components. This is a special 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device for a minor change, rather than proving primary effectiveness for a novel device. As such, the "acceptance criteria" here refer to demonstrating equivalence in critical physical characteristics, not clinical performance metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Taper Dimensions and Tolerances	The adaptor tapers for coupling the SMR CTA Humeral Heads to the SMR Reverse Humeral Bodies must be equivalent in dimensions and tolerances to: - The taper coupling for the SMR reverse humeral bodies and liners cleared via K110598 (predicate) - The taper coupling for the SMR CTA Humeral Heads and adaptors cleared via K110847 (predicate)	A print review was conducted. The comparisons indicate that the adaptor tapers for the coupling of the reverse humeral bodies and the CTA heads are equivalent in dimensions and tolerances to the predicates.
Fretting / Corrosion Risk	The SMR CTA Humeral Head / SMR Reverse Humeral Body adaptor must not introduce new risks of fretting or corrosion compared to the predicate devices.	A review of previously conducted fretting / corrosion testing was performed. This review indicates that the SMR CTA Humeral Head / SMR Reverse Humeral Body adaptor does not introduce new risks of fretting or corrosion.
Substantial Equivalence	Demonstrating that the modified SMR CTA Humeral Heads (with SMR Reverse Humeral Bodies as compatible components) are substantially equivalent to the predicate devices (SMR CTA Humeral Heads cleared in K110847 and SMR Reverse Shoulder System cleared in K110598) based on similarities in indications, intended use, design, materials, surface finishing, and method of manufacture.	Limacorporate believes that the devices are substantially equivalent based on similarities in indications, intended use, design, materials, surface finishing, method of manufacture, and the conducted print review comparing taper dimensions and tolerances. The FDA concluded that the device is substantially equivalent for the stated indications for use.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the traditional sense of a clinical or retrospective data set. The "test set" consisted of the design specifications (prints) for the new adaptor and the previously cleared components.
Data Provenance: The data provenance is internal to the manufacturer (Limacorporate S.p.A.), based on their design documentation and previous testing records. It is retrospective in the sense that it relies on existing design data and prior test results. The country of origin for the manufacturing and design is Italy.

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

Number of Experts: Not explicitly stated as a separate team of external experts. The "ground truth" for the design specifications and testing results would have been established by the engineering and quality assurance teams at Limacorporate S.p.A. who are responsible for device design, manufacturing, and regulatory compliance.
Qualifications of Experts: Assumed to be qualified engineers and technical personnel with expertise in orthopedic implant design, material science, mechanical testing, and regulatory requirements for medical devices. Specific experience levels are not provided in this summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable in a clinical context. The "adjudication" in this non-clinical submission would be the internal review and approval process by Limacorporate's technical and regulatory teams, followed by FDA's review for substantial equivalence. The print review and review of existing test data constitute the evidence presented for this "adjudication."

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

No MRMC study was done. Clinical testing was explicitly stated as "not necessary to demonstrate substantial equivalence" for this specific modification. This is common for special 510(k)s where changes are minor and do not impact clinical performance.

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

No standalone study was done. This is not an AI or algorithm-based device, but a mechanical orthopedic implant. Therefore, "standalone performance" in the context of an algorithm is not relevant. The performance evaluated was solely on the physical compatibility and predicted mechanical integrity of the component interface.

7. Type of Ground Truth Used

The "ground truth" for this submission was based on engineering specifications and established mechanical testing protocols.
- For taper dimensions and tolerances: ground truth was the validated design prints and specifications for each component.
- For fretting/corrosion risk: ground truth was established by previously conducted and validated fretting/corrosion testing results from the predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical implant, not a software algorithm that requires a "training set" in the machine learning sense. The engineering design and manufacturing processes are developed based on established biomechanical principles and material science, not statistical training data.

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

Not applicable. As a mechanical device, there is no "training set" or "ground truth for a training set" as would be found in AI/ML applications. The design and validation are based on engineering standards, material properties, and mechanical test results.

Summary

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K131112 Page 1 of 2

JUN 0 7 2013

510(k) Summary

Date: May 15, 2013

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 FAX: +39 0432945512

Product	CommonName	ProductCode	Regulation and Classification Name
SMR CTAHumeral Heads	Total orHemiShoulderProsthesis	KWS	Shoulder joint metal/polymer semi-constrainedcemented prosthesis per 21 CFR 888.3660
		HSD	Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesis per 21 CFR 888.3690

Description:

The SMR CTA Humeral Heads were cleared in K110847 for use with the humeral stems, humeral bodics, adaptor tapers and glenoid components cleared in K100858, K101263 and K113254.

Intended Use / Indications:

. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
. Inflammatory degenerative joint discase such as rheumatoid arthritis;
. Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
. Cuff tear arthropathy.

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Predicate Device:

Limacorporate SMR CTA Humeral Heads (K110847) Limacorporate SMR Reverse Shoulder System (K110598)

Summary of Technologies/Substantial Equivalence:

Based on similarities in indications, intended use, design, materials, surface finishing, method of manufacture and a print review to compare taper dimensions and tolerances, Limacorporate believes that the SMR CTA Humeral Heads with modified labeling to include the SMR Reverse Humeral Bodies as compatible components are substantially equivalent to the SMR CTA Humeral Heads cleared in K110847.

Non-Clinical Testing:

A print review was conducted to compare the taper dimensions and tolerances of the adaptor used for coupling the SMR CTA Humeral Heads to the SMR Reverse Humcral Bodies with the taper coupling for the SMR reverse humeral bodies and liners cleared via K110598 and with the taper coupling for the SMR CTA Humeral Heads and adaptors cleared via K110847. These comparisons indicate that the adaptor tapers for the coupling of the reverse humeral bodies and the CTA heads is equivalent in dimensions and tolerances to the predicates. A review of previously conducted fretting / corrosion testing also indicates that the SMR CTA Humeral Head / SMR Reverse Humeral Body adaptor does not introduce new risks of fretting or corrosion.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the SMR CTA Humeral Heads with modified labeling to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 7, 2013

Limacorporate S.p.A. % Ms. Cheryl Hastings Principal Consultant P.O. Box 696 Winona Lake. Indiana 46590-0696

Re: K131112

Trade/Device Name: SMR CTA Humeral Heads Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: May 3, 2013 Received: May 10, 2013

Dear Ms. Hastings:

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

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Page 2 - Ms. Cheryl Hastings

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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers. International and Consumer Assistance 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.

For

Sincerely yours.

Erin.Keith

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

K131112 510(k) Number (if known):

SMR CTA Humeral Heads Indications for Use

. 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;
Cuff tear arthropathy. .

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)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

Page I of 1

Special 510(k) - Device Modification: SMR CTA Humeral Heads March 05, 2013

Page 6 of 144

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.”