The SEVIN Reverse Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

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 humeral component is intended for cemented use and the TPS coated metaglene component is intended for cementless use with the addition of screws for fixation.

Device Description

The SEVIIN Reverse Shoulder is a total shoulder prosthesis designed for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prostheses. The reverse shoulder is designed so that the "ball" of the articulation is on the glenoid side and the mating "cup" fits into the humeral stem. The components of the system include a Ti-6A1-4V alloy metaglene plate with titanium plasma spray coating, Ti-6Al-4V alloy bone screws, a Co-Cr-Mo alloy glenosphere, a Co-Cr-Mo alloy humeral cup and an ultra high molecular weight polyethylene (UHMWPE) inlay. These components are intended for use with the previously cleared SEVIIN humeral stems (cleared as the Genesis humeral stems).

The metaglene plate incorporates a cannulated cancellous central screw with cross holes and 4 peripheral screws for added stability. The screws have a 4.5mm diameter and are available in lengths of 24mm, 33mm and 42mm. The glenosphere mates with the metaglene plate via a taper lock and a glenosphere screw. The glenosphere is available in 36 and 40 mm diameter sizes with standard and +4 mm offsets.

The humeral cup mates with the humeral stem via a taper lock. The humeral cup is available in standard and +9 mm offsets. The proximal side of the humeral cup incorporates a snapfit mechanism and anti-rotation tabs that mate with the poly inlay. The poly inlay is a concave liner that is intended to articulate with the glenosphere proximally and attach to the humeral cup distally. The poly inlay is available in 36 mm diameters, centered and retentive, with 0, +3, and 6 mm offsets.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML or diagnostic performance. Instead, the document is a 510(k) premarket notification for a medical device called the "SEVIIN Reverse Shoulder" (K120374).

The document states:

Clinical Testing: "Clinical testing was not necessary to determine substantial equivalence of the SEVIIN Reverse Shoulder to the predicate devices." This means no clinical study was conducted for this specific device.
Non-Clinical Testing: "Analysis of Range of Motion and testing of glenoid component fixation, assembly fatigue, humeral cup and poly inlay fixation and medical bone screw properties indicate that all components are adequate for their intended use." This refers to biomechanical and material testing rather than a study evaluating diagnostic performance or AI effectiveness.

Therefore, I cannot provide the requested information as it is not present in the given text. The questions about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to the content provided.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

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

November 2, 2016

Ingen Orthopedics, LLC Mr. Perry A. Geremakis President, Chief Executive Officer 2650 U.S. Highway 130 Cranbury, New Jersey 08512

Re: K120374

Trade/Device Name: SEVIN Reverse Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: June 29, 2012 Received: July 3, 2012

Dear Mr. Geremakis:

This letter corrects our substantially equivalent letter of July 9, 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/Resourcesfor You/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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K120374

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: SEVIIN Reverse Shoulder

Indications for Use:

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 humeral component is intended for cemented use and the TPS coated metaglene component is intended for cementless use with the addition of screws for fixation.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

A. S

Page 1 of 1

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

KIZO374 510(k) Number

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K120374

p. 1/3

JUL 9 2012
510(k) Summary
Prepared:	February 4, 2012
Submitter:	Ingen Orthopedics, LLC2650 US Highway 130Cranbury, NJ 08512
Contact:	Perry A. GeremakisPresident, Chief Executive OfficerIngen Orthopedics, LLCP: 609/409-3316F: 609/409-3317E: pgeremakis@ingenortho.com
Proprietary Name:	SEVIIN Reverse Shoulder
Common Name:	Total Shoulder Prosthesis
Classification Names:	21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis; Class II
Product Codes:	KWS
SubstantiallyEquivalent Devices:	Zimmer Anatomical Shoulder Inverse/Reverse TotalShoulder Prosthesis, K053274, cleared January 25, 2006Tornier Aequalis Reversed Shoulder Prosthesis, K041873,cleared August 25, 2004Encore Medical Encore Reverse Shoulder Prosthesis,K041066, cleared March 24, 2005Genesis Medical Genesis Total Shoulder Replacement,K043346, cleared January 31, 2005

Device Description:

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KI20374

components of the system include a Ti-6A1-4V alloy metaglene plate with titanium plasma spray coating, Ti-6Al-4V alloy bone screws, a Co-Cr-Mo alloy glenosphere, a Co-Cr-Mo alloy humeral cup and an ultra high molecular weight polyethylene (UHMWPE) inlay. These components are intended for use with the previously cleared SEVIIN humeral stems (cleared as the Genesis humeral stems).

Intended Use / Indications:

The SEVIIN Reverse Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

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 humeral component is intended for cemented use and the TPS coated metaglene component is intended for cementless use with the addition of screws for fixation.

Summary of Technologies/Substantial Equivalence:

The SEVIIN Reverse Shoulder is substantially equivalent to the predicate devices in regards to its intended use and indications, materials, size ranges, and design intent. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues.

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Non-Clinical Testing:

Analysis of Range of Motion and testing of glenoid component fixation, assembly fatigue, humeral cup and poly inlay fixation and medical bone screw properties indicate that all components are adequate for their intended use.

K120374

Clinical Testing:

Clinical .resting was not necessary to determine substantial equivalence of the SEVIIN Reverse Shoulder to the predicate devices.

9 .

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.”