The Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Device Description

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the dettoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional. Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition And to reduce or eliminate pain. The Aegualis Reversed Shoulder Prosthesis is intended to accomplish these goals. Is reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification submission consists in the following changes:

1ª change: addition of components in order to have the possibility to use multidirectional screws with the glenoid baseplate

2 types of components are added to the components of the Aequalis Reversed Shoulder prosthesis:

Multidirectional screws in various length, l
Specific glenoid baseplate for multidirectional screws.
244 change: addition of "fish-scales" on the peg of the humeral insert
314 change: modification of packaging of polyethylene components

The indications for use already covered by the previous 510(k) clearance are not modified.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "AEQUALIS Reversed Shoulder Prosthesis". This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria and device performance evaluation in the typical sense of a clinical trial or performance study for a new, novel device.

Therefore, the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available within this type of regulatory submission.

Here's why and what information is present:

510(k) Premarket Notification: This is a regulatory pathway used to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The primary goal is to show that the device has the same intended use and the same technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
Focus on Equivalence: The document lists the predicate devices (K030941, K041873, K952928, K991585, K021478) and outlines modifications to an already cleared device (addition of multidirectional screws, "fish-scales" on the humeral insert peg, and packaging modifications). The safety and effectiveness are largely inferred from the predicate devices and the nature of the minor modifications.
Lack of Performance Study Details: A 510(k) submission typically does not include extensive clinical studies or performance data comparing the device against specific acceptance criteria for efficacy or diagnostic performance, especially for modifications to an existing, cleared device like this one. Such studies are more common for novel devices or those requiring a PMA (Premarket Approval).

Information that CAN be extracted:

Device Name: AEQUALIS Reversed Shoulder Prosthesis
Regulatory Pathway: Special 510(k)
Indications for Use: For patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with massive and non-repairable rotator cuff-tear, and for prosthetic revisions with massive and non-repairable rotator cuff-tear.
Device Description (Changes):
- Addition of components for multidirectional screws with the glenoid baseplate.
- Addition of "fish-scales" on the peg of the humeral insert.
- Modification of polyethylene component packaging.
Materials: UHMWPE, Titanium alloy.

Conclusion:

Based on the provided document, which is a 510(k) Summary of Safety and Effectiveness for a medical device (specifically an orthopedic implant modification), the requested information regarding acceptance criteria, specific performance studies, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies is not present. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than presenting de novo clinical or performance study data against defined acceptance criteria.

Summary

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MAR 16 2005

TORNIER

Implants Chirurgicaux

Summary of Safety and Effectiveness information
Special 510(k) – AEQUALIS Reversed Shoulder Prosthesis

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

1) Device name
Trade name:	AEQUALIS Reversed Shoulder Prosthesis
Common name:	Total-Shoulder System and Hemi-Shoulder System
Classification name:	Shoulder joint metal/polymer semi-constrained cemented prosthesis

2) Submitter

Tomier S.A. B.P. 11 - Ruc Doyen Gosse 38330 Saint Ismier - France

3) Company contact

Tomier S.A. Mrs Mireille Lémery Regulatory affairs & Quality Engineer ZIRST - 161, rue Lavoisier 38330 Montbonnot - France Tel: 00 33 4 76 61 38 98 Fax: 00 33 4 76 61 35 33 e-mail : mireille.lemery@tomier.fr

Classification Device class: Class II Classification panel: Orthopedic KWS Product code: 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873 Acqualis Shoulder System, TORNIER SA, K952928 Bipolar Shoulder Prosthesis, BIOMET Inc, K991585 Delta Shoulder, DePuy Inc. K021478

6) Device description

Page 1/ page 2

Image /page/0/Picture/14 description: The image shows a logo inside of a hexagon. The logo appears to be the letter 'T' with some additional design elements. The 'T' is stylized with a textured pattern, and there are additional lines and shapes surrounding it, all within the hexagon's border. The image is in black and white.

TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

S.A. au capital de 1 800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B

SIEGE SOCIAL : B.P. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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Implants Chirurgicaux

Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition And to reduce or eliminate pain. The Aegualis Reversed Shoulder Prosthesis is intended to accomplish these goals. Is reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification submission consists in the following changes:

1ª change: addition of components in order to have the possibility to use multidirectional screws with the glenoid baseplate

2 types of components are added to the components of the Aequalis Reversed Shoulder prosthesis:

Multidirectional screws in various length, l
Specific glenoid baseplate for multidirectional screws.
244 change: addition of "fish-scales" on the peg of the humeral insert
314 change: modification of packaging of polyethylene components

The indications for use already covered by the previous 510(k) clearance are not modified.

7) Materials

Metaphyseal inserts are made of ultra high molecular weight polyethylene (UIMWPE) according to ISO standard 5834-2. The base of the glenoid implant is manufactured from Titanium alloy according to ISO standard 5832-3 and the anchoring screws are manufactured from Titanium alloy according to ISO standard 5832-3.

8) Indications

The Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid musche as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when gleaoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemiprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Page 2/ page 2

Image /page/1/Picture/18 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and appears to be constructed from thick, slightly irregular lines, giving it a textured or hand-drawn feel. The hexagon provides a clear, geometric border around the letter, making the logo distinct and easily recognizable.

TORNIER S.A 16), rue Lavoisier 38330 MONTBONNOT FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

S.A. au capital de 1 800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B

STEGE SOCIAL : B.P. 11 - rue du Doycn Gosse - 3830 SAINT-ISMIER - FRANCE

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Image /page/2/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" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine, but in this case, it is a more abstract representation.

Public Health Service

MAR 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mrs. Mireille Lémery Regulatory Affairs and Quality Engineer Tornier S.A. 161 rue Lavoisier 38330 Montbonnot France

Re: K050316

Trade/Device Name: Aequalis Reversed Shoulder Prosthesis Regulation Number: 888.3660 Regulation Name: shoulder joint metal / polymer scmi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: February 4, 2005 Received: February 14, 2005

Dear Mrs. Lemery:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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); 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.

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Page 2 - Mrs. Mireille Lémery

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to begin maneting of substantial equivalence of your device to a legally premits that notification. The PDA mainly of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you ucate specific advice io. Jour 240) 276-0210. Also, please note the regulation entitled, comaci the Office of Comphalled as (21 millication" (21CFR Part 807.97). You may obtain of Small other general information on your respense at its toll-free number (800) 638-2041 or Manufacturers, Internet and Consantip://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

L. Mark N. Mikkelsen

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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:11 koso316

Indications for Use

510(k) Number (if known):

Device Name: Aequalis Reversed Shoulder Prosthesis

Indications For Use:

Prescription Use × (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 CDRA, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K050316

Page 1 of 1

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.”