AEQUALIS REVERSED SHOULDER PROSTHESIS

K041873 · Tornier · PHX · Aug 25, 2004 · Orthopedic

Device Facts

• Record ID: K041873
• Device Name: AEQUALIS REVERSED SHOULDER PROSTHESIS
• Applicant: Tornier
• Product Code: PHX · Orthopedic
• Decision Date: Aug 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The Aequalis Reversed Shoulder Prosthesis humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation. When during the primary surgery the glenoid 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 Reversed prosthesis in to a non reversed hemi-prosthesis. When, in case of revision of a Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Reversed prosthesis in to an anatomical non reversed hemiprosthesis in order to avoid the revision of the humeral components.

Device Story

Aequalis Reversed Shoulder Prosthesis is a semi-constrained shoulder joint system; consists of humeral and glenoid components. Modification adds hemi-prosthesis adaptors (36mm, 42mm) and metaphysis union screw to allow intraoperative conversion of reversed prosthesis to non-reversed hemi-prosthesis if glenoid bone stock is insufficient or fracture occurs. Used by orthopedic surgeons in clinical settings. Device medializes center of rotation to lengthen deltoid muscle lever arm; restores joint function; reduces pain. Benefits include avoiding revision of humeral components during primary surgery or revision procedures when glenoid fixation is compromised.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Semi-constrained shoulder prosthesis. Hemi-prosthesis adaptor and union screw manufactured from Chromium Cobalt alloy per ISO 5832-7 or ISO 5832-12. Humeral component: cemented. Glenoid component: non-cemented with 4-screw fixation.

Indications for Use

Indicated for patients with functional deltoid muscle requiring total shoulder replacement for pain relief and disability due to arthropathy associated with massive, non-repairable rotator cuff tears, or for prosthetic revisions involving such tears.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Aequalis Reversed Shoulder Prosthesis (K030941)
• Aequalis Shoulder System (K952928)
• Bipolar Shoulder Prosthesis (K991585)
• Delta Shoulder (K021478)

Submission Summary (Full Text)

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AUG 2 5 2004

ORNIER

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

Implants Chirurgicaux

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

| 1) Device name | |
|----------------------|-------------------------------------------------------------------|
| Trade name: | <i>AEQUALIS</i> 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 - Rue Doyen Gosse 38330 Saint Ismier - France

#### 3) Company contact

Tornier S.A. Mrs Mireille Lémery Regulatory affairs & Quality Engineer ZIRST - 161, ruc Lavoisier 38330 Montbonnot - France Tel: [phone] Fax: [phone] e-mail : [e-mail]

4) Classification Class II Device class: Classification panel: Orthopedic Product code: KWS \$ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

5) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941 Acqualis Shoulder System, TORNIER SA, K952928 Bipolar Shoulder Prosthesis, BIOMET Inc, K991585 Delta Shoulder, DePuy Inc, K.021478

#### 6) 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 pinor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.

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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

Tornier S.A. 161, ruc Lavoisier 38330 MONTBONNOT FRANCE

Tél. : [phone] Fax : [phone]

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

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K041873
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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 Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to mcdialize 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 addition of components to the Aequalis Reversed Soulder prosibesis in order to have the possibility to transform the Aequalis Reversed Soulder Prosthesis in a standard hemi or total prosthesis in some clinical cases encountered during the surgical procedure.

The present Device Modification submission corresponds to the addition of 3 components of the Aequalis Reversed Shoulder prosthesis:

- Hemi-prosthesis adaptor diameter 36 mm, -
- Hemi-prosthesis adaptor diameter 42 mm, -
- Adaptor metaphysis union screw. ﯩﺖ

with the same indications for use already covered by the previous 510(k) clearance.

#### 7) Materials

The hemi-prosthesis adaptor and the adaptor methaphysis union screw are made of Chromium Cobalt alloy according to ISO standards 5832-7 or ISO 5832-12.

#### 8) Indications

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 non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear.

The Aequalis Reversed Shoulder Prosthesis humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation.

When during the primary surgery the gleaoid 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 Reversed prosthesis in to a non reversed hemi-prosthesis.

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

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Image /page/1/Picture/18 description: The image shows a black and white drawing of a logo. The logo is inside of a hexagon. The logo appears to be a stylized image of a ship.

TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE

Tól. : 33 (0)4 76 61 35 00 Fax : [phone]

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 - 3330 SAINT-ISMITER - FRANCE

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2004

Ms. Mireille Lemery Regulatory Affairs and Quality Engineer Tornier S.A. Zirst -161, rue Lavoisier 38330 Montbonnot, France

Re: K041873

Trade/Device Name: Aequalis Reversed Shoulder Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: July 9, 2004 Received: July 13, 2004

Dear Ms. 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 - Ms. Mireille Lemery

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark A. Milbersen

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

# 510(k) Number (if known): K04187 3

Device Name: Aequalis Reversed Shoulder Frosthesis

#### Indications For Use:

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 non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear.

The Aequalis Reversed Shoulder Prosities humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation.

When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glonoid 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 Reversed prosthesis in to a non reversed hemi-prosthesis.

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

Prescription Use V (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)

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

510(k) Number K041873

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