AEQUALIS REVERSED SHOULDER PROSTHESIS

K030941 · Tornier · PHX · May 14, 2004 · Orthopedic

Device Facts

• Record ID: K030941
• Device Name: AEQUALIS REVERSED SHOULDER PROSTHESIS
• Applicant: Tornier
• Product Code: PHX · Orthopedic
• Decision Date: May 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aegualis 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 Aegualis 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.

Device Story

Semi-constrained total shoulder prosthesis; reversed design medializes center of rotation to lengthen deltoid lever arm. Humeral component: interchangeable stems, metaphysis, and UHMWPE inserts; cobalt-chrome stems/metaphysis; cemented fixation. Glenoid component: titanium alloy base with cobalt-chrome sphere; non-cemented fixation via 4 compression screws. Used in orthopedic surgery to restore joint function and reduce pain in patients with non-repairable rotator cuff-tear arthropathy. Surgeon-operated; implanted in clinical/OR setting. Provides mechanical joint replacement; restores shoulder mobility by utilizing functional deltoid and subscapularis muscles.

Clinical Evidence

Bench testing only. Compliance with ISO 5834-2 (UHMWPE), ISO 5832-3 (Ti alloy), ISO 5832-4/7/12 (CoCr), and ASTM F 1378-97 (Shoulder Prosthesis). Sterilization validated via gamma radiation per ISO 10993.

Technological Characteristics

Semi-constrained shoulder prosthesis. Materials: CoCr (ISO 5832-4, 5832-7, 5832-12), Ti alloy (ISO 5832-3), UHMWPE (ISO 5834-2). Humeral component: cemented stem, metaphyseal parts, inserts. Glenoid component: Ti base, CoCr sphere, 4-screw fixation. Sterilization: gamma radiation.

Indications for Use

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

• BIPOLAR SHOULDER PROSTHESIS, Biomet (K991585)
• Delta 3 Reversed Shoulder Prosthesis, DePuy (K021478)
• AEQUALIS Shoulder System, Tornier (K952928)

Submission Summary (Full Text)

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

Tornier S.A., FRANCE Acqualis Reversed Shoulder Prosthesis

510(k) SUMMARY:

510(k) Number - K430941 Section "1" Supplement B rev 2 March 13, 2004

# MAY 1 4 2004

### 1.0 Device Name:

Trade name: Aequalis Reversed Shoulder Prosthesis Total shoulder prosthesis Common name: Classification name: Shoulder joint, metal/polymer semi-constrained cemented prosthesis Device class: Class II Classification panel: Orthopedic Product code: 87KWS

#### 2.0 Sponsor:

Tornier S.A. Mrs Mireille Lemery Regulatory affairs and Quality Manager B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier France Tel: [phone] Fax: [phone] e-mail : [e-mail]

### 3.0 Submitted by / Company contact:

Donald F. Grabarz Managing Director International Regulatory Consultants, L.C. 7651 S. 700 West, Suite 105 Salt Lake City, Utah 84047 Tel: [phone] Fax: [phone] e-mail : [e-mail]

### 4.0 Equivalent / Predicate device:

BIPOLAR SHOULDER PROSTHESIS, Biomet (K991585), Delta 3 Reversed Shoulder Prosthesis, DePuy (K021478) AEQUALIS Shoulder System, Tornier (K952928)

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

030941

Tornier S.A., FRANCE Aequalis Reversed Shoulder Prosthesis

### 5.0 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, infraspinatus, teres minor 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. 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 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 humeral component:

The humeral part is made of 3 parts consisting of interchangeable stems, metaphysis , and inserts, that may be assembled in different configurations thus accommodating a large variation in patient size and anatomy.

The metaphyseal parts are fixed to the stem by a screwing fixation secured by a polyethylene breaking system. A lateralization spacer can be added to the humeral metaphysis in order to vary the lateralization.

The inserts are impacted on to the conic shape of the metaphysis. A polyethylene peg guides it in the correct position.

The stems are made of cobalt-chrome in 4 diameters The metaphyseal parts are manufactured from cobalt-chrome, in 2 sizes. The inserts are available in polyethylene in 6 sizes. The lateralization spacers are made of cobalt-chrome and are available in 2 sizes.

### The glenoid component:

The glenoid part is composed of a base made of titanium alloy, on which is impacted a sphere of chrome cobalt. The assembly is secured by a central and internal screw. The sphere is available in two diameters congruent with the humeral insert.

The metallic base of the glenoid is fixed to the bone by using 4 compression screws for fixation.

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

$$
\uparrow \star \uparrow \bullet \downarrow \star \downarrow
$$

Tornier S.A., FRANCE Aequalis Reversed Shoulder Prosthesis

510(k) Number - K030941 Section "1" Supplement B rev 3 April 22, 2004 (page 3 only)

### 6.0 Materials:

The material used in the composition of the Aequalis Reversed Shoulder Prosthesis implants is marked on the packaging. Humeral stems are manufactured from Chromium Cobalt alloy (CoCr) according to ISO standard 5832-7 or ISO 5832-12. Humeral metaphysis components are made of Chromium Cobalt alloy (CoCr) according to ISO standard 5832-4. Metaphyseal inserts are made of ultra high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2. The lateralization spacers are made of Chromium Cobalt alloy according to ISO standards 5832-7 and 5832-12. 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. The glenoid sphere from Chromium Cobalt alloy (CoCr) according to ISO standards 5832-7 or 5832-12 and the associated securing mechanism is made of Chromium Cobalt according to ISO standards 5832-7 or 5832-12 and Titanium alloy according to ISO standard 5832-3.

### 7.0 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.

### Standards / Testing: 8.0

All components and parts are biocompatible and comply with the appropriate standards and performance testing for safety and effectiveness in accordance with:

- ISO 5834-2:1998: Implants for Surgery-Ultra-high Molecular Weight Polyethylene-Part 2: l . Moulded Forms;
- ISO standard 5832-3: Implants for Surgery-Metallic Materials Titanium alloy Part 3; 2. Titanium alloy;
- ISO 5832-4:1996: Implants for Surgery-Metallic Materials- Part 4: Cobalt-Chromium-3. Molybdenum Casting Alloy;
- ISO 5832-7:1996: Implants for Surgery-Metallic Materials- Part 7: Cobalt-Chromium-4. Molybdenum Casting Alloy;
- ISO 5832-12:1996: Implants for Surgery-Mctallic Materials- Part 12: Wrought Cobalt-న్. Chromium-Molybdenum Alloy; and,
- American Society for Testing and Materials: F 1378-97 Standard Specification for Shoulder 6. Prosthesis.

Sterilization is accomplished by gamma radiation and the process has been validated and complies with all appropriate standards including ISO 10993

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

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2004

TORNIER S.A. C/o Mr. Donald F. Grabarz Managing Director International Regulatory Consultants, L.C. Mid Valley Professional Plaza 7651 S. 700 West, Suite 105 Salt Lake City, Utah 84047

Re: K030941

Trade 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: March 15, 2004 Received: March 17, 2004

Dear Mr. Grabarz:

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 cnactment 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Mr. Donald F. Grabarz

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 yours,
Mark N. Milliron

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

{5}------------------------------------------------

Tornier S.A., FRANCE Aequalis Reversed Shoulder Prosthesis

## SUMMARY STATEMENT

Page 1 of 1

K030941 510(k) Number:

## Aequalis Reversed Shoulder Prosthesis

Indications for Use:

Device Name:

The Aegualis Reversed Shoulder Prosthesis is indicated for patients, with a functional deltoid I ho requare to rever sou box 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 Aegualis 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.

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use X or

Per 21 CFR 801.109

ivision Division of General, Restorative, and Neurological Devices

710(k) Number K030941

Over-the-Counter Use -----

(Optional Format 1-2-96)