ENCORE REVERSE SHOULDER PROSTHESIS

K041066 · Encore Medical L.P. · PHX · Mar 24, 2005 · Orthopedic

Device Facts

• Record ID: K041066
• Device Name: ENCORE REVERSE SHOULDER PROSTHESIS
• Applicant: Encore Medical L.P.
• Product Code: PHX · Orthopedic
• Decision Date: Mar 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Reverse Shoulder is indicated for use in patients with grossly rotator cuff deficient shoulder joints and for patients with a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

Device Story

The Encore Reverse Shoulder Prosthesis is a total shoulder replacement system designed for patients with non-functional rotator cuffs. Unlike traditional shoulder prostheses, this device features an 'inverted' articulation: the ball component attaches to the glenoid baseplate, and the cup component attaches to the humeral stem. The glenoid baseplate is designed for cementless fixation using a central 6.5mm cancellous screw and four peripheral screws (3.5mm non-locking and/or 5.0mm locking/non-locking). The humeral stem is designed for cemented fixation. The device is implanted by an orthopedic surgeon in a clinical/surgical setting. By reversing the joint mechanics, the device relies on the deltoid muscle rather than the rotator cuff to provide shoulder function, potentially restoring mobility and reducing pain in patients who are otherwise unsuitable for standard total shoulder arthroplasty.

Technological Characteristics

Total shoulder prosthesis; semi-constrained; metal/polymer construction. Features inverted ball-and-socket geometry. Glenoid baseplate: porous coated, cementless, fixed with one 6.5mm cancellous screw and four peripheral screws (3.5mm/5.0mm). Humeral stem: cemented. Designed for patients with non-functional rotator cuffs requiring deltoid-driven articulation.

Indications for Use

Indicated for patients with grossly rotator cuff deficient shoulder joints or failed joint replacements with rotator cuff deficiency. Requires anatomically/structurally suitable joint and functional deltoid muscle.

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

• DePuy Delta Shoulder (K0231478)

Submission Summary (Full Text)

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K041066

# Summary of Safety and Effectiveness

Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758 512-834-6237

MAR 2 4 2005

Trade Name: Encore Reverse Shoulder Prosthesis

Common Name: Cemented semi-constrained total shoulder

Classification Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3660

#### Indications:

millications:
The Reverse Shoulder is indicated for use in patients with grossly rotator cuff deficient The Neverse Bhoulder is mother is meetiously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

## Description:

The Reverse Shoulder Prosthesis is a total shoulder prosthesis designed specifically for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prosthesis'. Unlike traditional total shoulders, the Reverse Shoulder is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into the humeral stem. The distal surface of the glenoid baseplate is porous coated with an incorporated 6.5 cancellous screw and is intended to be used with 4 peripheral screws (3.5 non-locking and/or 5.0mm locking and non-locking) for additional fixation.

## Substantial Equivalence

The Encore Reverse Shoulder is equivalent to the DePuy Delta Shoulder (K0231478).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines that resemble a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2005

Ms. Christie Shumaker Regulatory Affairs Specialist 9800 Metric Blvd Austin, Texas 78758

Re: K041066

Trade/Device Name: Encore Reverse Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/ polymer semi-constrained prosthesis Regulatory Class: II Product Code: KWS Dated: February 28, 2005 Received: March 1, 2005

Dear Ms. De Los Santos:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or to comments provided in accordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merclore, market the as not include requirements for annual registration, listing of general controls provisions of the fiel 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 If your device is classified (600 a00 70) of cols. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation thay be subject to such additions, 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 or any I ederal statuates and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K F art 6077, adoning (27 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. Christie Shumaker

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally premitsel notification. The PDA mianing of basification 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 If you desire specific advice for your do not on on the splease note the regulation entitled, and colliact the Office of Comphanes at (21 t 7 ) = 1 / 21 FR Part 807.97). You may obtain " Misoranding by responsibilities to premainceased in the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] of Manufacturers, International and Consumer instruction.cov/cdrh/industry/support/index.html.

Sincerely yours,

Stypt Charles

Miriam 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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#### Indications for Use

# 510 (k) Number (if known): ★6 4L0L ん

Encore Reverse Shoulder Prosthesis Device Name:

Indications for Use:

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implant(s), and a functional deltoid muscle is necessary to use comment for fixetion implant(s), and a functional denold musele is necessary to as the more for fixation. The humeral stem is intended for cemented use only.

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

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hipt. Dworlus

Division of General, Restorative, and Neurological Devices

KO41066 510(k) Number __