ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER

K052086 · Encore Medical, Inc. · PHX · Aug 31, 2005 · Orthopedic

Device Facts

• Record ID: K052086
• Device Name: ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER
• Applicant: Encore Medical, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Aug 31, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Encore Reverse Shoulder Prosthesis (RSP) is intended for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or 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. During primary surgery, after the humerus is prepared for the RSP humeral stem, if the glenoid bone stock appears "insufficient" to bear the load of the glenoid baseplate, a RSP humeral stem adapter can be used to convert the RSP humeral stem to a hemiarthroplasty prosthesis. During revision surgery of an RSP, if the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device; a RSP Humeral Stem Adapter is used to convert the RSP device to a hemiarthroplasty prosthesis.

Device Story

Reverse shoulder prosthesis; replaces standard shoulder anatomy by placing ball component on glenoid and cup component on humerus; requires functional deltoid muscle for operation. Used in orthopedic surgery for patients with severe rotator cuff deficiency or failed prior arthroplasty. Includes humeral stem adapter to convert device to hemiarthroplasty if glenoid bone stock is insufficient. Implanted by orthopedic surgeons in clinical/hospital settings. Provides mechanical joint replacement to restore function and reduce pain in patients with irreparable cuff damage.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate devices.

Technological Characteristics

Shoulder joint metal/polymer semi-constrained cemented prosthesis. Glenoid baseplate: cementless with screw fixation. Humeral stem: cemented. Includes humeral stem adapter for conversion to hemiarthroplasty. Materials and design consistent with previously cleared predicate devices.

Indications for Use

Indicated for patients with grossly rotator cuff deficient shoulder joints with severe arthropathy or failed prior joint replacement. Requires anatomically suitable joint and functional deltoid muscle. Also indicated for salvage of irreparable rotator cuff, failed hemi/total shoulder arthroplasty, and fractures with irreparable tuberosity/rotator cuff.

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

• Encore RSP (K041066)
• Encore RSP (K051075)

Submission Summary (Full Text)

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K052066 1.1

## AUG 3 1 2005

#### 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).

Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758 512-832-9500

Trade Name: Encore® Reverse® Shoulder Prosthesis (RSP)

Common Name:

Cemented semi-constrained total shoulder

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

#### Indications:

The Encore Reverse Shoulder Prosthesis (RSP) is intended for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or 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.

During primary surgery, after the humerus is prepared for the RSP humeral stem, if the glenoid bone stock appears "insufficient" to bear the load of the glenoid baseplate, a RSP humeral stem adapter can be used to convert the RSP humeral stem to a hemiarthroplasty prosthesis. During revision surgery of an RSP, if the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device; a RSP Humeral Stem Adapter is used to convert the RSP device to a hemiarthroplasty prosthesis.

#### Description:

The Encore Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff, failed hemi or total shoulder arthroplasty with irreparable rotator cuff, and for fracture in which the tuberosity and rotator cuff are irreparable. Unlike traditional total shoulders, the RSP is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup attached to the humeral stem. The RSP Humeral Stem Adapter is used to convert the RSP to a hemiarthroplasty when the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission.

#### Substantial Equivalence

The modified Encore RSP is similar in design, materials, and intended use to the previously cleared Encore RSP devices, K041066 and K051075.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

AUG 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christie Shumaker Encore Medical, L.P. 9800 Metric Boulevard Austin, Texas 78758

Re: K052086

Trade/Device Name: Encore Reverse Shoulder Prosthesis® (RSP) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: August 1, 2005 Received: August 3, 2005

Dear Ms. Shumaker:

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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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/industry/support/index.html.

Sincerely yours,

Cor Mark N. Melkerson 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): Kos Zo 8 h

Device Name: Encore Reverse Shoulder Prosthesis® (RSP)

Indications for Use:

The Encore Reverse Shoulder Prosthesis (RSP) is intended for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or 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.

During primary surgery, after the humerus is prepared for the RSP humeral stem, if the glenoid bone stock appears "insufficient" to bear the load of the glenoid baseplate, a RSP humeral stem adapter can be used to convert the RSP humeral stem to a hemiarthroplasty prosthesis. During revision surgery of an RSP, if the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device; a RSP Humeral Stem Adapter is used to convert the RSP device to a hemiarthroplasty prosthesis.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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510(k) Number_KOS 2096