DELTA XTEND REVERSE SHOULDER SYSTEM

K062250 · DePuy Orthopaedics, Inc. · PHX · Feb 2, 2007 · Orthopedic

Device Facts

• Record ID: K062250
• Device Name: DELTA XTEND REVERSE SHOULDER SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Feb 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Delta Xtend™ Reverse Shoulder prosthesis is intended for use in total or hemi shoulder arthroplasty procedures in patients with non-functional rotator cuffs.

Device Story

Modular shoulder prosthesis for total or hemi-shoulder arthroplasty; designed for patients with non-functional rotator cuffs and functional deltoid muscles. System replaces damaged joint components to restore function. Metaglene component features HA coating for cementless fixation with screws; all other components require cement. Used in clinical settings by orthopedic surgeons. Device provides mechanical structural support for the shoulder joint; benefits patients by addressing severe arthropathy or failed prior replacements where rotator cuff is deficient.

Clinical Evidence

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

Technological Characteristics

Modular shoulder prosthesis. Materials include metal and polymer. Metaglene component is HA (hydroxyapatite) coated for cementless fixation; other components are for cemented use. Semi-constrained design.

Indications for Use

Indicated for total or hemi-shoulder replacement in patients with grossly deficient rotator cuff joints, severe arthropathy, or failed previous joint replacement. Requires anatomically/structurally suited joint and functional deltoid muscle. Hemi-arthroplasty indicated if glenoid fractured intraoperatively. Proximal humerus bone defects require monobloc implant with sufficient residual bone for fixation.

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 CTA Reverse Shoulder System (K021478)
• DePuy Global Advantage Shoulder System (K992065)
• DePuy Global Advantage CTA Head (K000575)

Reference Devices

• DePuy Delta CTA Head (K062116)

Submission Summary (Full Text)

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.062250

FEB - 2 2007

\$

Pursuant to Section 510(k) of the Federal Food, Drug, and Cosmetic Act and in accordance with subpart E of Part 807 of Title 21 of the Code of Federal Regulations and the Safe Medical Devices Act of 1990.

| | NAME | OF | SPONSOR: | |
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#### 510 (k) Summary

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Establishment Registration Number: 1818910

510(K) CONTACT:

Natalie Heck Manager, Regulatory Affairs Telephone: [phone] Facsimile: [phone] Electronic Mail: nheck(@dpyus.jnj.com

DATE PREPARED: July 26, 2006 Delta Xtend™ Reverse Shoulder System PROPRIETARY NAME:

COMMON NAME:

CLASSIFICATION:

Class II Device per 21 CFR 888.3660:

Shoulder Prosthesis

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class II Device per 21 CFR §888.3690: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented 87 KWS 87 HSD

# DEVICE PRODUCT CODE:

SUBSTANTIALLY EQUIVALENT DePuy Delta CTA Reverse Shoulder System, DEVICE: K021478 DePuy Global Advantage Shoulder System, K992065 DePuy Global Advantage CTA Head (cleared as the DePuy Global Advantage Extended Head) K000575

#### DEVICE DESCRIPTION:

The Delta Xtend™ Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.

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062250

p. 2/2

#### INTENDED USE AND INDICATIONS:

#### Intended Use:

The Delta Xtend™ Reverse Shoulder prosthesis is intended for use in total or hemi shoulder arthroplasty procedures in patients with non-functional rotator cuffs.

#### Indications for Use:

The Delta Xtend™ Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement.

Delta Xtend™ Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff 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.

In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.

Delta Xtend™ hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively.

The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.

All other components are for cemented use only.

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

The substantial equivalence of the Delta Xtend™ Reverse Shoulder is substantiated by its similarity in intended use, indications for use, materials and design to the DePuy Delta CTA Reverse Shoulder System (K021478), the DePuy Delta CTA Head (K062116), the DePuy Global Advantage Shoulder System (K992065), and the DePuy Global Advantage CTA Head (K000575, cleared as the DePuy Global Advantage Extended Head).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized wing strokes, symbolizing strength and freedom. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. c/o Ms. Natalie Heck Manager, Regulatory Affairs P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

FEB - 2 2007

Re: K062250

Trade Name: Delta Xtend™ Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS. HSD Dated: December 4, 2006 Received: December 6, 2006

Dear Ms. Heck:

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. Natalie Heck

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 vours.

Sincerely yours,

Barbara Buchud

Mark N. Melkerson, M.S 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 Statement

K062250 510 (k) Number (if known):

Device Name: Delta Xtend TM Reverse Shoulder System_

#### Indications for Use:

The Delta Xtend "10 Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement.

Delta Xtend™ Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff 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.

In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.

Delta Xtend 10 hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively.

The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.

All other components are for cemented use only.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbare rich For MONT

and Neurologica

Page of

510(k) Number K062252

0000030