DELTA XTEND REVERSE SHOULDER MODULAR STEM

K071379 · DePuy Orthopaedics, Inc. · PHX · Sep 11, 2007 · Orthopedic

Device Facts

• Record ID: K071379
• Device Name: DELTA XTEND REVERSE SHOULDER MODULAR STEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Sep 11, 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, with or without bone cement. HA coated components are for cementless use only.

Device Story

Modular shoulder prosthesis; designed for total or hemi-arthroplasty in patients with non-functional rotator cuffs. System components include humeral stem, epiphysis, and metaglene; HA-coated components allow cementless fixation; others require bone cement. Used by orthopedic surgeons in clinical/surgical settings. Device replaces damaged joint surfaces to restore function in cuff-deficient shoulders. Clinical benefit derived from mechanical stabilization of joint and restoration of shoulder mobility.

Clinical Evidence

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

Technological Characteristics

Modular shoulder prosthesis; components include humeral stem, epiphysis, and metaglene. Materials include HA-coated surfaces for cementless fixation and standard metallic/polymeric materials for cemented components. Semi-constrained design.

Indications for Use

Indicated for patients with grossly rotator cuff deficient joints with severe arthropathy or previous failed joint replacement. Requires anatomically/structurally suited joint and functional deltoid muscle. Monobloc implant indicated for proximal humerus bone defects with sufficient residual bone for fixation. Hemi-arthroplasty indicated for intraoperative glenoid fracture or revision of failed Delta Xtend Reverse Shoulder.

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

• Delta Xtend™ Reverse Shoulder System (K062250)
• DePuy Delta CTA Reverse Shoulder System (K021478)
• DePuy Global Advantage Shoulder System (K992065)

Submission Summary (Full Text)

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K071379

SEP 1 1 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.

| | Section 5 - 510 (k) Summary |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Establishment Registration Number: 1818910 |
| Manufacturer: | DePuy France S.A.<br>Z I La Vendue BP88 |
| Establishment<br>Registration Number: | Chaumont<br>52003 France<br>Establishment Registration Number: 9615674 |
| 510(K) CONTACT: | Kathy Harris<br>Director, Regulatory Affairs<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | May 15, 2007 |
| PROPRIETARY NAME: | Delta Xtend™ Reverse Shoulder Modular Stem |
| COMMON NAME: | Shoulder Prosthesis |
| CLASSIFICATION: | Class II Device per 21 CFR §888.3660:<br>Prosthesis, Shoulder, Semi-Constrained,<br>Metal/Polymer Cemented<br>Class II Device per 21 CFR §888.3690:<br>Prosthesis, Shoulder, Hemi-, Humeral, Metallic<br>Uncemented |
| DEVICE PRODUCT CODE: | 87 KWS<br>87 HSD |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE: | Delta Xtend™ Reverse Shoulder System,<br>K062250<br>DePuy Delta CTA Reverse Shoulder System,<br>K021478<br>DePuy Global Advantage Shoulder System,<br>K992065 |

:

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### DEVICE DESCRIPTION:

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

#### 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, with or without bone cement. HA coated components are for cementless use only.

#### Indications for Use:

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

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

The modular humeral stem and epiphysis components are HA coated and intended for cementless use.

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 Xtend Reverse Shoulder System (K062250), the DePuy Delta CTA Reverse Shoulder System (K021478), and the DePuy Global Advantage Shoulder System (K992065).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Natalie S. Heck Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, IN 46581

SEP 1 1 2007

Re: K071379 Trade/Device Name: Delta Xtend™ Reverse Shoulder Modular Stem Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prothesis Regulatory Class: Class II Product Code: KWS, HSD Dated: August 15, 2007 Received: August 16, 2007

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 S. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Soubary Bouchus

Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K071379 (pg 1/1)

## Section 4 - Indications for Use Statement

510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Delta Xtend The Reverse Shoulder Modular Stem

#### Indications for Use:

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

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

The modular humeral stem and epiphysis components are HA coated and intended for cementless use.

All other components are for cemented use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Posted November 13, 2003) Division of General, Restorative
and Neurological Devices

510(k) Number K071379

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