MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM

K081620 · DePuy Orthopaedics, Inc. · KWS · Jun 30, 2008 · Orthopedic

Device Facts

• Record ID: K081620
• Device Name: MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Jun 30, 2008
• Decision: SESE
• Submission Type: Special
• 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-shoulder arthroplasty in patients with non-functional rotator cuffs. System replaces damaged glenohumeral joint components; restores shoulder function in patients with severe arthropathy or failed prior replacements. Requires functional deltoid muscle for operation. Components include HA-coated elements for cementless fixation and others for cemented use. Implanted by orthopedic surgeons in clinical/surgical settings. Provides structural replacement of joint; enables patient mobility and pain relief.

Clinical Evidence

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

Technological Characteristics

Modular shoulder prosthesis; metal/polymer construction. Features HA (hydroxyapatite) coating on specific components (metaglene, modular humeral stem, epiphysis) for cementless fixation. Other components designed for cemented use. Semi-constrained design.

Indications for Use

Indicated for patients with grossly deficient rotator cuff and severe arthropathy or failed joint replacement. Requires anatomically/structurally suited joint and functional deltoid muscle. Hemi-shoulder replacement indicated for hemi-arthroplasty if glenoid fractured intraoperatively or for revision of failed Delta Xtend Reverse Shoulder. Monobloc implant indicated for proximal humerus bone defects 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 Xtend Reverse Shoulder System (K062250)
• DePuy Delta Xtend Reverse Shoulder System (K073676)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2016

DePuy Orthopaedics, Incorporated Ms. Rhonda Myer Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K081620

Trade/Device Name: DePuy 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: PHX, KWS, HSD Dated: June 6, 2008 Received: June 9, 2008

Dear Ms. Myer:

This letter corrects our substantially equivalent letter of June 30, 2008.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# KO 81620

# Indications for Use Statement

510 (k) Number (if known):

Device Name: DePuy Delta Xtend Reverse Shoulder System

Indications for Use:

The 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 cascs 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 Della 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 X (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)

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DePuy Orthopaedics, Inc.

**510(k) Number** K081162
Delta Xtend Reverse Shoulder System

Page 11 of 66

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K081620

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| | JUN 30 2008<br><b>510 (k) Summary</b><br>(As required by 21 CFR 807.92 and 21 CFR 807.93) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46582<br>Establishment Registration Number: 1818910 |
| MANUFACTURER: | DePuy France SAS<br>7 Allée Irène Joliot Curie<br>69801 Saint Priest Cedex France<br>Establishment Registration: 3003895575 |
| 510(K) CONTACT: | Rhonda Myer<br>Regulatory Affairs Associate<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | June 4, 2008 |
| PROPRIETARY NAME: | DePuy Delta Xtend Reverse Shoulder System |
| COMMON NAME: | Shoulder Prosthesis |
| CLASSIFICATION: | Class II per 21 CFR 888.3660: Prosthesis,<br>Shoulder, Semi-Constrained, Metal/Polymer<br>Cemented |
| DEVICE PRODUCT CODE: | 87 KWS<br>87 HSD |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE: | DePuy Delta Xtend Reverse Shoulder System<br>K062250 and K073676 |

### DEVICE DESCRIPTION:

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

## INDICATIONS AND INTENDED USE:

#### Indications:

. A

The 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.

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081620.

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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.

#### Intended Use:

P

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.

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on the similarities in intended use, indications for use, materials, design, method of manufacture, sterilization and packaging methods, DePuy believes the subject Delta Xtend Reverse Shoulder System is substantially equivalent to the previously cleared Delta Xtend Reverse Shoulder System, K062250 and K073676.