DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS

K062116 · DePuy Orthopaedics, Inc. · PHX · Aug 18, 2006 · Orthopedic

Device Facts

• Record ID: K062116
• Device Name: DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Aug 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Delta CTA Reverse Shoulder System Humeral Head is intended for use in hemi arthroplasty procedures (without the humeral cup or glenoid components) if the glenoid is fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.

Device Story

Modular shoulder prosthesis humeral head component; used in hemi-arthroplasty procedures for patients with grossly deficient rotator cuffs and severe arthropathy or failed prior replacements. Device replaces humeral head; requires functional deltoid muscle for operation. Implanted by orthopedic surgeons in clinical/surgical settings. Provides structural joint replacement to restore function and reduce pain in patients with insufficient glenoid bone stock or intraoperative glenoid fractures. Components are intended for cemented use, except for specific HA-coated metaglene components requiring cementless fixation with screws.

Technological Characteristics

Modular shoulder prosthesis; metallic construction. Metaglene component features HA (hydroxyapatite) coating for cementless application; other components designed for cemented use. Fixation via screws for cementless components.

Indications for Use

Indicated for patients with grossly deficient rotator cuff joints with severe arthropathy or previous failed joint replacement with grossly deficient rotator cuff. Requires anatomically/structurally suited joint and functional deltoid muscle. Contraindicated if these conditions are not met.

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 CTA Head (K000525)

Submission Summary (Full Text)

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K063116 page 142

AUG 1 8 2006

## 510 (k) Summary (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 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer<br>Regulatory Affairs<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | July 17, 2006 |
| PROPRIETARY NAME: | Delta CTA™ Reverse Shoulder System Humeral<br>Heads |
| COMMON NAME: | Shoulder Prosthesis |
| CLASSIFICATION: | Class II Device per 21 CFR 888.3660:<br>Prosthesis, Shoulder, Semi-Constrained,<br>Metal/Polymer Cemented; and<br>888.3690: Shoulder Joint Humeral (hemi-<br>shoulder) Metallic Uncemented Prosthesis |
| DEVICE PRODUCT CODE: | 87 KWS<br>87 HSD |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE: | DePuy Delta CTA Reverse Shoulder System,<br>K021478<br>DePuy Global Advantage CTA Head. K000525 |

### DEVICE DESCRIPTION:

The Delta CTA 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 CTA Reverse Shoulder System Humeral Head is intended for use in hemi arthroplasty procedures (without the humeral cup or glenoid components) if the glenoid is

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fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.

## Indications for Use:

A Delta CTA™ 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.

The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2006

DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K062116

Trade/Device Name: Delta CTA™ Reverse Shoulder Humeral Heads 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: July 24, 2006 Received: July 25, 2006

Dear Ms. Myer:

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA

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## Page 2 - Ms. Rhonda Myer

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" (21 CFR 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/cdrl/industry/support/index.html.

Sincerely yours,

Barbara Buechner

fark N. Melkerson 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

510 (k) Number (if known): K062116
Device Name: Delta CTA™ Reverse Shoulder Humeral Heads

#### Indications for Use:

A Delta CTA 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.

The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(Please do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbare Buch

(Posted November 13, 2003) (Division Sign-Off) Page 1 of 1

Division of General, Restorative,
and Neurological Devices

510(k) Number K062110

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