DELTA SHOULDER

K021478 · Depuy, Inc. · PHX · Nov 18, 2003 · Orthopedic

Device Facts

• Record ID: K021478
• Device Name: DELTA SHOULDER
• Applicant: Depuy, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Nov 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A Delta Total shoulder prosthesis is indicated for use in: 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. 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.

Device Story

Modular total shoulder prosthesis designed for patients with non-functional rotator cuffs. Features inverted articulation: glenoid component contains the 'ball' and humeral component contains the 'cup'. Metaglene component features hydroxyapatite (HA) coating for cementless fixation with screws; remaining components require cement. Used by orthopedic surgeons in clinical settings to replace damaged shoulder joints. Device restores joint function in patients where traditional prostheses are unsuitable due to rotator cuff deficiency.

Clinical Evidence

No clinical data provided; substantial equivalence supported by device description, design rationale, and bench testing.

Technological Characteristics

Modular shoulder prosthesis; metal/polymer construction. Metaglene component features hydroxyapatite (HA) coating for cementless fixation; other components cemented. Inverted articulation design (glenoid ball, humeral cup).

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.

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

• Biomet Bio-Modular and Bipolar Shoulder (K992119 and K991585)
• Global Advantage Shoulder (K992065)

Submission Summary (Full Text)

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NOV 1 8 2003

# 510(k) Summary Delta Shoulder

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

A. Contact Person:

Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs [phone]

### B. Device Information:

| Proprietary Name: | Delta Shoulder |
|----------------------------------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Shoulder Prosthesis |
| Classification Name and<br>Regulatory Class: | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented:<br>Class II per 21 CFR §888.3660 |
| Product Code: | 87 KWS |

### Indications for Use: C.

A Delta Total shoulder prosthesis is indicated for use in: 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.

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.

## D. Device Description:

The Delta Shoulder prosthesis is a modular total shoulder prosthesis that was designed specifically for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prosthesis. Unlike traditional total shoulder prosthesis, the Delta Shoulder is designed such that the "ball" of the articulation is incorporated into the glenoid prosthesis, and the "cup" of the articulation is incorporated in the humeral prosthesis. The distal surface of the metaglene components are coated with a hydroxyapatite coating (HA) and are intended to be used with 4 metaglene screws for fixation.

#### E. Substantial Equivalence:

The substantial equivalence of the Delta Shoulder is substantiated by its similarity in indications for use. design, sterilization and packaging to the Biomet Bio-Modular and Bipolar Shoulder (K992119 and K991585), and the Global Advantage Shoulder (K992065).

The determination of substantial equivalence for this device was based on a detailed device description. design rationale, product testing, literature and conformance with voluntary performance standards.

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Public Health Service

NOV 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K021478

Trade/Device Name: Delta Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: August 25, 2003 Received: August 27, 2003

Dear Dr. Weissman:

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 10 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 - Dina L. Weissman, J.D.

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/dsma/dsmamain.html

Sincerely vours.

Mark A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) Device Name

K021478 Delta Shoulder

# Indications for Use

A Delta Total shoulder prosthesis is indicated for use in:

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.

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.

OR

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Wilkerson
(Division Sign-Off)

Division of Ceneral, Restorative and Neurological Devices

510(k) Number K021478

Prescription Use (Per 21 CFR §801.109) Over-the-Counter Use

(Optional Format 1-2-96)