SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM

K083439 · Synthes (Usa) · MBF · Feb 5, 2009 · Orthopedic

Device Facts

• Record ID: K083439
• Device Name: SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
• Applicant: Synthes (Usa)
• Product Code: MBF · Orthopedic
• Decision Date: Feb 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Epoca Shoulder Prosthesis System is intended for use as a hemi or total shoulder replacement. It is a single use device for reconstruction of the glenohumeral joint in the presence of complex fractures (i.e., 3 and 4 part), revision of failed fixation or arthroplasty, post-traumatic mal-union and disabled, painful shoulder joints resulting from various forms of arthropathy such as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis and other pathologies where arthrodesis is not acceptable. The Press-fit Titanium Plasma Sprayed Humeral Stems are for cementless use only.

Device Story

The Synthes Epoca Shoulder Prosthesis System is a modular orthopedic implant for glenohumeral joint reconstruction. It comprises metallic humeral stems (cemented or uncemented with HA coating), humeral heads, an eccenter offset adjustment mechanism, and UHMWPE glenoid components. The device is implanted by orthopedic surgeons in a clinical/hospital setting. The system allows for anatomical restoration through various component sizes and offset adjustments. By replacing damaged joint surfaces, the prosthesis aims to alleviate pain and restore function in patients with severe arthropathy or fractures. The press-fit titanium plasma-sprayed stems are designed for cementless fixation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and technological similarities to legally marketed predicate devices.

Technological Characteristics

Materials: CoCrMo alloy, Titanium, UHMWPE. Features: Modular humeral stems (cemented/uncemented), humeral heads, eccenter offset adjustment mechanism, UHMWPE glenoid components. Fixation: Press-fit titanium plasma-sprayed stems for cementless use. Energy source: None (mechanical implant).

Indications for Use

Indicated for patients requiring hemi or total shoulder replacement due to complex fractures (3 and 4 part), revision of failed fixation or arthroplasty, post-traumatic mal-union, or painful shoulder joints from osteoarthritis, rheumatoid arthritis, traumatic arthritis, or avascular necrosis where arthrodesis is not acceptable.

Regulatory Classification

Identification

A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”

Predicate Devices

• Synthes Epoca Shoulder Prosthesis System
• Howmedica Osteonics Solar PureFix HA Shoulder

Submission Summary (Full Text)

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# A SYNTHES®

FEB = 5 2009

| 3.0 | 510(k) Summary | Page 1 of 1 |
|-----|----------------|-------------|
|-----|----------------|-------------|

| Sponsor: | Synthes<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Amnon Talmor<br>Synthes<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
| Device Name: | Synthes Epoca Shoulder Prosthesis System, HA Coated Stems |
| Classification: | Class II, §888.3670 - Shoulder joint metal/polymer metal<br>nonconstrained or semi-constrained porous-coated uncemented<br>prosthesis<br>Class II, §888.3690 - Shoulder joint humeral (hemi-shoulder)<br>metallic uncemented prosthesis |
| Predicate Devices: | Synthes Epoca Shoulder Prosthesis System<br>Howmedica Osteonics Solar PureFix HA Shoulder |
| Device Description: | The Synthes Epoca Shoulder Prosthesis System is intended for<br>partial or total replacement of the shoulder joint. The Synthes<br>Epoca Shoulder Prosthesis System consists of metallic cemented<br>and uncemented fixation stems (available with HA coating),<br>humeral heads, an eccenter offset adjustment mechanism, and<br>UHMWPE glenoid components. The components are available in<br>a variety of sizes for primary and revision applications. The<br>components are manufactured from CoCrMo Alloy, Titanium, and<br>Ultra-High Molecular Weight Polyethylene (UHMWPE). |
| Intended Use: | The Synthes Epoca Shoulder Prosthesis System is intended for<br>use as a hemi or total shoulder replacement. It is a single use<br>device for reconstruction of the glenohumeral joint in the presence<br>of complex fractures (i.e., 3 and 4 part), revision of failed fixation<br>or arthroplasty, post-traumatic mal-union and disabled, painful<br>shoulder joints resulting from various forms of arthropathy such as<br>osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular<br>necrosis and other pathologies where arthrodesis is not<br>acceptable. The Press-fit Titanium Plasma Sprayed Humeral<br>Stems are for cementless use only. |
| Substantial Equivalence: | The information presented supports substantial equivalence. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB - 5 2009

Synthes (USA) % Mr. Amnon Talmor Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K083439

> Trade/Device Name: Synthes Epoca Shoulder Prosthesis System Regulation Number: 21 CFR 888.3670

Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semiconstrained porous-coated uncemented prosthesis.

Regulatory Class: II Product Code: MBF, HSD, KWT Dated: November 19, 2008 Received: November 24, 2008

Dear Mr. Talmor:

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. Iisting 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

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Page 2 - Mr. Amnon Talmor

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 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.

Mark N Mulhausen

- Mark 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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2.0

Indications for Use

K083439

510(k) Number (if known):

Device Name:

Synthes Epoca Shoulder Prosthesis System

Indications for Use:

The Synthes Epoca Shoulder Prosthesis System is intended for use as a hemi or total shoulder replacement. It is a single use device for reconstruction of the glenohumeral joint in the presence of complex fractures (i.e., 3 and 4 part), revision of failed fixation or arthroplasty, post-traumatic mal-union and disabled, painful shoulder joints resulting from various forms of arthropathy such as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis and other pathologies where arthrodesis is not acceptable. The Press-fit Titanium Plasma Sprayed Humeral Stems are for cementless use only.

Prescription Use (Per 21 CFR 801.109) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE ( CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division 200-2017 Division of General, Restorative, and Neurological Devices

510(k) Number