SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM

K072578 · Synthes (Usa) · HSD · Nov 28, 2007 · Orthopedic

Device Facts

• Record ID: K072578
• Device Name: SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HSD · Orthopedic
• Decision Date: Nov 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Shoulder prosthesis system for hemi or total joint replacement; used for reconstruction of glenohumeral joint. Components include metallic cemented/uncemented fixation stems, humeral heads, eccenter offset adjustment mechanism, and UHMWPE glenoid components. Available in various sizes for primary and revision applications. Implanted by surgeons in clinical settings. Provides structural replacement for damaged or diseased shoulder joints; restores joint function; reduces pain associated with arthropathy or trauma. Press-fit titanium plasma-sprayed stems designed for cementless fixation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: CoCrMo alloy, Titanium, and UHMWPE. Components: Humeral stems (cemented/uncemented), humeral heads, eccenter offset adjustment mechanism, UHMWPE glenoid components. Fixation: Cemented or cementless (press-fit titanium plasma-sprayed).

Indications for Use

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

Regulatory Classification

Identification

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

Predicate Devices

• ARGOMedical EPOCA Custom Offset Shoulder System
• Tornier Aequalis Shoulder Fracture System
• Aequalis Shoulder System

Submission Summary (Full Text)

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K072578(pg 1/1)

# SYNTHES®

| 3.0 | 510(k) Summary | | Page 1 of 1 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|
| Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>[phone] | | |
| Contact: | Sheri L. Musgnung<br>Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] | | NOV 2 8 2007 |
| Device Name: | Synthes Epoca Shoulder Prosthesis System | | |
| Classification: | Class II, §888.3650 - Shoulder-joint metal/polymer nonconstrained<br>cemented prosthesis | | |
| Predicate Device: | ARGOMedical EPOCA Custom Offset Shoulder System<br>Tornier Aequalis Shoulder Fracture System & Aequalis Shoulder<br>System | | |
| 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, humeral heads, an eccenter offset<br>adjustment mechanism, and UHMWPE glenoid components. The<br>components are available in a variety of sizes for primary and<br>revision applications. The components are manufactured from<br>CoCrMo Alloy, Titanium, and Ultra-High Molecular Weight<br>Polyethylene (UHMWPE). | | |
| Intended Use: | Synthes Epoca Shoulder Prosthesis System is intended for use as a<br>hemi or total shoulder replacement. It is a single use device for<br>reconstruction of the glenohumeral joint in the presence of complex<br>fractures (i.e. 3 and 4 part), revision of failed fixation or<br>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 acceptable.<br>The Press-fit Titanium Plasma Sprayed Humeral Stems are for<br>cementless use only. | | |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. | | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2007

Synthes (USA) % Ms. Sheri L. Musgnung 1301 Goshen Parkway West Chester, PA 19380

K072578 Re:

Trade/Device Name: Synthes (USA) Epoca Shoulder Prosthesis System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT, MBF, HSD Dated: September 12, 2007 Received: September 14, 2007

Dear Ms. Musgnung:

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. Sheri L. Musgnung

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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Milliman

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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#### Indications for Use

510(k) Number (if known):

## K072578 (ps 1/1)

Device Name:

2.0

Synthes (USA) Epoca Shoulder Prosthesis System

Indications for Use:

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 glenolumeral joint in the presence of complex fractures (i.e. 3 and 4 part), revision of failed fixation or arthroplasty, post-traumatic malunion 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)

te of Device Evaluation (ODE)

(Division Sign-Off) (Division Sign of General, Restorative, and Neurological Devi

510(k) Number