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 Description

The Synthes Epoca Shoulder Prosthesis System is intended for partial or total replacement of the shoulder joint. The Synthes Epoca Shoulder Prosthesis System consists of metallic cemented and uncemented fixation stems (available with HA coating), humeral heads, an eccenter offset adjustment mechanism, and UHMWPE glenoid components. The components are available in a variety of sizes for primary and revision applications. The components are manufactured from CoCrMo Alloy, Titanium, and Ultra-High Molecular Weight Polyethylene (UHMWPE).

AI/ML Overview

This document is a 510(k) summary for the Synthes Epoca Shoulder Prosthesis System, HA Coated Stems. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving device performance against specific acceptance criteria.

Therefore, many of the requested sections (acceptance criteria, reported performance, sample sizes, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, training set size, and training set ground truth establishment) cannot be answered because the provided document does not contain this information.

The document does present the Device Name, Intended Use, and Predicate Devices, which are relevant to establishing substantial equivalence. However, it does not include a study with acceptance criteria and device performance results in the format requested.

The information primarily consists of regulatory details, such as device classification, contact information, and a re-affirmation of the indications for use. There is no evidence of a specific study designed to measure the device's performance against predefined acceptance criteria for attributes like accuracy, precision, or improved human performance.

In summary, the provided text is a regulatory submission for device clearance, not a clinical or performance study report.

Summary

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A SYNTHES®

FEB = 5 2009

3.0	510(k) Summary	Page 1 of 1
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Sponsor:	Synthes1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6604
Contact:	Amnon TalmorSynthes1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6604
Device Name:	Synthes Epoca Shoulder Prosthesis System, HA Coated Stems
Classification:	Class II, §888.3670 - Shoulder joint metal/polymer metalnonconstrained or semi-constrained porous-coated uncementedprosthesisClass II, §888.3690 - Shoulder joint humeral (hemi-shoulder)metallic uncemented prosthesis
Predicate Devices:	Synthes Epoca Shoulder Prosthesis SystemHowmedica Osteonics Solar PureFix HA Shoulder
Device Description:	The Synthes Epoca Shoulder Prosthesis System is intended forpartial or total replacement of the shoulder joint. The SynthesEpoca Shoulder Prosthesis System consists of metallic cementedand uncemented fixation stems (available with HA coating),humeral heads, an eccenter offset adjustment mechanism, andUHMWPE glenoid components. The components are available ina variety of sizes for primary and revision applications. Thecomponents are manufactured from CoCrMo Alloy, Titanium, andUltra-High Molecular Weight Polyethylene (UHMWPE).
Intended Use:	The Synthes Epoca Shoulder Prosthesis System is intended foruse as a hemi or total shoulder replacement. It is a single usedevice for reconstruction of the glenohumeral joint in the presenceof complex fractures (i.e., 3 and 4 part), revision of failed fixationor arthroplasty, post-traumatic mal-union and disabled, painfulshoulder joints resulting from various forms of arthropathy such asosteoarthritis, rheumatoid arthritis, traumatic arthritis or avascularnecrosis and other pathologies where arthrodesis is notacceptable. The Press-fit Titanium Plasma Sprayed HumeralStems 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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)); please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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:

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

Regulation Number and Section

§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.

(a)
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.(b)
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.”