Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
Patients suffering from disability due to previous fusion.
Patients with acute femoral neck fractures.

Device Description

The VerSys Epoch Fullcoat Hip Prosthesis is a modular, metal-polymer composite femoral stem designed to replace the proximal human femur in total hip arthroplasty. It features a 12/14 Morse-type taper to accommodate the attachment of modular femoral heads. The proximal body geometry of the proposed device is trapezoidal and two body options (standard and large metaphysis) are offered in sizes 13mm through 22mm to meet patient anatomical requirements. The VerSys Epoch Fullcoat Hip Prosthesis is available in both standard and extended neck offsets to allow for restoration of optimal joint kinematics and maximum stability without altering leg length.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device: the VerSys® Epoch® Fullcoat Hip Prosthesis. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance data from a study that uses acceptance criteria. Hip prostheses are typically cleared based on mechanical performance testing and material equivalence to previously cleared devices, not clinical studies with acceptance criteria for algorithm performance.

Therefore, the specific information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not applicable and cannot be extracted from the provided text. The document explicitly states:

"Non-Clinical Performance and Conclusions: Non-clinical testing demonstrated that this device met performance requirements and is as safe and effective as the predicate device."
"Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

This means the device was cleared based on non-clinical (e.g., mechanical) testing, and no human-in-the-loop or standalone algorithm performance studies were conducted or required for this type of device and regulatory pathway.

Summary

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K052321 pqu 142

FEB 1 5 2006

Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Brandon HipsherAssociate, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605
Date:	August 24, 2005
Trade Name:	VerSys® Epoch® Fullcoat Hip Prosthesis
Common Name:	Total Hip Prosthesis
Classification Nameand Reference:	Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis21 CFR § 888.3358
Predicate Device:	Epoch Hip Prosthesis, manufactured by Zimmer,Inc., K014070, cleared July 30, 2002
Device Description:	The VerSys Epoch Fullcoat Hip Prosthesis is amodular, metal-polymer composite femoral stemdesigned to replace the proximal human femur intotal hip arthroplasty. It features a 12/14 Morse-type taper to accommodate the attachment ofmodular femoral heads. The proximal bodygeometry of the proposed device is trapezoidal andtwo body options (standard and large metaphysis)are offered in sizes 13mm through 22mm to meetpatient anatomical requirements. The VerSys EpochFullcoat Hip Prosthesis is available in both standardand extended neck offsets to allow for restoration ofoptimal joint kinematics and maximum stabilitywithout altering leg length.
Intended Use:	The VerSys Epoch Fullcoat Hip Prosthesis isindicated for:Patients suffering from severe hip pain and-disability due to rheumatoid arthritis,

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osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.

Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
Patients suffering from disability due to ្រ previous fusion.
Patients with acute femoral neck fractures. -

The VerSys Epoch Fullcoat Hip Prosthesis is manufactured from similar materials to those used in the predicate device. It is packaged and sterilized using the same materials and processes as the predicate device.

Non-Clinical Performance and Conclusions:

Non-clinical testing demonstrated that this device met performance requirements and is as safe and effective as the predicate device.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The text is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2006

Mr. Brandon Hipsher Associate, Corporate Regulatory Affairs, Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581

K052321 Re:

Trade/Device Name: VerSys® Epoch® Fullcoat Hip Prosthesis Regulation Number: 21 CFR § 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH

Dated: January 26, 2006 Received: January 30, 2006

Dear Mr. Hipsher:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 9 rotty premier is substantially equivalent (for the indications felerenced above und nave december and and and and one ices marketed in interstate for use stated in the encrosale) to tegans comment date of the Medical Device Amendments, or to commerce price to May 20, 1978, the exact ance with the provisions of the Federal Food, DRAA devices that have been roomsomed in assee approval of a premarket approval application (PMA). alle Cosmetic Act (710) that to not require of the general controls provisions of the Act. The I ou may, mercere, manel and not include requirements for annual registration, listing of general controls provisions of the recollabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 world) and controls. Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of reacts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that 1 Dr1 3 lisualite of a colesvice complies with other requirements of the Act that I DA has made a dolorimation administered by other Federal agencies. You must of any I cuclar statutes and regulations annuding, but not limited to: registration and listing (2 l Comply with an the Het orequirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Mr. Brandon Hipsher

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) rogalations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000product radiation control provisions (Declions 091 - vice as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your S I his letter will anow you to begin manothig your as no reast of your devertise your devents premarket notification. The PDF Imaling of basification 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 If you desire specific advice for your as 110 %. 4639. Also, please note the regulation entitled, Conlact the Office of Compilance at (301) of fication" (21CFR Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) you may ob Misolanding by telefone to premarksonsibilities under the Act may be obtained from the Oiller general mibilination on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark N. Melkerson Acting 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):

K052321

Device Name:

VerSys® Epoch® Fullcoat Hip Prosthesis

Indications for Use:

The VerSys Epoch Fullcoat Hip Prosthesis is indicated for:

e VerSys Epoch Fulleoat Thp Frostheals and disability due to rheumatoid arthrilis, ו Patients suffering Iront severe inp pain and the disorders, avascular necrosis of osteoalthritis, tradmatic artifical, poly fractures of the femur.
the temoral head, and fionalion of previous fractures of the same of the moral epiphysis.
Patients suffering from disability due to previous fusion. -
Patients with acute femoral neck fractures. -

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

RH. Office of Device Evaluation (ODE) Concurrence of

Hult
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_

Page 1 of 1

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. 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. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.