(174 days)
Not Found
No
The document describes a mechanical hip prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
No.
A therapeutic device is one that treats a disease or condition. This device is a prosthesis, which replaces a body part but does not treat the underlying disease or condition that led to the need for the prosthesis. The device, the VerSys Epoch Fullcoat Hip Prosthesis, is an implant used to replace the proximal human femur, which is a structural replacement rather than a treatment.
No
The device described is a hip prosthesis, which is a surgical implant designed to replace a damaged hip joint, not to diagnose a condition.
No
The device description clearly states it is a "modular, metal-polymer composite femoral stem" designed to replace a part of the human femur, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The VerSys Epoch Fullcoat Hip Prosthesis is a surgical implant designed to replace a part of the human femur. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is to treat severe hip pain and disability by replacing the proximal femur, which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the VerSys Epoch Fullcoat Hip Prosthesis is a medical device, specifically a surgical implant, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VerSys Epoch Fullcoat Hip Prosthesis is indicated for:
- 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.
Product codes
LPH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal human femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K052321 pqu 142
FEB 1 5 2006
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher
Associate, Corporate Regulatory Affairs
Telephone: (574) 371-8083
Fax: (574) 372-4605 |
| Date: | August 24, 2005 |
| Trade Name: | VerSys® Epoch® Fullcoat Hip Prosthesis |
| Common Name: | Total Hip Prosthesis |
| Classification Name
and Reference: | Hip joint metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis
21 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 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. |
| Intended Use: | The VerSys Epoch Fullcoat Hip Prosthesis is
indicated for:
Patients suffering from severe hip pain and
disability due to rheumatoid arthritis, |
1
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):
2
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
3
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
4
Indications for Use
510(k) Number (if known):
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_
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