(238 days)
No
The document describes a mechanical hip prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, a hip prosthesis, is used to treat medical conditions like severe hip pain, disability, and fractures, which falls under the definition of a therapeutic device.
No
This device is a hip prosthesis, an implant designed to replace the proximal femur in total hip arthroplasty, not to diagnose a condition.
No
The device description clearly states it is a physical hip prosthesis made of metal and PEEK, intended for surgical implantation. It is a hardware device, 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 provided text describes a hip prosthesis, which is an implantable medical device used to replace a damaged hip joint. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for treating severe hip pain and disability due to various conditions by replacing the proximal femur. This is a surgical intervention, not a diagnostic test.
The information provided describes a Class III medical device (an implant) used in surgery, 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.
This device is intended for cementless use only.
Product codes
LPH, JDL
Device Description
The VerSys Epoch FullCoat Hip stem is an addition to the currently marketed VerSys Epoch FullCoat proximal femoral hip implant family. It is a set of fully porous coated implants that are comprised of Zimaloy, a cobalt chromium molybdenum (CoCrMo) alloy core surrounded by a layer of injection molded polyetheretherketone (PEEK) encased in a layer of commercially pure titanium fiber metal (FM). The stem is designed to replace the proximal femur in a total hip arthroplasty. It features a 12/14 Morse-type taper to accommodate the attachment of modular femoral heads. The proximal geometry of the device is trapezoidal and comes in two options Reduced Neck Length (RNL) with 125° and 135° angles and Low Head Center (LHC) with a 125° angle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur, hip
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions: Mechanical testing of the device indicated that it is substantially equivalent to the legally market predicate.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VerSys® Epoch® FullCoat Hip System, K052321
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K073499 (pg. 1 of 2)
Summary of Safety and Effectiveness
| Submitter : | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eric S. Pittman
Associate, Corporate Regulatory Affairs
Telephone: (574) 371-8369
Fax: (574) 372-4605 |
| Date: | March 15, 2008 |
| Trade Name: | VerSys® Epoch® FullCoat Hip System |
| Common Name: | Proximal Femoral Prosthesis |
| Classification Name
and Reference: | Hip joint metal/metal semi-constrained, with a
cemented acetabular component, prosthesis (21
CFR § 888.3320-JDL) |
| Predicate Device: | VerSys® Epoch® FullCoat Hip System,
manufactured by Zimmer, Inc., K052321, cleared
February 15, 2006. |
| Device Description: | The VerSys Epoch FullCoat Hip stem is an addition
to the currently marketed VerSys Epoch FullCoat
proximal femoral hip implant family. It is a set of
fully porous coated implants that are comprised of
Zimaloy™, a cobalt chromium molybdenum
(CoCrMo) alloy core surrounded by a layer of
injection molded polyetheretherketone (PEEK)
encased in a layer of commercially pure titanium
fiber metal (FM). The stem is designed to replace
the proximal femur in a total hip arthroplasty. It
features a 12/14 Morse-type taper to accommodate
the attachment of modular femoral heads. The
proximal geometry of the device is trapezoidal and
comes in two options Reduced Neck Length (RNL) |
1
K073499 2 of 2 ్రామ్మ
with 125° and 135° angles and Low Head Center
(LHC) with a 125° angle.
:
| Intended 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.
This device is intended for cementless use only. |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | Compared to the predicate, the subject device has
the same intended use, similar physical and
performance characteristics and is manufactured
using similar processes. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | Mechanical testing of the device indicated that it is
substantially equivalent to the legally market
predicate. |
| | Clinical Performance and Conclusions: |
| | Clinical data and conclusions were not needed for
this device. |
2
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line. The text is black against a white background.
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its head turned to the left. The eagle's body is formed by three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
NOV 182008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Ms. Natalie S. Heck Sr. Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K073499 Trade/Device Name: VerSys® Epoch® FullCoat Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, JDL Dated: July 28, 2008 Received: July 30, 2008
Dear Ms. Heck:
This letter corrects our substantially equivalent letter of August 7, 2008.
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
3
Page 2 - Ms. Natalie S. Heck
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
Mark N. Melkerson 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): K073499
Device Name:
VerSys® Epoch® FullCoat Hip System
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.
This device is intended for cementless use only.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Or Division of General, Restorative, and Neurological Devices
073499
510(k) Number