(37 days)
No
The summary describes a mechanical hip prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a prosthesis designed to replace parts of the hip, specifically indicated for conditions causing severe hip pain and disability, and also for hip fractures, which aligns with the definition of therapeutic devices aiming to treat or alleviate a medical condition.
No.
The device is a hip prosthesis, which is an implant used for hip replacement surgery. Its intended use is to replace a damaged hip, not to diagnose a condition.
No
The device description clearly states it is a modular femoral stem manufactured from Co-Cr-Mo alloy with a porous surface coating, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to replace parts of the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of metal alloys, not reagents, instruments, or systems used to examine specimens from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting substances, or providing information for diagnosis.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue) to diagnose diseases or conditions. This device is a prosthetic implant used in the body to treat existing conditions.
N/A
Intended Use / Indications for Use
The VerSys Beaded FullCoat Calcar Hip Prosthesis is designed to achieve biologic fixation to bone and is indicated for:
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability due to previous fusion, previously failed endoprostheses and/or total hip components in the affected extremity, and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip, elderly, debilitated patients when a total hip replacement is contraindicated, irreducible fractures in which adequate fixation cannot be obtained, certain high subcapital fractures and comminuted fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis in which the femoral head is primarily affected.
Product codes
LPH
Device Description
Like its predicate, the VerSys Beaded FullCoat Calcar Hip Prosthesis is a modular femoral stem manufactured from Co-Cr-Mo alloy and has a sintered Co-Cr-Mo alloy bead porous surface coating. The modified device features a calcar region designed with 10 and 20mm build-up heights in both straight and bowed hip stems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head, hip, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Finite element analysis demonstrated that the device is equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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| NOV - 5 2003 | Summary of Safety and Effectiveness |
|---|---|
| Submitter: | Zimmer, Inc. |
| P.O. Box 708 | |
| Warsaw, IN 46581-0708 | |
| Contact Person: | Karen Cain |
| Manager, Regulatory Affairs | |
| Telephone: (574) 372-4219 | |
| Fax: (574) 372-4605 | |
| Date: | September 22, 2003 |
| Trade Name: | VerSys® Beaded FullCoat Calcar Hip Prosthesis |
| Common Name: | Hip prosthesis |
| Classification Name | |
| and Reference: | Hip joint metal/polymer/metal semi-constrained |
| porous-coated uncemented prosthesis | |
| 21 CFR § 888.3358 | |
| Predicate Device: | VerSys Beaded FullCoat Bowed Revision Hip |
| Prosthesis, manufactured by Zimmer, K030079, | |
| cleared February 5, 2003 | |
| Device Description: | Like its predicate, the VerSys Beaded FullCoat |
| Calcar Hip Prosthesis is a modular femoral stem | |
| manufactured from Co-Cr-Mo alloy and has a | |
| sintered Co-Cr-Mo alloy bead porous surface | |
| coating. The modified device features a calcar | |
| region designed with 10 and 20mm build-up heights | |
| in both straight and bowed hip stems. | |
| Intended Use: | The VerSys Beaded FullCoat Calcar Hip Prosthesis |
| is designed to achieve biologic fixation to bone and | |
| is indicated for: | |
| Total hip replacement for the following: severe hip | |
| pain and disability due to rheumatoid arthritis, | |
| osteoarthritis, traumatic arthritis, polyarthritis, | |
| collagen disorders, avascular necrosis of the | |
| femoral head, nonunion of previous fractures of the |
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| Ammer |
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femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability due to previous fusion, previously failed endoprostheses and/or total hip components in the affected extremity, and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip, elderly, debilitated patients when a total hip replacement is contraindicated, irreducible fractures in which adequate fixation cannot be obtained, certain high subcapital fractures and comminuted fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis in which the femoral head is primarily affected.
The modifications to the VerSys Beaded FullCoat Comparison to Predicate Device: Bowed Revision Hip Prosthesis do not change either the intended use or the fundamental scientific technology of the device. It is packaged and sterilized utilizing the same materials and processes. The modified device is designed to offer another revision style line extension to the existing system of implants.
Performance Data:
Finite element analysis demonstrated that the device is equivalent to the predicate.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes extending to the right.
Public Health Service
NOV = 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Cain Manager, Regulatory Affairs Zimmer. Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K033034
Trade/Device Name: Versys ® Beaded FullCoat Calcar Hip Prosthesis 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 Dated: September 26, 2003
Received: October 6, 2003
Dear Ms. Cain:
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 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. Karen Cain
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milkerson
Celia M. Witten, Ph.D., M.D. 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
Page 1 of 1
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510(k) Number (if known):
Device Name:
VerSys® Beaded FullCoat Calcar Hip Prosthesis
Indications for Use:
The VerSys Beaded FullCoat Calcar Hip Prosthesis is designed to achieve biologic fixation to bone and is indicated for:
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability due to previous fusion, previously failed endoprostheses and/or total hip components in the affected extremity, and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip, elderly, debilitated patients when a total hip replacement is contraindicated, irreducible fractures in which adequate fixation cannot be obtained, certain high subcapital fractures and comminuted fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis in which the femoral head is primarily affected.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K0 33034 |
|---|---|
| --------------- | ---------- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|