(27 days)
Not Found
No
The document describes a mechanical hip prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device, a hip prosthesis, is designed to replace a damaged hip joint, which is a therapeutic intervention aimed at alleviating pain and restoring function.
No
Explanation: The device described is a hip prosthesis, which is an implant used for replacement surgery rather than for diagnosing a medical condition. Its intended use is to treat existing conditions, not to identify them.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The provided text describes a hip prosthesis, which is an implantable medical device used to replace a damaged hip joint. It is surgically implanted inside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, laboratory procedures, or diagnostic purposes related to analyzing bodily fluids or tissues.
Therefore, based on the provided information, the VerSys Beaded Hip Prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VerSys Beaded 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, protrusion 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 (comma separated list FDA assigned to the subject device)
LPH
Device Description
Like its predicate, the VerSys Beaded Fullcoat Bowed Revision 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 prosthesis features a 12/14 Morse-type proximal neck taper to mate with the corresponding 12/14 bore of a femoral head component. Proximal body geometry of the prosthesis is trapezoidal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, femoral
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The font is sans-serif and the color is black.
{ 06 Summary of Safety and Effectiveness
FEB 0 5 2003
C
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Fred McClure, RAC
Sr. Associate, Regulatory Affairs
Telephone: (574) 372-4294
Fax: (574) 372-4605 |
| Date: | January 8, 2003 |
| Trade Name: | VerSys ® Beaded Fullcoat Bowed Revision 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: | VerSys Hip System Beaded Hip Prosthesis,
manufactured by Zimmer, K973714, cleared
December 24, 1997 |
| Device Description: | Like its predicate, the VerSys Beaded Fullcoat
Bowed Revision 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 prosthesis features a 12/14
Morse-type proximal neck taper to mate with the
corresponding 12/14 bore of a femoral head
component. Proximal body geometry of the
prosthesis is trapezoidal. |
| Intended Use: | The VerSys ® Beaded 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, |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2003
Fred McClure, RAC Sr. Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K030079
Trade/Device Name: VerSys® Beaded Fullcoat Bowed Revision 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 8, 2003 Received: January 9, 2003
Dear Mr. McClure:
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
2
Page 2 – Mr. Fred McClure
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. 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) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
b. Mark M. Milliman
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
3
Indications for Use
Page 1 of 1
510(k) Number (if known):
030079
Device Name:
VerSys® Beaded Fullcoat Bowed Revision Hip Prosthesis
Indications for Use:
The VerSys Beaded 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, protrusion 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)
| for (Division Sign-Off) | |
|---|---|
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K030079 |
| Prescription Use (Per 21 CFR 801.109) | Yes |
| OR | |
| Over-The-Counter Use (Optional Format 1-2-96) No |