(29 days)
The VerSys Beaded MidCoat Low Head Center 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.
Like its predicate, the VerSys Beaded MidCoat Low Head Center Hip Prosthesis is a straight, 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.
This document is a 510(k) summary for the Zimmer VerSys R Beaded MidCoat Low Head Center Hip Prosthesis, which aims to demonstrate substantial equivalence to a predicate device. As such, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, expert ground truth, or comparative effectiveness with AI.
Instead, the document states that "Non-clinical performance testing demonstrated that the device is equivalent to the predicate." It focuses on showing that the new device's modifications do not change its intended use or fundamental scientific technology compared to the predicate device, the VerSys Hip System Beaded Hip Prosthesis (K973714).
Therefore, I cannot provide the requested information in the format specified because the provided text does not describe a study with acceptance criteria and a reported device performance in the way typically seen for AI/software devices. The submission is for a physical medical implant (hip prosthesis), and the "performance testing" referenced is likely mechanical and material testing to ensure equivalence, not a study involving human readers or AI.
Here's an attempt to address the points based on the available information, noting that many will be "Not Applicable" or "Not Provided" due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to predicate device for intended use and fundamental scientific technology. | Non-clinical performance testing demonstrated that the device is equivalent to the predicate. (Specific metrics not provided). Modifications change neither the intended use nor the fundamental scientific technology. |
| Materials and sterilization processes | Same as predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not provided. The testing mentioned is "non-clinical performance testing," which would typically involve physical samples of the prosthesis rather than a data test set.
- Data Provenance: Not applicable, as this refers to physical device testing, not a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for AI/software (expert labels on data) is not relevant for this type of device submission. The "ground truth" would be the established performance characteristics of the predicate device, determined through engineering and mechanical testing standards.
4. Adjudication method for the test set
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, this type of study is not relevant for a physical hip prosthesis.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
- Not explicitly stated, but for physical device equivalence, the ground truth would typically be established engineering specifications, mechanical test results (e.g., fatigue strength, wear resistance), and material property standards, all benchmarked against the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
In summary, the provided document is a 510(k) premarket notification for a physical medical device. It focuses on demonstrating "substantial equivalence" to a previously cleared predicate device through non-clinical performance testing, rather than presenting a performance study with detailed acceptance criteria and expert-labeled ground truth as would be expected for a software or AI medical device.
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| NOV - 4 2004 | Summary of Safety and Effectiveness |
|---|---|
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
| Contact Person: | Karen CainManager, Corporate Regulatory AffairsTelephone: (574) 372-4219Fax: (574) 372-4605 |
| Date: | October 5, 2004 |
| Trade Name: | VerSys R Beaded MidCoat Low Head Center HipProsthesis |
| Common Name: | Total hip prosthesis |
| Classification Nameand Reference: | Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis |
| 21 CFR § 888.3358 | |
| Predicate Device: | VerSys Hip System Beaded Hip Prosthesis,manufactured by Zimmer, K973714, clearedDecember 24, 1997 |
| Device Description: | Like its predicate, the VerSys Beaded MidCoat LowHead Center Hip Prosthesis is a straight, modularfemoral stem manufactured from Co-Cr-Mo alloyand has a sintered Co-Cr-Mo alloy bead poroussurface coating. The prosthesis features a 12/14Morse-type proximal neck taper to mate with thecorresponding 12/14 bore of a femoral headcomponent. Proximal body geometry of theprosthesis is trapezoidal. |
| Intended Use: | The VerSys Beaded MidCoat Low Head Center HipProsthesis is designed to achieve biologic fixationto bone and is indicated for: |
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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.
The modifications to the VerSvs Hip System Beaded Hip Prosthesis change neither the intended use nor the fundamental scientific technology of the device. Both devices are packaged and sterilized using the same materials and processes.
Non-clinical performance testing demonstrated that the device is equivalent to the predicate.
Comparison to Predicate Device:
Performance Data
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings.
NOV - 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Cain Manager, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581
Re: K042776
Trade/Device Name: VerSys® Beaded MidCoat Low Head Center Hip Prothesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prostheses. Regulatory Class: II Product Code: LPH Dated: October 5, 2004 Received: October 6, 2004
Dear Ms. Cain:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sumed in the encreated of the enactment date of the Medical Device Amendments, or to commerce pror to may 20, 17, in accordance with the provisions of the Federal Food, Drug, devices that have been recassion t require approval of a premarket approval application (PMA). and Oosmeter for ( 100 ) 100 ( 100 ) 100 ) 100 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 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 (240) 276-0120. 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,
Sincerely yours,
O Mark A. Mulkerson
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
510(k) Number (if known):
Device Name:
VerSys® Beaded MidCoat Low Head Center Hip Prosthesis
Indications for Use:
The VerSys Beaded MidCoat Low Head Center 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.
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)
Mark N. McSherry
- Restorative. Division of Gen and Neurological Devices
Page 1 of 1
510(k) Number K042776
§ 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.