(28 days)
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 femoral neck fractures in the aged; nonunion of femoral neck 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 Fiber Metal MidCoat Low Head Center Hip Prosthesis is a cementless, straight, modular femoral stem. The proposed and predicate devices are designed with trapezoidal geometry and feature 12/14 Morse-type proximal neck tapers to mate with the corresponding 12/14 bore of a femoral head component. Both devices feature 125-degree neck angles and distal, longitudinal splines. The modified device is manufactured from Tivanium Alloy and has circumferential, commercially-pure titanium fiber metal pads for biological fixation.
The provided text describes a Special 510(k) submission for a device modification, not a study proving a device meets acceptance criteria for an AI/ML-driven medical device. Therefore, much of the requested information regarding AI/ML device performance, ground truth, expert opinions, and training/test sets is not applicable to this document.
The document discusses the VerSys® Fiber Metal MidCoat Low Head Center Hip Prosthesis, a total hip prosthesis. The submission is for a modification to an existing cleared device (K042776).
Here's an analysis based on the provided text, highlighting what is and isn't available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Non-clinical performance testing demonstrated that the device is equivalent to the predicate." However, it does not provide a table of acceptance criteria or specific performance metrics. The "acceptance criteria" in this context would likely be related to mechanical properties, biocompatibility, and sterilization effectiveness – all of which are implicitly met through equivalence to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (Likely mechanical strength, fatigue, material properties, biocompatibility, sterilization effectiveness) | Non-clinical performance testing demonstrated equivalence to the predicate device (VerSys Beaded MidCoat Low Head Center Hip Prosthesis, K042776). |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable as this is a non-clinical device modification submission, not a study involving a test set of data (e.g., medical images). The "test set" in this context would refer to material samples or test specimens. The document doesn't specify the sample sizes for the non-clinical performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. "Ground truth" in this context would typically refer to expert consensus on medical findings for AI/ML evaluation. For a hip prosthesis, ground truth would be established through specific engineering standards, physical testing, and material science analysis rather than expert medical interpretation of images. The document does not mention any experts in this capacity.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple experts reviewing medical data, which is not relevant to this device modification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or prognostic devices to assess the impact of AI on human reader performance. This submission is for a physical medical device (hip prosthesis).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone performance evaluation (in the context of an algorithm) was not done. This is a hardware device.
7. The Type of Ground Truth Used:
For this device, the "ground truth" would be established by:
- Engineering standards and specifications: Defining the required mechanical properties, material composition, wear resistance, etc.
- Physical and mechanical testing: Including fatigue testing, static strength testing, and material characterization (e.g., tensile strength, hardness, surface roughness).
- Biocompatibility testing: As per ISO standards.
- Sterilization validation: Ensuring the device can be consistently sterilized.
The document states "Non-clinical performance testing demonstrated that the device is equivalent to the predicate," implying that these types of engineering and laboratory tests were performed and validated against established benchmarks for the predicate.
8. The Sample Size for the Training Set:
This information is not applicable as there is no "training set" in the context of an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" in the context of an AI/ML algorithm.
In summary, this document is a regulatory submission for a physical medical device modification, where "performance data" refers to non-clinical engineering and material equivalence testing, rather than a clinical study or AI/ML performance evaluation.
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Special 510(k): Device Modification
Image /page/0/Picture/1 description: The image contains the word "zimmer" next to a logo. The logo is a large letter "Z" inside of a circle. The word "zimmer" is in a smaller font than the "Z" in the logo. The text and logo are in black and white.
K0617-8Ca
Summary of Safety and Effectiveness
7/24/06
Submitter:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name and Reference:
Predicate Device:
Device Description:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Patricia Jenks Specialist, Regulatory Affairs Telephone: (574) 371-8354 Fax: (574) 372-4605
June 23, 2006
VerSys® Fiber Metal MidCoat Low Head Center Hip Prosthesis
Total Hip Prosthesis
Prosthesis, Hip, Semi-Constrained, Metal/Polymer Porous, Uncemented
21 CFR § 888.3358
VerSys Beaded MidCoat Low Head Center Hip Prosthesis, manufactured by Zimmer, K042776, cleared November 4, 2004
Like its predicate, the VerSys Fiber Metal MidCoat Low Head Center Hip Prosthesis is a cementless, straight, modular femoral stem. The proposed and predicate devices are designed with trapezoidal geometry and feature 12/14 Morse-type proximal neck tapers to mate with the corresponding 12/14 bore of a femoral head component. Both devices feature 125-degree neck angles and distal, longitudinal splines. The modified device is manufactured from Tivanium Alloy and has circumferential, commercially-pure titanium fiber
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Image /page/1/Picture/1 description: The image shows the Zimmer logo. The logo consists of a large, stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in a sans-serif font. The "Z" in the circle is black, and the word "zimmer" is also black.
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
metal pads for biological fixation.
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 femoral neck fractures in the aged; nonunion of femoral neck 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 Fiber Metal MidCoat Low Head Center Hip Prosthesis change neither the intended use nor the fundamental scientific technology of the device as compared to the predicate. The modified and unmodified device use the same materials and processes for packaging and sterilization.
Non-clinical performance testing 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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and a curved line representing its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. c/o Patricia Jenks Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
JUL 2 4 2006
Re: K061786
Trade/Device Name: VerSys® Fiber Metal MidCoat Low Head Center 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: June 23, 2006 Received: June 26, 2006
Dear Ms. Jenks:
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
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Page 2 - Ms. Patricia Jenks
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 (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/industry/support/index.html.
Sincerely yours,
Boutara Buekum
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K061786
Indications for Use
510(k) Number (if known):
Devicé Name:
VerSys® Fiber Metal MidCoat Low Head Center Hip Prosthesis
Indications for Use:
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, 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 femoral neck fractures in the aged; nonunion of femoral neck 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)
(hithie Guchand
(Division Sign-Of Division of General, Restorative, and Neurological Besters
Page 1 of 1
510(k) Number K111786
§ 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.