(336 days)
The Meridian™ ST Femoral Stem and Vitalock® Solid Back Acetabular Shell with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum damaged as a result of non-inflammatory joint disease, avascular necrosis or trauma.
The Meridian® ST Femoral Stem and Vitalock® Solid Back Shell with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum damaged as a result of non-inflammatory joint disease, avascular necrosis or trauma. These devices are identical to the Meridian® ST femoral stem and Vitalock® Solid Back shell previously released under K94507, K930223, and K952397 respectively, except for a thin layer of hydroxyapatite coating applied to the porous coated surface.
The provided text describes a 510(k) premarket notification for the Meridian® ST Femoral Stem and Vitalock® Solid Back Shell with Peri-Apatite™ Coating. This document focuses on establishing substantial equivalence to previously marketed devices rather than presenting detailed performance studies with acceptance criteria in the way one might find for a new diagnostic or AI-powered device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not available in the provided text. The submission primarily relies on comparing the new device's intended use, materials, design, and operational principles to existing predicate devices.
Here's what the document does state about the assessment:
- Equivalence Basis: "This equivalence is based upon similarities in intended use, material, design, and operational principles to the legally marketed devices."
- Specific Testing Mentioned: "Testing to characterize the Peri-Apatite™ coating was presented, along with the results of an animal study."
- FDA's Determination and Limitations: The FDA's letter states, "The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only)." It explicitly prohibits claims for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." This indicates that while some testing was done (coating characterization, animal study), it was not sufficient to support efficacy claims beyond mechanical interlock, thus not meeting higher 'acceptance criteria' for biological performance.
Conclusion:
The provided text does not contain the specific information required to complete the table and answer the questions regarding acceptance criteria, study design, sample sizes, ground truth, experts, or MRMC studies. The 510(k) submission process outlined here is for demonstrating substantial equivalence based on fundamental device characteristics and existing predicate claims, not necessarily for proving novel performance metrics against pre-defined acceptance criteria in the manner an AI or diagnostic device would.
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510 (k) Summary
Meridian® ST Femoral Stem and Vitalock® Solid Back Device: with Peri-Apatite™ Coating Shell
Classification Name and Reference:
Hip Joint Metal/Polymer/Metal Semi-Constrained Porqus Coated Uncemented Prosthesis 21 CFR 888.3358
Proposed Regulatory Class: Class II (reclassified 1-8-93)
For information contact: Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard 07070 Rutherford, NJ Telephone: (201) 507-7431 (201) 507-6870 Fax:
The Meridian® ST Femoral Stem and Vitalock® Solid Back Shell with
are intended to be used in the primary Peri-Apatite™ Coating Ferringatice Coucing of the proximal femur and acetabulim damaged as a result of non-inflammatory joint disease, avascular necrosis or trauma. These devices are identical to the Meridian® ST femoral stem and Vitalock® Solid Back shell previously St remoral boom and v7 K930223, and K952397 respectively, released under x94507, are thin layer of hydroxyapatite coating applied to the porous coated surface.
The Meridian™ ST Femoral Stem and Vitalock® Solid Backed The Meridian "Di remoral "S-Apatite™ Coating are equivalent to other legally marketed devices in commercial distribution. These products are listed below:
- Meridian™ ST Femoral Stem Howmedica 1.
- Vitalock® Solid Backed Acetabular Shell Howmedica 2 .
- Osteolock™ HA Femoral Stem Howmedica 3.
This equivalence is based upon similarities in intended use, This aquivalence is based upon similaries in intended as ,
material, design, and operational principles to the legally
marketed devices.
Testing to characterize the Peri-Apatite™ coating was presented, along with the results of an animal study.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 11 1998
Ms. Margaret F. Crowe Group Manager, Regulatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey
K971206 Re: Meridan™ ST Femoral Stem and Vitalock® Solid Back Shell with Peri-Apatite Coating Regulatory Class: II Product Codes: LPH and MEH Dated: November 12, 1997 Received: November 13, 1997
Dear Ms. Crowe:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:
You may not label or in any way promote these devices for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional press-fit hipprosthesis (i.e., mechanical interlock, only).
Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.
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.
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Page 2 - Ms. Margaret F. Crowe
You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.
Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes 895. compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning vour device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
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Page 3 - Ms. Margaret F. Crowe
obtained from the Division of Small Manufacturers Assistance obtained from the biver (800) 638-2041 or (301) 443-6597 or at at fes corr rrec nambor (o:)/www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
a M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Meridian™ ST Femoral Stem and Vitalock® Solid Device Name: Back Acetabular Shell with Peri-Apatite™ Coating
Indications for Use:
The Meridian™ ST Femoral Stem and Vitalock® Solid Back Acetabular The Meridian - B - Cating are intended to be used in the primary uncemented reconstruction of the proximal femur and primary unceacheed as a result of non-inflammatory joint disease, avascular necrosis or trauma.
Prescription Use
(Per 21 CFR 801.109)
Piollifo
(Division Sign Off)
· Restorative Devices : 2971206 no, Vulmber __________________________________________________________________________________________________________________________________________________________________
§ 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.