(279 days)
The Zrconia Ceramic Modular Heads (Norton Advanced Ceramics) are indicated for use in Non-inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis, Rheumatoid Arthritis, correction of functional deformity, and revision of failed hip arthroplasty.
This device is a single use implant.
The Biomet ceramic modular head is designed to be the articular surface of an artificial hip joint. The highly polished spherical surface articulates with a polyethylene lined cup. The ball attaches to a metallic femoral stem. These heads are compatible with all of Biomet's hip stems with Type I tapers. This submission covers 28mm diameter heads with various neck offsets.
Biomet Zirconia Ceramic Modular Heads are manufactured from Yttria Stabilized Zirconia. Manufacturing of these ceramic devices will be done entirely outside Biomet by Norton Advanced Ceramics. Zirconia has been shown to possess superior wear qualities in comparison to all metals and even alumina ceramics. Mechanical testing was conducted with the final taper design in accordance with the FDA's guideline document. Devices were found to conform to all requirements including compression, pull-off and fatigue strength.
This document does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it is a premarket notification (510(k)) for a medical device: Zirconia Ceramic Modular Heads.
The provided text includes:
- A summary of safety and effectiveness information for the Zirconia Ceramic Modular Heads.
- A description of the device and its intended use.
- Potential risks associated with the device.
- A list of substantially equivalent devices.
- An FDA letter confirming substantial equivalence and outlining regulatory provisions.
- A form detailing the indications for use of the device.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone (algorithm-only) performance studies.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for a training set or how ground truth was established for a training set.
This document is focused on the regulatory approval process (510(k) clearance) for a new medical device based on its substantial equivalence to previously marketed devices, rather than a clinical or performance study with defined acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a bold, sans-serif font. The letters are outlined in black, and the word "INC" is stacked vertically on the right side of the logo with a registered trademark symbol.
AUG 1 1 1997
Corporate Headquarters
Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587
Shipping Address: Airport Industrial Park Warsaw. IN 46580
(219) 267-6639 Office 12191 267-8137 FAX
Summary of Safety and Effectiveness Information
Product; Zirconia Ceramic Modular Heads (Norton Advanced Ceramics)
Device Description: The Biomet ceramic modular head is designed to be the articular surface of an artificial hip joint. The highly polished spherical surface articulates with a polyethylene lined cup. The ball attaches to a metallic femoral stem. These heads are compatible with all of Biomet's hip stems with Type I tapers. This submission covers 28mm diameter heads with various neck offsets.
Biomet Zirconia Ceramic Modular Heads are manufactured from Yttria Stabilized Zirconia. Manufacturing of these ceramic devices will be done entirely outside Biomet by Norton Advanced Ceramics. Zirconia has been shown to possess superior wear qualities in comparison to all metals and even alumina ceramics. Mechanical testing was conducted with the final taper design in accordance with the FDA's guideline document. Devices were found to conform to all requirements including compression, pull-off and fatigue strength.
Potential Risks: The potential risks associated with this device are the same as with any hip replacement device. These include, but are not limited to:
Nerve Damage Blood Vessel Damage Cardiovascular Disorders Delayed Wound Healing Fatigue Fracture of Component Component Migration/Loosening Material Sensitivity Deformity of the Joint Muscle Laxity Soft Tissue Subluxation Dislocation
Bone Fracture Excessive Wear Infection Imbalance Hematoma
Substantially Equivalent Devices:
Zirconia Ceramic Heads (Type I Taper) (Biomet, Warsaw, IN) Zirconia Femoral Heads (Smith & Nephew Richards, Memphis, TN) Biolox® ALOg Ceramic Femoral Heads (Dow Corning Wright,Arlington, TN) Biolox® Al,O, Ceramic Femoral Heads (Smith and Nephew Richards, Memphis, TN) * Modular Ceramic Heads (DePuy, Warsaw, IN) Modular Ceramic Heads (Thackray, Orlando, FL) Modular Ceramic Heads (Protek, Indianapolis, IN)
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are black and have a flowing, abstract design. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres Director, Requlatory Affairs Biomet Inc.---------P.O. Box 587 Warsaw, Indiana 46581-0587
AUG 1 1 1997 --
Re: K96431 Zirconia Ceramic Modular Heads (Norton Advanced Ceramics) Requlatory Class: II Product Code: LZO Dated: June 24, 1997 Received: June 27, 1997
Dear Ms. Beres:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation that the package insert must reflect that the Zirconia Ceramic Modular Heads (Norton Advanced Ceramics) are to be used only with cobaltchrome-molybdenum and Ti6Al4V alloy hip stems with the Type I taper (4°0′, ±0°2′) trunnions.
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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set
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Page 2 - Ms. Patricia Sandborn Beres
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. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements as ma concerning your 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 Requlations.
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 regulation (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 obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
to collez
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): K964431
Device Name: Zirconia Ceramic Modular Heads (Norton Advanced Ceramics)
Indications For Use:
The Zrconia Ceramic Modular Heads (Norton Advanced Ceramics) are indicated for use in Non-inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis, Rheumatoid Arthritis, correction of functional deformity, and revision of failed hip arthroplasty.
This device is a single use implant.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use(Per 21 CFR 801.109) | X | Over-The-Counter Use |
| (Optional Format 1-2-96) | ||
| (Division Sign-Off)Division of General Restorative Devices | ||
| 510(k) Number | K964431 |
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.