(19 days)
The Osteonics® Alumina C-Taper Heads are single-use devices and may be used with all appropriately selected, legally marketed Osteonics Ti6A14V alloy femoral stems that incorporate a C-Taper trunnion. Additionally, the Osteonics® 36mm Alumina C-Taper Head is intended for use with any appropriately selected Osteonics® Trident™ Polyethylene Inserts and associated Trident™ Acetabular Shell.
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
Osteonics® Alumina C-Taper Heads are alumina ceramic femoral bearings that have been designed for assembly, through a taper lock mechanism, to Ti6A14V alloy stems with the Osteonics® C-Taper trunnion design. This line extension to The Osteonics® Alumina C-Taper Heads adds the 36mm diameter size, with neck extensions of +0mm and +5mm. The subject heads are identical in material and design to the predicate heads.
Osteonics® Trident™ Polyethylene Inserts are manufactured from UHMWPE. They are compatible with Trident™ design Acetabular Shells. The subject inserts have an inner diameter of 36mm in order to mate with the subject 36mm alumina head.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for a medical device (Osteonics® Alumina C-Taper Heads and Osteonics® Trident™ Polyethylene Inserts) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting performance data against specific acceptance criteria.
Therefore, I cannot provide the requested information.
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JUN 29 1999
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Image /page/0/Picture/2 description: The image shows a handwritten string of characters, which appears to be 'K991952'. The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with some characters slightly tilted or curved.
510(k) Summary
Special 510(k) - Line Extension Summary of Safety and Effectiveness for the Osteonics® Alumina C-Taper Heads and Osteonics® Trident™ Polyethylene Inserts
Submission Information
Contact Person:
ું
Name and Address of the Sponsor Howmedica Osteonics Corp. of the 510(k) Submission: 59 Route 17 Allendale, NJ 07401-1677
Marybeth Naughton Regulatory Affairs Team Member
June 9, 1999
Device Identification
Proprietary Name:
Date of Summary Preparation:
Common Name:
Classification Name and Reference:
Osteonics® Alumina C-Taper Head Osteonics® Trident™ Polyethylene Inserts
Ceramic Femoral Bearing Acetabular Insert
Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented or Nonporous Uncemented Prosthesis 21 CFR §888.3353/888.3358
Predicate Device Identification
The Osteonics® 36mm Alumina C-Taper Head and mating Osteonics® Trident™ Polyethylene Insert is substantially equivalent to the following Howmedica Osteonics devices, which have previously been determined substantially equivalent by FDA:
- Osteonics® Alumina C-Taper Heads ●
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- Osteonics® Trident Polyethylene Inserts (Osteonics® Generation II Cup Inserts) ●
Device Description
Osteonics® Alumina C-Taper Heads are alumina ceramic femoral bearings that have been designed for assembly, through a taper lock mechanism, to Ti6A14V alloy stems with the Osteonics® C-Taper trunnion design. This line extension to The Osteonics® Alumina C-Taper Heads adds the 36mm diameter size, with neck extensions of +0mm and +5mm. The subject heads are identical in material and design to the predicate heads.
Osteonics® Trident™ Polyethylene Inserts are manufactured from UHMWPE. They are compatible with Trident™ design Acetabular Shells. The subject inserts have an inner diameter of 36mm in order to mate with the subject 36mm alumina head.
Intended Use:
The Osteonics® Alumina C-Taper Heads are single-use devices and may be used with all appropriately selected, legally marketed Osteonics Ti6A14V alloy femoral stems that incorporate a C-Taper trunnion. Additionally, the Osteonics® 36mm Alumina C-Taper Head is intended for use with any appropriately selected Osteonics® Trident™ Polyethylene Inserts and associated Trident™ Acetabular Shell.
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
Statement of Technological Comparison:
The substantial equivalence of the line extension for Osteonics® Alumina C-Taper Heads and the Osteonics® Trident™ Polyethylene Inserts to the predicate devices identified above-is based on equivalence in intended use, materials, design, indications and contraindications to the Osteonics® Alumina C-Taper Heads (K971409) and the Osteonics® Trident™ Polyethylene Inserts (Osteonics® Generation II Cup Inserts; K983382, K983502).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 29 1999
Ms. Elizabeth A. Staub Vice President, Quality Assurance Regulatory Compliance Clinical Research Stryker Howmedica Osteonics 59 Route 17 Allendale, New Jersey 07401
Re: K991952
Trade Name: Line Extension, Osteonics® Alumina C-Taper Heads, Osteonics® Trident™ Polyethylene Inserts
Regulatory Class: II Product Code: LZO Dated: June 9, 1999 Received: June 10, 1999
Dear Ms. Staub:
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. 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 regulations 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 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 concerning your device in the Federal Register. Please note:
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Page 2 – Ms. Elizabeth Staub
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. 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 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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Kタク/ダブレ
Device Name: Line Extension - Osteonics® Alumina C-Taper Head, Osteonics® Trident™ Polvethylene Inserts
Indications For Use:
The indications for the use of these ceramic bearing heads and polyethylene inserts are in keeping with those of other legally marketed Osteonics ceramic bearing heads and polyethylene inserts are as follows:
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previously failed cup arthroplasty or other procedure. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques . as indicated by deficiencies in the acetabulum.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use No
(Optional Format 1-2-96)
b. Ostell
1991952
§ 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.