(84 days)
Osteonics® Omnifit® Ceramic Morse Taper Head, Osteonics® Zirconia C-Taper Femoral Bearing Head
Not Found
No
The device description focuses on the material and mechanical design of a hip replacement component, with no mention of software, algorithms, or data processing.
Yes.
This device is an artificial joint, intended to replace damaged parts of the hip, thereby treating painful and disabling joint diseases.
No
The document describes a bone implant device (femoral head for hip replacement) and its intended uses, not a device used for diagnosing a medical condition.
No
The device description clearly describes a physical, implantable medical device made of alumina ceramic, designed for assembly with femoral stems and acetabular components in hip replacement surgery. It does not mention any software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a component of a hip replacement system, used for treating various conditions affecting the hip joint. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical characteristics and materials of a femoral head component for hip arthroplasty. It does not mention any reagents, calibrators, controls, or other elements typically associated with IVD devices.
- Lack of IVD-related terms: The text does not contain any terms or concepts related to in vitro testing, laboratory procedures, or analysis of biological samples.
Therefore, the Osteonics Alumina C-Taper Heads are a surgical implant and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Osteonics Alumina C-Taper Heads are single-use devices and may be used with all appropriately selected, legally marketed Osteonics Ti6Al4V femoral stems that incorporate a C-Taper trunnion. Additionally, the Osteonics® Alumina C-Taper Head is intended for use with any appropriately selected, legally marketed Osteonics polyethylene acetabular cup liner and associated metal shell, bipolar or Osteonics all-polyethylene acetabular cup.
For use as a Bipolar Hip Replacement:
- Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular procedure and in avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
For Use as a Total Hip Replacement:
- 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO
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. The Osteonics Alumina C-Taper Heads are available in 28mm diameter and 32mm diameter sizes, and in neck extensions of +0mm and +5mm.
The Osteonics" Alumina C-Taper Heads are characterized by the following features:
- A basic spherical design.
- A smooth exterior finish.
- An interior geometry which accommodates any Osteonics stem with a C-Taper trunnion.
These heads differ from the predicate Osteonics C-Taper Zirconia Ceramic Heads in that they feature alumina instead of zirconia ceramic; however both heads incorporate the identical C-Taper bore design. If the titanium adaptor sleeve of the Osteonics" Alumina Ceramic Bearing Head were excluded, the subject head would be identical in design and material to the predicate head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Osteonics® Omnifit® Ceramic Morse Taper Head, Osteonics® Zirconia C-Taper Femoral Bearing Head
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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JUL - 9 1997
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics" Alumina C-Taper Head
Submission Information
Name and Address of the Sponsor
| of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
|------------------------------|------------------------------------------------------------------|
| Contact Person: | Kate Sutton
Regulatory Affairs Specialist |
| Date of Summary Preparation: | April 15, 1997 |
| Device Identification | |
| Proprietary Name: | Osteonics Alumina C-Taper Head |
| Common Name: | Ceramic Femoral Bearing |
Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented or Nonporous Uncemented Prosthesis 21 CFR §888.3353
Predicate Device Identification
The Osteonics Alumina C-Taper Head is substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:
-
Osteonics® Omnifit® Ceramic Morse Taper Head
Classification Name and Reference: -
Osteonics® Zirconia C-Taper Femoral Bearing Head
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
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C-Taper trunnion design. The Osteonics Alumina C-Taper Heads are available in 28mm diameter and 32mm diameter sizes, and in neck extensions of +0mm and +5mm.
The Osteonics" Alumina C-Taper Heads are characterized by the following features:
- A basic spherical design. .
- . A smooth exterior finish.
- An interior geometry which accommodates any Osteonics stem with a C-Taper trunnion. .
These heads differ from the predicate Osteonics C-Taper Zirconia Ceramic Heads in that they feature alumina instead of zirconia ceramic; however both heads incorporate the identical C-Taper bore design. If the titanium adaptor sleeve of the Osteonics" Alumina Ceramic Bearing Head were excluded, the subject head would be identical in design and material to the predicate head.
Intended Use:
The Osteonics Alumina C-Taper Heads are single-use devices and may be used with all appropriately selected, legally marketed Osteonics Ti6Al4V femoral stems that incorporate a C-Taper trunnion. Additionally, the Osteonics® Alumina C-Taper Head is intended for use with any appropriately selected, legally marketed Osteonics polyethylene acetabular cup liner and associated metal shell, bipolar or Osteonics all-polyethylene acetabular cup.
Indications:
For use as a Bipolar Hip Replacement:
The indications for the use of the Osteonics" Alumina C-Taper Head, in keeping with those of other legally marketed Osteonics ceramic bearings, are as follows:
For Use as a Bipolar Hip Replacement:
- . Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular . involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative . acetabular procedure and in avoidance of the use of bone cement in the acetabulum.
● Salvage of failed total hip arthroplasty.
For Use as a Total Hip Replacement:
- 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.
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Statement of Technological Comparison:
The substantial equivalence of the Osteonics Alumina C-Taper Heads to the predicate devices identified above-in terms of intended use, materials, and design features-is based on the following.
Intended Uses:
The Osteonics Alumina C-Taper Head, like the predicate Osteonics C-Taper Zirconia Ceramic Heads cited above, is intended for use with any appropriately selected, legally marketed Osteonics polyethylene acetabular cup liner or any Osteonics all-polyethylene acetabular cup.
Materials:
The Osteonics" Alumina C-Taper Head and the predicate Osteonics" Alumina Ceramic Bearing Head and Titanium Adaptor Sleeve Assembly cited above are manufactured from the same materials, exclusive of the titanium adaptor sleeve. Both devices are fabricated from high density, high purity, fine grain Aluminum Oxide (Al2O2) ceramic (ASTM F-603).
Design:
।
The design of the Osteonics Alumina C-Taper Head is consistent with that of the predicate Osteonics" Alumina Ceramic Bearing Head and Titanium Adaptor Sleeve Assembly and differs only in the following:
-
The Osteonics" Alumina C-Taper does not have a titanium adaptor sleeve.
The design of the Osteonics Alumina C-Taper Head is consistent with that of the predicate Osteonics C-Taper Zirconia Ceramic Head and differs only in the following: -
The subject device is fabricated from alumina ceramic, whereas the predicate device is fabricated from zirconia ceramic.
None of these design or material differences raise any new questions of safety or effectiveness.
Summary
Based on the similarities presented above, the supporting testing summary, the pre-clinical data incorporated by reference to prior submissions, and the fact that the Osteonics" Alumina C-Taper Heads employ standard sterilization and packaging methods, the substantial equivalence of the Osteonics Alumina C-Taper Heads to other legally marketed, class II, acetabeler Femoral head components is demonstrated.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kate Sutton Requlatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
JUL - 9 1997
Re : K971409 Osteonics® Alumina C-Taper Head Regulatory Class: II Product Code: LZO Dated: April 15, 1997 Received: April 16, 1997
Dear Ms. Sutton:
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 Osteonics® Alumina C-Taper Heads are to be used only with Ti6Al4V alloy hip stems with the C-Taper trunnion design.
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. Kate Sutton
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 Requlations, 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 requlation (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 In addition, FDA may publish further announcements action. 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 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 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
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Page 3 - Ms. Kate Sutton
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,
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): K971409
Device Name: Osteonics" Alumina C-Taper Head
Indications For Use:
The indications for the use of these ceramic bearings, in keeping with those of other legally marketed Osteonics ceramic bearings, are as follows:
For Use as a Bipolar Hip Replacement:
- Femoral head/neck fractures or non-unions. .
- . Aseptic necrosis of the femoral head.
- . Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative ● acetabular procedure and in avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty. .
For Use as a Total Hip Replacement:
- 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division/Sign-Off) | ||
| Division of General Restorative Devices | ||
| 510(k) Number | K971409 | |
| Prescription Use X | OR | Over-The-Counter Use ____ |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |