(142 days)
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Not Found
No
The document describes a ceramic femoral head, a mechanical implant, and makes no mention of AI, ML, image processing, or any software-driven functionality.
Yes
The device is intended to treat hip problems, including severely disabled joints, fractures, and failed hip replacements, which points to a therapeutic purpose.
No
The device is a ceramic femoral head, intended for use as an implant in total hip procedures to treat various hip problems. It is a treatment device, not one that identifies or analyzes medical conditions.
No
The device description explicitly states it is a "ceramic femoral head," which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Implex Alumina Femoral Head is a ceramic implant designed to be surgically placed inside the body to replace the femoral head in a hip joint.
- Intended Use: The intended use clearly describes its function as an articulating component in total hip procedures to address various hip conditions. This is a surgical implant, not a diagnostic test.
The information provided about the device's mechanical testing further supports that it's a physical implant and not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Implex Alumina Femoral Head is intended to provide articulation in total hip procedures in cases of:
-
- Severely disabled joints as a result of degenerative arthritis or avascular necrosis.
-
- Secondary revision of a previously unsuccessful femoral component or total hip replacement.
-
- Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results.
-
- Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.
-
- Non-Union of femoral neck or head fractures.
-
- Salvage of a failed primary or secondary total hip or hemi-hip arthroplasty.
Product codes
LZO
Device Description
The Implex Alumina Femoral Head is a ceramic femoral head. The Implex Alumina Femoral Head is offered in a 28 mm OD with +0, +3, and +6 neck offset lengths, and is intended for use with all legally Femoral Continuum Hip System marketed Components with a 12/14 locking taper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
hip
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical test data provided in this premarket notification demonstrates that the Alumina Femoral Head will perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
JUN 11 1999
K990183 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Implex Alumina Femoral Head
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce Drive |
| Allendale, New Jersey 07401-1600 | |
| Contact Person: | John Schalago or Robert Poggie |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 818-0567 |
| Date Prepared: | January 11, 1999 |
| Device Trade Name: | Implex Alumina Femoral Head |
| Device Common | |
| Name: | Ceramic femoral head |
| Classification Number | |
| and Name: | 21 CFR § 888.3353 |
Substantial Equivalence:
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of equivalence herein shall substantial be construed as an admission against interest under the US Patent Laws or their application by the courts.
- Device Description: The Implex Alumina Femoral Head is a ceramic femoral head. The Implex Alumina Femoral Head is offered in a 28 mm OD with +0, +3, and +6 neck offset lengths, and is intended for use with all legally Femoral Continuum Hip System marketed Components with a 12/14 locking taper.
1
Indications for Use:
The Implex Alumina Femoral Head is intended to provide articulation in total hip procedures in cases of:
- disabled joints as a result of 1. Severely degenerative arthritis or avascular necrosis.
-
- Secondary revision of a previously unsuccessful femoral component or total hip replacement.
-
- Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results.
-
- Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.
-
- Non-Union of femoral neck or head fractures.
-
- Salvage of a failed primary or secondary total hip or hemi-hip arthroplasty.
A comparison of device characteristics, materials, intended use and indications for use to commercially available ceramic femoral heads provided in this premarket notification support the determination that the Implex Alumina Femoral Head is substantially equivalent to legally marketed ceramic head components.
Mechanical test data provided in this premarket notification demonstrates that the Alumina Femoral Head will perform as intended.
The Implex Alumina Femoral Head is substantially equivalent to the identified predicate devices.
Device Technological Characteristics and Comparison to Predicate Device:
Performance Data:
Conclusion:
2
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 & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three overlapping, abstract shapes that resemble human figures or flowing forms. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 1999
Robert A. Poggie, Ph.D. Director of Applied Research Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600
K990183 Re : Implex Alumina Femoral Head Trade Name: Regulatory Class: II Product Code: LZO Dated: April 23, 1999 Received: April 26, 1999
Dear Dr. Pogqie:
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 Requlations, Title 21, Parts 800 to 895. ಕ 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 requlation 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.
3
Page 2 - Robert A. Poggie, Ph.D.
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 leqally 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 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
4
510 (k) Number (if known) :
Device Name:
Implex Alumina Femoral Head
Indications For Use:
The Implex Alumina Femoral Head is intended to provide articulation in total hip procedures in cases of:
-
- Severely disabled joints as a result of degenerative arthritis or avascular necrosis.
-
- Secondary revision of a previously unsuccessful femoral component or total hip replacement.
-
- Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results.
-
- Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.
-
- Non-Union of femoral neck or head fractures.
-
- Salvage of a failed primary or secondary total hip or hemi-hip arthroplasty.
(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 | K990183 |
| Prescription Use
| (Per 21 CFR 801.109) | Yes |
|---|---|
| ------------------------------------------ | ----- |
OR...
| Over-The-Counter Use | No |
|---|---|
| ---------------------- | ---- |
(Optional Format 1-2-96)
ﺮ ﻣﺘ
January 11, 1999