(43 days)
Not Found
Not Found
No
The description focuses on the material, design, and mechanical properties of a hip stem, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a hip stem intended for total hip arthroplasty, which is a surgical procedure to treat hip joint pathology, fitting the definition of a therapeutic device.
No
The device, the Implex Cobrex Hip Stem, is an implant used for hip replacement surgery due to severe degeneration, trauma, or other pathology. It is a treatment device, not designed to diagnose conditions.
No
The device description explicitly states it is a "modular femoral hip stem manufactured from forged cobalt chromium alloy," indicating it is a physical implant, 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Implex Cobrex Hip Stem is a surgical implant designed to replace a damaged hip joint. It is a physical device inserted into the body during surgery.
- Intended Use: The intended use clearly states it's for "cemented or hybrid total hip arthroplasty," which is a surgical procedure.
The description and intended use of the Implex Cobrex Hip Stem are consistent with a surgical implant, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Implex Cobrex Hip Stem is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented or hybrid total hip arthroplasty. The Cobrex Hip Stem is intended for cemented use with Continuum® Hip Stem Components only.
Product codes
JDI
Device Description
The Implex Cobrex Hip Stem, cemented, is a modular femoral hip stem manufactured from forged cobalt chromium alloy conforming to ASTM F-799. The Cobrex hip stem has a 12/14 taper and is available in five stem sizes (10, 11, 12, 13, and 14) with proportionally increasing neck offsets (24 mm, 30 mm, and 36 mm). Also, the Cobrex hip stem is collared with a cobra type flange on the proximal section.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Hip joint
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
Fatigue testing has been provided to demonstrate that the Cobrex hip stem will perform as intended.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the number '991869'. The characters are handwritten and slightly slanted to the right.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| 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: | May 28, 1999 |
| Device Trade Name: | Implex Cobrex Hip System, Femoral Component |
| Device Common Name: | Hip Prosthesis, Femoral Component Cemented or |
| Uncemented | |
| Classification Number | |
| and Name: | 21 CFR § 888.3360 |
| 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 substantial | |
| equivalence herein shall be construed as an | |
| admission against interest under the US Patent Laws | |
| or their application by the courts. | |
| Device Description: | The Implex Cobrex Hip Stem, cemented, is a modular |
| femoral hip stem manufactured from forged cobalt | |
| chromium alloy conforming to ASTM F-799. The Cobrex | |
| hip stem has a 12/14 taper and is available in five stem | |
| sizes (10, 11, 12, 13, and 14) with proportionally | |
| increasing neck offsets (24 mm, 30 mm, and 36 mm). | |
| Also, the Cobrex hip stem is collared with a cobra type | |
| flange on the proximal section. | |
| Indications for Use: | The Implex Cobrex Hip Stem is intended for use where |
| severe degeneration, trauma, or other pathology of the hip | |
| joint indicates cemented or hybrid total hip arthroplasty. | |
| Device Technological | |
| Characteristics and | |
| Comparison to | |
| Predicate Device: | A comparison of technological characteristics of the |
| subject and predicate devices supports a determination of | |
| substantial equivalence. | |
| Performance Data: | Fatigue testing has been provided to demonstrate that the |
| Cobrex hip stem will perform as intended. | |
| Conclusion: | The Implex Cobrex Hip Stem is substantially equivalent to |
| the identified predicate devices. |
The Cobrex Hip Stem is intended for cemented use with Continuum® Hip Stem Components only.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged around the caduceus in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 14 1999
Mr. John A Schalago Regulatory Affairs Manager Implex® Corp. 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K991869 Trade Name: Cobrex Hip Stem Regulatory Class: II Product Code: JDI Dated: May 28, 1999 Received: June 1, 1999
Dear Mr. Schalago:
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: 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.
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Page 2 - Mr. John A. Schalago
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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. Collin Wilcox, Ph.D., M.D.
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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| Cobrex Hip Stem |
|---|
| Implex Corp |
| 510(k) Number (if known): | K991869 |
|---|---|
| --------------------------- | --------- |
Device Name:
Cobrex Hip Stem
Indications For Use:
The Implex Cobrex Hip Stem is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented or hybrid total hip arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
OR...
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991869