(80 days)
Not Found
No
The summary describes a mechanical implant for hip replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is an acetabular cup for total hip arthroplasty, which is a medical procedure to treat severe degeneration, trauma, or pathology of the hip joint. This procedure aims to restore function and alleviate symptoms, thus serving a therapeutic purpose.
No
The device is an acetabular cup designed for hip arthroplasty, which is a treatment or replacement procedure, not a diagnostic one. Its description focuses on surgical use and physical testing, with no mention of detecting or analyzing medical conditions.
No
The device description clearly indicates a physical implant (Acetabular Cup) and associated hardware (screws, dome hole plug). The performance studies also focus on mechanical testing of the physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "cemented, cementless or hybrid total hip arthroplasty," which is a surgical procedure involving the hip joint. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical implant (an acetabular cup) and associated components (screws, plug) designed to be surgically implanted. This is not consistent with the nature of an IVD.
- Anatomical Site: The device is intended for the "hip joint," an internal anatomical site. IVDs work with samples taken from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Using reagents or analytical instruments for testing.
This device is a surgical implant used in orthopedic surgery.
N/A
Intended Use / Indications for Use
The Implex Modular Elliptical Porous Acetabular Cup is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless or hybrid total hip arthroplasty.
Product codes
LPH, JDI
Device Description
The Implex Modular Elliptical Porous Acetabular Cup is intended for use with 6.5 mm diameter cancellous bone screws in 20 to 65 mm lengths, in 5 mm increments. A titanium alloy dome hole plug is available for sealing the central dome hole.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Push-out, lever-out, and torsion testing per applicable FDA Guidance Documents and ASTM Standards (or draft standards) of the insert liner and shell assembly showed that the subject device possesses performance characteristics similar to several legally marketed devices.
Key Metrics
Not Found
Predicate Device(s)
The Implex Elliptical Porous Acetabular Cup System (non-modular). The Biomet Ringloc Acetabular Cup System. The DePuy Duraloc Acetabular Cup System.
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS OCT 8 1999
The Implex Modular Elliptical Porous Acetabular Cup
| 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) 995-9722 |
| Date Prepared: | July 19, 1999 |
| Device Trade Name: | The Implex Modular Elliptical Porous Acetabular Cup |
| Device Common | |
| Name: | Acetabular Cup |
| Classification Number | |
| and Name: | 21 CFR § 888.3358 |
| 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. |
1
.
| Device Description
| (cont'd): | 510(k) Summary (Continued) | ||
|---|---|---|---|
| The Implex Modular Elliptical Porous Acetabular Cup is intended for use with 6.5 mm diameter cancellous bone screws in 20 to 65 mm lengths, in 5 mm increments. A titanium alloy dome hole plug is available for sealing the central dome hole. | |||
| Indications for Use: | The Implex Modular Elliptical Porous Acetabular Cup is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless or hybrid total hip arthroplasty. | ||
| Predicate Devices: | The Implex Elliptical Porous Acetabular Cup System (non-modular). The Biomet Ringloc Acetabular Cup System. The DePuy Duraloc Acetabular Cup System. | ||
| Device Technological | |||
| Characteristics and | |||
| Comparison to | |||
| Predicate Device: | The subject device and the predicate devices are manufactured from similar materials, have similar insert locking mechanisms, have similar or the same indications for use, and utilize similar surgical techniques and instrumentation. | ||
| Performance Data: | Push-out, lever-out, and torsion testing per applicable FDA Guidance Documents and ASTM Standards (or draft standards) of the insert liner and shell assembly showed that the subject device possesses performance characteristics similar to several legally marketed devices. | ||
| Conclusion: | The Implex Modular Elliptical Porous Acetabular Cup is substantially equivalent to the identified predicate devices. |
:
:
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 OCT
Mr. John A. Schalago, RAC Manager, Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale. New Jersey 07401-1600
Re: K992409
Trade Name: The Implex Modular Elliptical Porous Acetabular Cup Regulatory Class: II Product Code: LPH, JDI Dated: July 19, 1999 Received: July 20, 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 Ouality 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) 594-4595. 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
Implex Corp
510(k) Number (if known) :
K 992409
Device Name:
The Implex Modular Elliptical Porous Acetabular Cup
Indications For Use:
The Implex Modular Elliptical Porous Acetabular Cup is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless 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)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992409 |
| Prescription Use (Per 21 CFR 801.109) | Yes |
|---|---|
| --------------------------------------- | ----- |
OR...
| Over-The-Counter Use | No |
|---|---|
| ---------------------- | ---- |
(Optional Format 1-2-96)