(64 days)
Not Found
No
The summary describes a physical medical device (acetabular cups) and its intended use and instrumentation. There is no mention of software, algorithms, image processing, AI, ML, or performance studies related to such technologies.
Yes
The device is a medical implant intended to treat severe degeneration, trauma, or other pathology of the hip joint, which aligns with the definition of a therapeutic device.
No
This device is described as an acetabular cup for total hip arthroplasty, which is a prosthetic implant used for treatment, not for diagnosing a condition.
No
The device description clearly indicates a physical implant (acetabular revision cups) and associated instrumentation, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip arthroplasty, which is a medical procedure performed in vivo (within the body).
- Device Description: The description details a physical implant (acetabular cups) used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens in vitro (outside the body) to diagnose diseases or conditions.
Therefore, the Implex HEP Acetabular Revision Cups are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless, or hybrid total hip arthroplasty. This device is intended for either cementless or cemented use.
Product codes
JDI, LPH
Device Description
Implex HEP Acetabular Revision Cups, Cemented or Cementless, are available in OD sizes from 40 mm to 72 mm (in 2 mm increments), and with 4 possible ID size options (22 mm, 26 mm, 28 mm, and 32 mm). Implex HEP Revision Acetabular Cups are to be implanted using the Implex Acetabular Cup Instrumentation System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, acetabulum
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Implex HEP Porous Acetabular Cup System, Cemented and Cementless; Implex Porous Elliptical Revision Cup System, Cemented and Cementless, Implex Acetabular Cup Screw 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
APR | 4 |998
K98 0486
: 1
510(k) SUMMARY - IMPLEX HEP Acetabular Cup Revision System, Cemented or
Cementess
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce Drive |
| Allendale, New Jersey 07401-1600 | |
| Contact Person(s): | Robert Poggie or Robert Cohen |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 818-0567 |
| Date Prepared: | February 6, 1998 |
| Device Trade Name: | Implex HEP Acetabular Revision Cup, Cemented or |
| Cementless | |
| Device Common Name: | Acetabular Cup |
| Classification Name: | Prosthesis, Hip, Acetabular Component, Cemented, |
| Cementless | |
| Predicate Devices: | Implex HEP Porous Acetabular Cup System, Cemented and |
| Cementless; Implex Porous Elliptical Revision Cup System, | |
| Cemented and Cementless, Implex Acetabular Cup Screw | |
| System. | |
| Device Description: | Implex HEP Acetabular Revision Cups, Cemented or |
| Cementless, are available in OD sizes from 40 mm to 72 mm | |
| (in 2 mm increments), and with 4 possible ID size options (22 | |
| mm, 26 mm, 28 mm, and 32 mm). Implex HEP Revision | |
| Acetabular Cups are to be implanted using the Implex | |
| Acetabular Cup Instrumentation System. | |
| Intended Use: | For use where severe degeneration, trauma, or other |
| pathology of the hip joint indicates cemented, cementless, or | |
| hybrid total hip arthroplasty. This device is intended for | |
| either cementless or cemented use |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 1998
Robert A. Poggie, Ph.D. Director of Applied Research Implex Corporation 80 commerce Drive 07401-1600 Allendale, New Jersey
K980486 Re: Implex HEP Acetabular Revision Cup Trade Name: Requlatory Class: II Product Codes: JDI and LPH February 6, 1998 Dated: February 9, 1998 Received:
Dear Dr. Poggie:
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 The general controls provisions of the Act 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. ਸਿ 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 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.
2
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 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,
Stephen Ruerlus
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
3
13980486
510(k) Number (if known):
Device Name:
Implex HEP Acetabular Revision Cup
Indications For Use:
Intended for use in the acetabulum 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)
Prescription Use
(Per 21 CFR 801.109) yes
OR...
Steptre le
(Division Sign-Off)
Over-The-Counter Use No
(Optional Format 1-2-96)