(86 days)
Implex Hedrocel® Porous Acetabular Cup System, Implex Replacement Acetabular Cup Insert System, Osteonics GAP II Restoration Acetabular shell with Omnifit® Polyethylene Insert Bearing.
Not Found
No
The summary describes a physical medical device (a replacement cup insert) and its intended use and compatibility. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is described as an "in-situ replacement polyethylene bearing surface" for joint instability, wear, and/or damage, indicating its use to treat a medical condition.
No
Explanation: The device is an orthopedic implant (replacement cup insert) used for treatment, specifically to provide a new bearing surface in a joint. It does not perform any diagnostic function.
No
The device description clearly indicates a physical implant (polyethylene bearing surface) intended for surgical use, not a software application.
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 and Intended Use: The provided text describes a physical implantable device – a replacement cup insert for a hip joint. It is intended to be surgically implanted inside the patient's body to address issues with the existing joint.
The device's function is mechanical and structural, not diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Implex Hedrocel® Replacement Cup Insert, cemented, is intended for use as a in-situ replacement polyethylene bearing surface under circumstances of joint instability, wear and/or damage caused by the patient during use.
Product codes
JDI
Device Description
The Implex Hedrocel® Replacement Cup Inserts, cemented, are compatible with the family of Hedrocel® acetabular cups in OD sizes from 40 to 70 mm. The replacement inserts are available with four ID size options (22 mm, 26 mm, 28 mm and 32 mm) and in 0°, 10°, and 20° face angles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Testing conducted to evaluate the fatigue characteristics of the device under defined laboratory conditions was provided to support a finding of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Implex Hedrocel® Porous Acetabular Cup System, Implex Replacement Acetabular Cup Insert System, Osteonics GAP II Restoration Acetabular shell with Omnifit® Polyethylene Insert Bearing.
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
·
:
K983128
IMPLEX Hedrocel® Replacement Cup Insert, Cemented
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce Drive |
| Allendale, New Jersey 07401-1600 | |
| Contact Person: | Robert Poggie, PhD or John Schalago, RAC |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 818-0567 |
| Date Prepared: | September 3, 1998 |
| Device Trade Name: | Implex Hedrocel® Replacement Cup Insert |
| Device Common Name: | Acetabular Cup |
| Classification Name: | Prosthesis, Hip, Acetabular Component, Cemented |
| Predicate Devices: | Implex Hedrocel® Porous Acetabular Cup System, Implex |
| Replacement Acetabular Cup Insert System, Osteonics GAP II | |
| Restoration Acetabular shell with Omnifit® Polyethylene Insert | |
| Bearing. | |
| Device Description: | The Implex Hedrocel® Replacement Cup Inserts, cemented, are |
| compatible with the family of Hedrocel® acetabular cups in OD | |
| sizes from 40 to 70 mm. The replacement inserts are available | |
| with four ID size options (22 mm, 26 mm, 28 mm and 32 mm) | |
| and in 0°, 10°, and 20° face angles. | |
| Intended Use: | The Implex Hedrocel® Replacement Cup Insert, cemented, is |
| intended for use as a in-situ replacement polyethylene bearing | |
| surface under circumstances of joint instability, wear and/or | |
| damage caused by the patient during use. | |
| Device Technological | |
| Characteristics and | |
| Comparison to | |
| Predicate Device: | A comparison of the principal device technological |
| characteristics to the predicate devices demonstrates that the | |
| bearing surface is substantially equivalent to commercially | |
| available polyethylene bearing surfaces | |
| Performance Data: | Testing conducted to evaluate the fatigue characteristics of |
| the device under defined laboratory conditions was | |
| provided to support a finding of substantial equivalence. | |
| Conclusion: | The Implex Hedrocel® Replacement Cup Insert is |
| substantially equivalent to the identified predicate devices. |
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and the comments of the comments of
11:10 PM
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Image /page/2/Picture/10 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is a stylized image of three human profiles facing right, with flowing lines representing movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 1998
John A. Schalago, RAC Regulatory Affairs Manager Implex Corporation 80 Commerce Drive 07401-1600 Allendale, New Jersey
K983128 Re: Implex Hedrocel® Replacement Cup Insert Trade Name: Requlatory Class: II Product Code: JDI Dated: September 4, 1998 Received: September 8, 1998
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 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 requlations 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 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.
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Page 2 - John A. Schalago, RAC
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 requlation (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
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):
Device Name:
Implex Hedrocel® Replacement Cup Insert
Indications For Use:
The Implex Hedrocel® Replacement Cup Insert, cemented, is intended for use as an in-situ replacement polyethylene bearing surface under circumstances of joint instability, wear and/or damage caused by the patient during use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
OR...
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
| (Optional Format 1-2-96) | |
|---|---|
| -------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K983128 |
Concurrence of CDRH; Office of Device Evaluation (ODE)