(244 days)
Not Found
Not Found
No
The description focuses on the mechanical components and materials of a hip implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to treat painful, disabling joint disease of the hip, which is a therapeutic purpose.
No
The device is an acetabular cage system, which is an implant used for hip replacement surgery. Its intended use is to treat painful, disabling joint disease of the hip and revise previous unsuccessful procedures. This describes a therapeutic, not a diagnostic, function.
No
The device description clearly describes a physical implantable medical device (acetabular cage and cup) made of materials and available in various sizes, which is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for treating painful hip joint diseases and revising previous hip procedures. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is an acetabular cage and cup system, which are physical implants designed to replace or support the hip joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an in vivo surgical implant.
N/A
Intended Use / Indications for Use
The indications for use of the Implex Hedrocel®Acetabular Cage are as follows:
• For cemented or cementless use.
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI
Device Description
The Hedrocel® Acetabular Cage System consists of the Hedrocel® Acetabular Cage configured with an Implex All-Poly Cup. The Hedrocel® Acetabular Cage System, cemented and cementless, is available in OD sizes from 52 mm to 70 mm in 2 mm increments. The Hedrocel Acetabular Cage (Shell) is compatible with All-Poly Cups in OD sizes from 40 mm to 58 mm. The All-Poly Cups, cemented, are available with four ID size options (22 mm, 26 mm, 28 mm and 32 mm) and in 0° and 10° face angles. The All-Poly Cup is affixed to the Hedrocel® Acetabular Cage using acrylic bone cement.
The Hedrocel® Acetabular Cage may be used with Continuum Hip Bone Screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing conducted on the commercially available devices comprised wholly or in part of Hedrocel® and the Hedrocel Acetabular Cage System indicate that the device will function as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS The Implex Hedrocel® Acetabular Cage System
| Submitter Name: | Implex Corp. | K983831 |
|---|---|---|
| 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: | June 17, 1999 | |
| Device Trade Name: | The Implex Hedrocel® Acetabular Cage System | |
| Device Common Name: | Acetabular Reconstructive Cage | |
| Classification Number : | 21 CFR § 888.3350 |
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 device can be marketed without which a or reclassification. premarket approval (1) 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 Hedrocel® Acetabular Cage System consists of the Hedrocel® Acetabular Cage configured with an Implex All-Poly Cup. The Hedrocel® Acetabular Cage System, cemented and cementless, is available in OD sizes from 52 mm to 70 mm in 2 mm increments. The Hedrocel Acetabular Cage (Shell) is compatible with All-Poly Cups in OD sizes from 40 mm to 58 mm. The All-Poly Cups, cemented, are available with four ID size options (22 mm, 26 mm, 28 mm and 32 mm) and in 0° and 10° face angles. The All-Poly Cup is affixed to the Hedrocel® Acetabular Cage using acrylic bone cement.
The Hedrocel® Acetabular Cage may be used with Continuum Hip Bone Screws.
1
.
| Indications for Use: | The indications for use of the Implex Hedrocel®
Acetabular Cage are as follows:
• For cemented or cementless use.
• Painful, disabling joint disease of the hip
resulting from: degenerative arthritis,
rheumatoid arthritis or late stage avascular
necrosis.
• Revision of previous unsuccessful femoral
head replacement, cup arthroplasty or other
procedure.
• Clinical management problems where
arthrodesis or alternative reconstructive
techniques are less likely to achieve
satisfactory results.
• Where bone stock is of poor quality or is
inadequate for other reconstructive
techniques as indicated by deficiencies of
the acetabulum. |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Technological
Characteristics and
Comparison to
Predicate Device: | A comparison of technical characteristics included in
this 510(k) Premarket notification demonstrates that
the Hedrocel® Acetabular Cage System is
substantially equivalent to commercially available
reconstructive devices. |
| Performance Data: | Testing conducted on the commercially available
devices comprised wholly or in part of Hedrocel® and
the Hedrocel Acetabular Cage System indicate that
the device will function as intended. |
| Conclusion: | The Implex Hedrocel® Acetabular Cage is
substantially equivalent to the identified predicate
devices. |
:
:
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
John A. Schalago, RAC Manager of Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401
Re: K983837
Implex Hedrocel® Acetabular Cage System for Cemented or Cementless Fixation Regulatory Class: II Product Code: LPH and JDI Dated: April 21, 1999 Received: April 22, 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 (OS) 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.
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.
3
Page 2- Mr. John Schalago
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
P. Cotter
- 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:
The Hedrocel® Acetabular Cage System
Indications For Use:
The indications for use of the Implex Hedrocel® Acetabular Cage are as follows:
- For cemented or cementless use. .
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty ● or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive . techniques as indicated by deficiencies of the acetabulum.
(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 | K983835 |
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
OR...
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)