(223 days)
Not Found
Not Found
No
The summary describes a physical medical device (acetabular cup system) and its intended use and physical characteristics. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device, an acetabular cup system, is used to replace damaged hip joints and address various hip problems, fitting the definition of a therapeutic device designed to treat a medical condition.
No
The provided text describes the Implex A-240 HEP Acetabular Cup System as an implant used for total hip replacement and other hip problems. Its intended use and device description indicate it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description clearly indicates a physical implantable device (Acetabular Cups) with specific dimensions and materials, requiring surgical implantation using instrumentation. This is not a software-only device.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a physical implantable device (an acetabular cup) used in surgical procedures for hip replacement and revision. It is implanted directly into the patient's body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
Therefore, based on the provided information, the Implex A-240 HEP Acetabular Cup System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The use of the Implex A-240 HEP Acetabular Cup System is indicated for:
a) Total Hip Replacement in severely disabled joints as a result of degenerative arthritis or avascular necrosis;
b) Secondary revision of a previously unsuccessful acetabular component;
c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results;
d) Fracture dislocation of the hip, or irreducible fractures in which adequate fixation cannot be obtained;
e) Non-union of femoral neck or head fractures; and
f) Salvage of a failed primary or secondary total or hemi hip.
Product codes
LPH
Device Description
Implex A-240 HEP Acetabular Cups 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 A-240 HEP 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
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 characterize the materials and the Performance Data: performance 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 A-230 Porous Acetabular Cup System, Non-Cemented
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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JUN 19 1997
510(k) SUMMARY - IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
| Submitter Name: | Implex Corp. | ||
|---|---|---|---|
| Submitter Address: | 80 Commerce Drive | ||
| Allendale, New Jersey 07401-1600 | |||
| Contact Person: | Robert Cohen or Robert Poggie | ||
| Phone Number: | (201) 818-1800 | ||
| Fax Number: | (201) 818-0567 | ||
| Date Prepared: | November 8, 1996 | ||
| Device Trade Name: | Implex A-240 HEP Acetabular Cup System | ||
| Device Common Name: | Acetabular Cup | ||
| Classification Name: | Prosthesis, Hip, Acetabular Component, Non-Cemented | ||
| Predicate Device: | Implex A-230 Porous Acetabular Cup System, Non- | ||
| Cemented | |||
| Device Description: | Implex A-240 HEP Acetabular Cups 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 A-240 HEP Acetabular Cups are to be | |||
| implanted using the Implex Acetabular Cup Instrumentation | |||
| System. | |||
| Indications For Use: | The use of the Implex A-240 HEP Acetabular Cup System is | ||
| indicated for: | |||
| a) Total Hip Replacement in severely disabled joints as | |||
| a result of degenerative arthritis or avascular | |||
| necrosis; | |||
| b) Secondary revision of a previously unsuccessful | |||
| acetabular component; | |||
| c) Other hip problems where clinical experience has | |||
| shown that alternative modes of treatment are less | |||
| likely to achieve satisfactory results; | |||
| d) Fracture dislocation of the hip, or irreducible | |||
| fractures in which adequate fixation cannot be | |||
| obtained; | |||
| e) Non-union of femoral neck or head fractures; and | |||
| f) Salvage of a failed primary or secondary total or | |||
| hemi hip. |
1
The surgical instrumentation and design geometry of the Device Technological predicate Implex A-230 Porous Acetabular Cup System, Characteristics and Non-Cemented, and the Implex A-240 HEP Acetabular Cup Comparison to System are equivalent. The primary difference between the Predicate Device: two device systems, is the porous metal of the shell. The Implex A-240 HEP Acetabular Cup shell is comprised of porous tantalum, and the Implex A-230 Porous Acetabular Cup is comprised of porous coated titanium alloy. Testing conducted to characterize the materials and the Performance Data: performance characteristics of the device under defined laboratory conditions was provided to support a finding of substantial equivalence. Conclusion: The Implex A-240 HEP Acetabular Cup System is
substantially equivalent to the predicate device in terms of intended use, safety, and effectiveness.
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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Glenn N. Byrd, MBA Associate Director of Regulatory Affairs Advanced Bioresearch Associates 1700 Rockville Pike, Suite 450 Rockville, Maryland 20852-1631
JUN 19 1997
參
K964509 Re : Trade Name: Implex A-240 HEP Acetabular Cup System Requlatory Class: II Product Code: LPH Dated: March 21, 1997 Received: March 21, 1997
Dear Mr. Byrd:
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, Druq, 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, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic
3
Page 2 - Glenn N. Byrd, MBA
GMP 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.
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,
r Ce lla 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:
专
1:02 FMI ;
Implex A-240 HEP Acetabular Cup System
Indications For Use: ... . . . . . . .
The use of the Implex A-240 HEP Acetabular Cup System is indicated for :
- a) Total Hip Replacement in severely disabled joints as a result of degenerative arthritis or avascular necrosis;
- b) Secondary revision of a previously unsuccessful acetabular component;
- c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results;
- ನು Fracture dislocation of the hip, or irreducible fractures in which adequate fixation cannot be obtained;
- Non-union of femoral neck or head fractures; and e )
- £) Salvage of a failed primary or secondary total or hemi hip.
(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 | K964509 |
| Prescription Use
| (Per 21 CFR 801.109) | OR... | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ------- | ---------------------- |
(Optional Format 1-2-96)