(90 days)
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Not Found
No
The summary describes a mechanical implant (acetabular cup) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is intended to treat conditions like osteoarthritis and arthritis, relieve hip pain, and restore hip motion, which are therapeutic actions.
No
The device is an acetabular cup, which is an implant used in total hip arthroplasty to replace the natural acetabulum. Its purpose is to relieve pain and restore hip motion, not to diagnose medical conditions.
No
The device description clearly states it is a physical implant fabricated from Ti-6Al-4V with a porous coating, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the treatment of patients undergoing total hip arthroplasty. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant (acetabular cup) made of titanium, designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, the Foundation® Porous Coated Flared Rim Acetabular Cup is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Foundation® Porous Coated Flared Rim Acetabular Cup is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necresis or family and fracture, and revision arthromasty where hone loss is minimal. This system includes a metal-backed sineli and modular polyethylene liner and is to be used press-fit. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Product codes
LPH
Device Description
The Foundation® Porqus Coated Flared Rim Acetabular Cup is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136. The outside surfaces are coated with commercially pure titanium beads (ASTM F67) for the purpose of providing a porous surface for enhanced press-fit fixation.
The flared shells are available with and without screw holes. It is hemispherical in shape and is available in sizes 44mm - 70mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip joint / femoral head and neck / acetabulum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Testing on this device included attachment strength of liners to shell. All results are sufficient for in-vivo loading.
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. 9800 Metric Blvd. Austin, TX 7875 512-832-9500
: 14:4
Trade Name: Foundation® Porous Coated Flared Rim Acetabular Cup
Common Name: Metal backed acetabular component
Classification Name: Hip joint metal/polymer semi-constrained uncemented prosthesis per 21 CFR 888.3358
Description: The Foundation® Porqus Coated Flared Rim Acetabular Cup is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136. The outside surfaces are coated with commercially pure titanium beads (ASTM F67) for the purpose of providing a porous surface for enhanced press-fit fixation.
The flared shells are available with and without screw holes. It is hemispherical in shape and is available in sizes 44mm - 70mm.
Intended Use: The Foundation® Porous Coated Flared Rim Acetabular Cup is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. The intended use is press-fit.
Comparable Features to Predicate Device(s): The spherical shape, titanium substrate, and the indexability of liners in shell and bone screw holes are features that are comparable to other devices in commercial distribution. The outside surface of the shell is porous coated to provide a porous surface for enhanced fixation.
Test Results: Testing on this device included attachment strength of liners to shell. All results are sufficient for in-vivo loading.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IAN 2 8 1998
Ms. Debbie De Los Santos ·Requlatory Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758
K974093, K974095, and K973119 Re: Trade Name: Foundation® Porous Coated Spiked Acetabular Cup Foundation® Porous Coated Hemispherical Acetabular Cup Foundation® Porous Coated Flared Rim Acetabular Cup Regulatory Class: II Product Code: LPH Dated: October 28 and November 19, 1997 October 30 and November 21, 1997 Received:
Dear Ms. De Los Santos:
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 enclosures) 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), jt 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 Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 requlations.
2
Page 2 - Ms. Debbie De Los Santos
This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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,
elia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
3
| 510(k) Number (if known): | K974095 |
|---|---|
| Device Name: | FOUNDATION POROUS COATED FZARED Rim ACETABULAR CUP |
| Indications For Use: |
Foundation® Porous Coated Flared Rim Acetabular Cup Indications For Use
The Foundation® Porous Coated Flared Rim Acetabular Cup is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necresis or family and fracture, and revision arthromasty where hone loss is minimal. This system includes a metal-backed sineli and modular polyethylene liner and is to be used press-fit. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alan Webb
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974098
Prescription Use (per 21 CFR 801.109)
という
OR
Over-The-Counter Use
(Optional Format 1-2-96)