(161 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is described as a "total hip replacement prosthesis" intended for "relieving the patient of hip pain and restoring hip motion" due to various debilitating conditions of the hip joint, which are therapeutic goals.
No
This device is an implantable medical device (acetabular system for total hip arthroplasty) used to treat conditions like osteoarthritis and hip fractures. It is designed to relieve pain and restore motion, not to diagnose a condition.
No
The device description clearly states it is fabricated from physical materials (Ti-6AI-4V, titanium beads, polyethylene) and is a physical implant (acetabular cup and liners) for total hip arthroplasty.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical treatment of hip joint conditions through total hip arthroplasty and revision arthroplasty. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a physical implant (acetabular cup and liner) designed to replace a damaged hip joint. It does not involve reagents, instruments for analyzing biological samples, or any other components typically associated with IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant used in surgery.
N/A
Intended Use / Indications for Use
The Foundation® Porous Acetabular System 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.
The indications for use of the total hip replacement prosthesis include: The increations 101 degenerative joint disease including osteoarthritis and nonimianmatory - organisatoid arthritis; correction of functional deformity; avasodial nocroors, where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the treatinent of their with head involvement, which is unmanageable using other techniques.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The Foundation® Porous Acetabular System Cups are fabricated from wrought/forged or cast Ti-6AI-4V that conforms to ASTM F136 or F1108, respectively. 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 hemispherical and flared shells are available with and without screw holes. The geometry of the screw holes is such that a 12° angulation of the screws is possible.
The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral, 10°, and 20° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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 on this device included attachment strength of liners to shell. All results are sufficient for in-vivo loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Summary of Safety and Effectiveness
x973119
Encore Orthopedics®, Inc. 9800 Metric Blvd. Austin, TX 7875 512-832-9500
Trade Name: Foundation® Porous Acetabular System
Common Name: Metal backed acetabular component
Classification Name: Hip joint metal/polymer semi-constrained uncemented prosthesis per 21 CFR 888.3358
Description: The Foundation® Porous Acetabular System Cups are fabricated from wrought/forged or cast Ti-6AI-4V that conforms to ASTM F136 or F1108, respectively. 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 hemispherical and flared shells are available with and without screw holes. The geometry of the screw holes is such that a 12° angulation of the screws is possible.
The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral, 10°, and 20° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
Intended Use: The Foundation® Porous Acetabular System 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 hemispherical and flared shell shape, titanium substrate, 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 roughened 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 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 an abstract symbol resembling a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IAN 288 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 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. Please note: concerning your device in the Federal Register. 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 - Ms. Debbie De Los Santos
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,
Ph.D., M.D. elia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
3
| 510(k) Number (if known): | K973119 |
|---|---|
| Device Name: | FOUNDATION POROUS COATED |
| SPIKED ACETABULAR CUP | |
| Indications For Use: |
Foundation® Porous Acetabular Cup System Indications For Use
The indications for use of the total hip replacement prosthesis include: The increations 101 degenerative joint disease including osteoarthritis and nonimianmatory - organisatoid arthritis; correction of functional deformity; avasodial nocroors, where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the treatinent of their with head involvement, which is unmanageable using other techniques.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ala wbb
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
OR
Prescription Use
(per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)_