(88 days)
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Not Found
No
The summary describes a mechanical implant (femoral stem) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is clearly indicated for the treatment of various medical conditions affecting the hip, such as osteoarthritis, fractures, and avascular necrosis, with the purpose of relieving pain and restoring motion. These are therapeutic objectives.
No
The device, a femoral stem for hip arthroplasty, is intended for treatment and restoration of hip motion, not for diagnosing medical conditions.
No
The device description clearly states it is a "femoral stem" fabricated from "wrought/forged Ti-6A1-4V," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant (a femoral stem) used in hip replacement surgery. It is a physical device implanted into the patient's body.
- Intended Use: The intended use clearly states it's for the treatment of patients undergoing total or hemi-hip arthroplasty due to various conditions affecting the femoral head and neck. This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided describes a medical device used for treatment, not for diagnosing a condition using a sample from the body.
N/A
Intended Use / Indications for Use
The Foundation® Fracture Stem 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 and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
The Foundation® Fracture Stem is intended for treatment of patients who are candidates for total or hemi-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 and are intended to be used in a press fit mode.
Product codes
JDI
Device Description
The femoral stem is straight. The proximal body is trapezoidal in cross-sectional geomety. A Morse type taper is used to receive modular heads. The neck/stem angle is 132. The Foundation® Fracture Stem is fabricated from wrought/forged Ti-6A1-4V. The entire stem is grit blasted. The stem is available in six sizes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Femoral head and neck, proximal femur
Indicated Patient Age Range
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Intended User / Care Setting
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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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing on this device included fatigue testing on the Morse type taper.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K973809
Summary of Safety and Effectiveness
Encore Orthopedics, Inc. 9800 Metric Blvd. Austin, TX 78758 (512) 834-6237
Foundation® Fracture Stem Trade Name:
Common Name: Press-fit hip stem
Classification Name: Hip joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3350 and Hip joint Femoral (hemi-hip) metallic uncemented prosthesis per 21 CFR 888.3360
The femoral stem is straight. The proximal body is trapezoidal in cross-sectional Description: geomety. A Morse type taper is used to receive modular heads. The neck/stem angle is 132.
The Foundation® Fracture Stem is fabricated from wrought/forged Ti-6A1-4V. The entire stem is grit blasted. The stem is available in six sizes.
Intended Use: The Foundation® Fracture Stem 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 and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
Comparable Features to Predicate Device(s): The Foundation® Fracture Stem has the same geomety, is manufactured from the same material, and has the same indications as the predicate devices.
Test Results: Testing on this device included fatigue testing on the Morse type taper.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a white space in the shape of a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 2 1998
Ms. Debbie De Los Santos · Regulatory/Clinical Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758
Re : K973809 Trade Name: Foundation Fracture Stem Requlatory Class: II Product Code: JDI Dated: October 2, 1997 Received: October 6, 1997
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 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 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 requirements, 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
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Page 2 - Ms. Debbie De Los Santos
Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asbeing 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,
lely witt
Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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| 510(k) Number (if known): | K97-3809 |
|---|---|
| --------------------------- | ---------- |
Device Name:
Indications For Use:
Foundation® Fracture Stem Indications For Use
The Foundation® Fracture Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, theumatoid 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 and are intended to be used in a press fit mode.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (per 21 CFR 801.109)
: : :
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Clon 4/18
(Division Sign-Off
Division of General Restorative Devices
510(k) Number R97 3809