(86 days)
The Foundation® Unipolar femoral head is intended for treatment of patients who are candidates for hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis of femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the srugeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with any stem that has the appropriate size head. This submission includes the unipolar femoral head with a modular neck length sleeve.
The Foundation® Unipolar headis fabricated from cast CoCrMo that conforms to ASTM F795. The modular neck length sleeve is fabricated from Ti-6A1-4V that conforms to ASTM F136.
This device is assembled by the surgeon at the time of implantation. The sleeve is placed on the taper of the femoral component and impacted into place. Next the unipolar head is placed on the taper and using the impactor is locked into place.
The unipolar head may be used with any stem that has the appropriate Morse Taper.
The provided text is a 510(k) summary for a medical device called the Foundation® Unipolar Femoral Head with Modular Neck Length Sleeve. It describes the device, its intended use, and states that testing was performed. However, it does not contain acceptance criteria for the device's performance, nor does it detail a study that proves the device meets specific acceptance criteria.
The document states: "Testing on this device included fatigue testing on the unipolar head and the modular neck length sleeve. As well as, axial pull off and torque strength of the modular neck length sleeves." This confirms that some testing was done, but no results or performance metrics are provided.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, ground truth establishment, or human-in-the-loop performance, as this information is not present in the provided text.
The closest information available is related to comparable features to predicate devices, which notes: "The Foundation® Unipolar head has the same geomety, is manufactured from the same material, and has the same indications as the predicate devices." This implies that the acceptance for the device heavily relies on its substantial equivalence to existing, legally marketed devices.
If this were a typical AI/ML device submission, the provided information would be insufficient to describe the acceptance criteria and the study proving it. For hardware like this, the "acceptance criteria" are usually linked to industry standards for mechanical performance and bio-compatibility, and the "study" would be a series of engineering tests. The text only vaguely mentions the types of tests performed, not the results or the thresholds for acceptance.
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K973614
Summary of Safety and Effectiveness
18 1997
Encore Orthopedics, Inc. 9800 Metric Blvd. Austin, TX 78758 (512) 834-6237
Foundation® Unipolar Femoral Head with Modular neck length sleeve Trade Name:
Unipolar head Common Name:
Classification Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis per 21 CFR 888.3360.
The Foundation® Unipolar headis fabricated from cast CoCrMo that conforms to Description: ASTM F795. The modular neck length sleeve is fabricated from Ti-6A1-4V that conforms to ASTM F136.
This device is assembled by the surgeon at the time of implantation. The sleeve is placed on the taper of the femoral component and impacted into place. Next the unipolar head is placed on the taper and using the impactor is locked into place.
The unipolar head may be used with any stem that has the appropriate Morse Taper.
Intended Use: The Foundation® Unipolar femoral head is intended for treatment of patients who are candidates for hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis of femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the srugeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with any stem that has the appropriate size head. This submission includes the unipolar femoral head with a modular neck length sleeve.
Comparable Features to Predicate Device(s): The Foundation® Unipolar head 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 unipolar head and the modular neck length sleeve. As well as, axial pull off and torque strength of the modular neck length sleeves.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human face in profile, composed of three overlapping silhouettes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debbie De Los Santos Requlatory/Clinical Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758
DEC 1 8 1997
K973614 Re : Foundation® Unipolar Femoral Head with Modular Neck Length Sleeves Regulatory Class: II Product Code: KWL Dated: September 19, 1997 September 23, 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 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 Requlations, Title 21, Parts 800 to 895. ਮੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlation may result in requlatory 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.
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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.qov/cdrh/dsmamain.html".
Sincerely yours,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Encore Orthopedics, Inc. 510(k) Submission Foundation® Unipolar Hip Page 4
510(k) Number (if known): 1973614
Device Name:
Indications For Use:
Foundation® Unipolar Femoral Head and Modular Neck Length Sleeve Indications For Use
The Foundation® Unipolar femoral head is intended for treatment of patients who are candidates for hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, theumatoid arthritis, avascular necrosis of femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the srugeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with any stem that has the appropriate size head. This submission includes the unipolar femoral head with a modular neck length sleeve.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF HEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE)
coeefo
510(k) Num
Prescription Use X (per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.