(51 days)
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No
The description focuses on the mechanical design and materials of a hip stem, with no mention of AI or ML capabilities.
Yes.
The device is a hip stem used for total hip arthroplasty to treat specific medical conditions, which inherently makes it a therapeutic device aimed at treating or alleviating a medical condition.
No
The device description indicates it is a total hip replacement prosthesis (hip stem), designed for surgical implantation rather than for diagnosing medical conditions.
No
The device description clearly details a physical hip stem made of CoCrMo with a porous coating, indicating it is a hardware medical device, not software.
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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a hip stem) intended to be placed inside the patient's body to replace a damaged hip joint. Its purpose is to restore function and alleviate pain caused by various conditions affecting the hip.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from the patient.
The Encore Fully Coated Hip Stem is a Class III medical device (due to being a permanent implant) used in surgical procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Encore Fully Coated Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural 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.
The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including 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. This stem is to be pressfit.
Product codes
LPH, LZO
Device Description
The Encore Fully Coated Hip Stem is available in a variety of proximal body, head offset and distal stem diameter and length configurations. When viewed in the mediolateral plane the Encore Fully Coated Hip Stem tapers slightly proximal to distal in the body area only. The proximal body is trapezoidal in cross-sectional geometry and tapers lateral to medial. The distal stem portion is cylindrical and the larger sizes have anterior/posterior flutes to decrease the distal stem stiffness.
The Encore Fully Coated Hip Stem is fabricated from cast CoCrMo that conforms to ASTM F75. The outside surface of the stem is porous coated with CoCrMo beads (ASTM F75) to provide a porous surface for enhanced fixation. The stem is intended to be press-fit.
The Encore Fully Coated Hip Stem is collared and has a Morse type taper to receive modular heads. This stem is available with a standard head/stem offset and a enhanced offset version that provides additional lateralization of the patient's femur without increasing leg length. The stem/neck angle is 135°.
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
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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
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Summary of Performance Studies
Laboratory testing and finite element analysis was used to determine the fatigue stem strength and Morse type taper was conducted.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500
Trade Name: Encore Fully Coated Hip Stem
Common Name: Cementless hip stem
Classification Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis
Description: The Encore Fully Coated Hip Stem is available in a variety of proximal body, head offset and distal stem diameter and length configurations. When viewed in the mediolateral plane the Encore Fully Coated Hip Stem tapers slightly proximal to distal in the body area only. The proximal body is trapezoidal in cross-sectional geometry and tapers lateral to medial. The distal stem portion is cylindrical and the larger sizes have anterior/posterior flutes to decrease the distal stem stiffness.
The Encore Fully Coated Hip Stem is fabricated from cast CoCrMo that conforms to ASTM F75. The outside surface of the stem is porous coated with CoCrMo beads (ASTM F75) to provide a porous surface for enhanced fixation. The stem is intended to be press-fit.
The Encore Fully Coated Hip Stem is collared and has a Morse type taper to receive modular heads. This stem is available with a standard head/stem offset and a enhanced offset version that provides additional lateralization of the patient's femur without increasing leg length. The stem/neck angle is 135°.
Intended Use: The Encore Fully Coated Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural 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.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include cast CoCrMo substrate, straight stem, symmetric, collar, basic shape, and modular heads.
Test Results: Laboratory testing and finite element analysis was used to determine the fatigue stem strength and Morse type taper was conducted.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 to the right, arranged in a way that suggests unity and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
Ms. Debbie De Los Santos Regulatory and Clinical Specialist Encore Orthopedics, Incorporated 9800 Metric Boulevard Austin, Texas 78758
Re: K992109
Trade Name: Encore Fully Coated Hip Stem Regulatory Class: II Product Code: LPH and LZO Dated: June 21, 1999 Received: June 22, 1999
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 control provisions of the Act. The general control 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 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 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.
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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.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ___ Encore Fully Coated Hip Stem_
Indications For Use:
Encore Fully Coated Hip Stem Indications For Use
The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including 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. This stem is to be pressfit.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _X (per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)_
Aiolley
(Division Sign-Off) Division of General Restorative De 510(k) Number
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