(30 days)
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No
The description focuses on the mechanical design and materials of a hip stem, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is a total hip replacement prosthesis intended for the treatment of various medical conditions, indicating its therapeutic purpose.
No
The device is a femoral stem intended for use in total or hemi-hip arthroplasty, which is a surgical treatment, not a diagnostic procedure.
No
The device description clearly details a physical, forged CoCrMo alloy femoral stem with specific geometric features, centralizers, and a calcar collar, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip replacement, addressing structural and functional issues within the body. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health.
- Device Description: The description details a physical implant made of metal and PMMA, designed to be surgically inserted into the femur. This is consistent with a medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process related to in vitro testing.
This device is a medical device, specifically a surgical implant.
N/A
Intended Use / Indications for Use
The Foundation 9 mm Forged Cemented Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty. 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 where 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. It is intended to be used with cement with acetabular components or with unipolar heads.
Product codes
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Device Description
The proximal body of the Foundation™ Non-Porous Stem is trapezoidal in cross-sectional geometry and tapers proximal to distal and lateral to medial. The proximal body has two ribs on the anterior and posterior surfaces that run the length of the proximal body. Polymethylmethacrylate "buttons" are placed on the anterior, posterior, lateral and medial surfaces of the proximal body to assure that the implant is centered in the metaphseal region of the femur with a 1.5 mm cement mantle. The proximal body of the femoral stem is grit blasted to a surface of 4-6 u. This device is fabricated from forged CoCrMo alloy.
The distal portion of the stem is conical in shape. It necks down at the distal end to receive a flanged PMMA canal centralizer . This centralizer assures that the distal stem is centered in the femoral canal and helps to maintain a even cement mantle around the distal stem. The Foundation 9 mm Forged Cemented Stem has a calcar collar and has a Morse type taper to receive modular heads. The neck/stem angle is 132°.
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
This stem survived a fatigue load of 3300 N.
Laboratory testing of the Morse type taper was conducted.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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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.
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Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. 8920 Business Park Drive Suite 380 Austin, TX 78759 512-795-8696 J.D. Webb
Trade Name: Foundation™ Non-Porous Stem
Common Name: Cemented total hip
Classification Name: Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350
Description: The proximal body of the Foundation™ Non-Porous Stem is trapezoidal in cross-sectional geometry and tapers proximal to distal and lateral to medial. The proximal body has two ribs on the anterior and posterior surfaces that run the length of the proximal body. Polymethylmethacrylate "buttons" are placed on the anterior, posterior, lateral and medial surfaces of the proximal body to assure that the implant is centered in the metaphseal region of the femur with a 1.5 mm cement mantle. The proximal body of the femoral stem is grit blasted to a surface of 4-6 u. This device is fabricated from forged CoCrMo alloy.
The distal portion of the stem is conical in shape. It necks down at the distal end to receive a flanged PMMA canal centralizer . This centralizer assures that the distal stem is centered in the femoral canal and helps to maintain a even cement mantle around the distal stem. The Foundation 9 mm Forged Cemented Stem has a calcar collar and has a Morse type taper to receive modular heads. The neck/stem angle is 132°.
Intended Use: The Foundation 9 mm Forged Cemented Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty. 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 where 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. It is intended to be used with cement with acetabular components or with unipolar heads.
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Page 2 Encore Orthopedics, Inc. 510(k) Submission Foundation™ 9mm Forged Cemented Stem
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the Foundation® Forged Cemented Stems approved for commercial distribution in K952191, CoCrMo substrate, distal femoral canal centralizer, proximal cement spacers, calcar collar, proximal ribs on body, roughened proximal body, modular heads and unipolar heads.
Test Results: This stem survived a fatigue load of 3300 N.
Laboratory testing of the Morse type taper was conducted.