(247 days)
No
The summary describes a hip implant system and does not mention any AI or ML components or functionalities.
Yes
The device is a ceramic head used in total hip arthroplasty, which is a surgical procedure to treat various conditions affecting the hip joint, thereby providing a therapeutic benefit to the patient.
No
This device is a ceramic head used in total hip arthroplasty, which is a treatment, not a diagnostic procedure.
No
The device description clearly states it is a ceramic head and forged, textured, and porous stems, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating hip joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details ceramic heads and stems for hip arthroplasty, which are physical components implanted in the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions in vitro, or providing information for diagnosis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a medical implant used for surgical treatment.
N/A
Intended Use / Indications for Use
Biolox ceramic heads and Foundation™ Forged, Textured and Porous Stems are 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.
Product codes
Not Found
Device Description
Biolox ceramic heads for use with Foundation™ Forged, Textured and Porous Stems that were cleared for commercial distribution in K952191, K935263 and K952297, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K9SSS63
Encore Orthopedics™, Inc. 8900 Shoal Creek Bldg. 300 Austin, TX 78757 512-795-8696 Ashley M. Bock
AUG - 9 1996
Trade Name: Biolox ceramic heads for use with Foundation™ Forged, Textured and Porous Stems
Common Name: Ceramic femoral head
Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented . prosthesis per 21 CFR 888.3353
Description: Biolox ceramic heads for use with Foundation™ Forged, Textured and Porous Stems that were cleared for commercial distribution in K952191, K935263 and K952297, respectively.
Intended Use: Biolox ceramic heads and Foundation™ Forged, Textured and Porous Stems are 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.
Comparable Features to Predicate Device(s):Features comparable to predicate devices include the Biolox heads used with SL-PLUS and SLR-PLUS Stems cleared for commercial distribution in K930963.