(79 days)
I'm sorry, I cannot identify the Predicate Device(s) K/DEN number from the input "Not Found". The text does not contain any K/DEN numbers.
Not Found
No
The description focuses solely on the materials, sizes, and mechanical features of a total hip replacement system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for the treatment of various arthritic conditions, which implies a therapeutic purpose.
No
The device description indicates it is a prosthetic total hip system, used for treatment, not for diagnosing conditions.
No
The device description clearly details physical components made of materials like cobalt chrome and UHMWPE, indicating it is a hardware medical device (a total hip system).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the treatment of conditions like osteoarthritis and rheumatoid arthritis by replacing the hip joint. This is a therapeutic intervention, not a diagnostic one.
- Device Description: The device is a prosthetic hip system, consisting of physical components (femoral stem, acetabular insert, acetabular shell) designed to be implanted in the body. IVDs are typically reagents, instruments, or systems used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the Horizon Hip System is a medical device, specifically a prosthetic implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
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
510 (k) Summary
OCT -3 1996
Submitted By: Biopro 17 17th Street Port Huron, MI 48060
Cheryl Warsinske Contact: Fax (810) 982-7794 (810) 982-7777
Device Information:
proprietary name: Horizon Hip System common name: prosthetic. Total Hip System classification name: prosthetic, Total Hip System
Femoral component
The Horizon Femoral Stem is manufactured from cobalt chrome and features a collar to distribute stress in a physiological manner. It is available with or without porous coating. The femoral component is available in five sizes: 12mm, 15mm, 16,5mm, and 18mm.
Acetabular Insert
The Horizon Acetabular Insert is manufactured of UHMWPE. It is designed to snap fit into the acetabular shell. The insert will accept 28mm heads. It is offered in sizes ranging from 46mm to 60mm.
Acetabular Shell (cup)
The Horizon Acetabular Shell is manufactured of cobalt chrome. It features three spikes to prevent rotation. It also features a groove on its I.D. to accept the mating acetabular insert. The acetabular shell is porous coated to promote long term fixation. The acetabular shell is available in eight sizes: 46mm, 48mm, 52mm, 52mm, 56mm, 56mm, and 60mm.
Substantial Equivalence:
The Horizon femoral stems are substantially equivalent to the Depuy AML femoral stems. Both styles have geometries which include a circular distal cross-section and an oval proximal cross-section for anti-rotation. Both styles are manufactured from cobalt chrome and are porous coated at least 5/8 of the way down the stem. The Horizon system also includes a non-porous coated stem option. Although both sets of stems have collars, the angle of the collar varies. The Horizon stems have a collar positioned at 20° from the horizontal, while the Depuy stems have a collar positioned at 45° from the horizontal. The collar positioned at 20° resists the joint loads more efficiently and reduces the shear stresses at the bone/implant interface. The mode of extraction for the stems also differs. The extraction instrument for the Horizon stems fits on the collar; whereas, the Depuy stems contain a hole in the proximal region to allow attachment of an extraction instrument Additionally, the tapers present on the two stem styles differ. The Horizon taper is designed to accept a Biopro ceramic or cobalt chrome chrome head while a Depuy stem is designed to accept a Depuy head
1
The Horizon acetabular cup is substantially equivalent to the AML Plus Deput cup. Both designs are porous coated on the entire ().D. of the shell and have three spikes projecting from the O.D. for stabillization and anti-rotation. The Horizon cup is manufactured from cobalt chrome and does not have any screw holes in it This fact makes the joint more resistant to loosening because there is less particulate debris. (In the other hand, the Depuy cup is made of titanium and has screw holes. The locking mechanisms for the two cups differ slightly. The Horizon cup has a locking lip around the I.D. to accommodate the insert. The Depuy cup contains rectangular grooves to accommodate its insert.
The acetabular inserts for both the Horizon hip system and the Depuy AML system are manufactured from UHMWPE. They have grooves for dialability and snap into the acetabular cup via their respective locking mechanisms. The Horizon insert is available with a 28mm I.D. or a 32mm I.D. The AML Depuy insert is available with a 26mm, 28mm, or 32mm I.D.
Although there are minor differences between the Horizon and Depuy components, they are substantially equivalent in form and function. Both systems are indicated for treatment of osteoarthritis, rheumatoid arthritis, avascular necrosis, and traumatic arthritis. Contraindications include: excessive bone loss, septic arthritis, periarticular osteomyelitis, and local or systemic infection.
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