(211 days)
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No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for rehabilitating hips damaged by various joint diseases and traumatic injuries, which is a therapeutic purpose.
No
The device description indicates it is a total hip system, which is an implant used for hip replacement surgery due to joint disease or injury. Its purpose is to rehabilitate damaged hips, not to diagnose conditions.
No
The device description clearly outlines physical components (femoral stems, femoral heads, acetabular shells, acetabular inserts) made of materials like Cobalt Chrome and UHMWPe, and describes physical testing (fatigue analysis, push-out testing, etc.). This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a hip system consisting of implants (femoral stems, heads, acetabular shells, and inserts) designed to be surgically implanted into the body to replace damaged hip joints.
- Intended Use: The intended use is for surgical implantation in skeletally mature individuals to rehabilitate damaged hips. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
Therefore, the APR Hip System with Calcitite-Coated CST is a medical device, specifically a prosthetic implant, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The APR Hip System with Calcitite-Coated CST is indicated for noncemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of Inflammatory Joint Disease (e.g., theumatoid arthritis) or Noninflammatory Degenerative Joint Disease (e.g., osteoarthritis, avascular necrosis, traumatic arthritis, fracture dislocation of the hip and femoral neck fracture).
Product codes
LPH
Device Description
The APR Total Hip System consists of four basic components: anatomically shaped APR II and APR II-T femoral stems. Cobalt Chrome (CoCr) and ceramic femoral heads. APR acctabular metal shells, and Ultra-High Molecular Weight Polyethyiene (UHMWPe) acetabular inserts. The porous surfaces of the femoral and acetabular components are coated with Calcitite® coating.
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
Hip
Indicated Patient Age Range
skeletally mature individuals
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
Fatigue analysis and stem strain gauge analysis indicated that both the APR II-T femoral stems should survive physiologic loading. Axial push-out, and lever-out testing performed on the APR acetabular insert and shell indicated that the device should perform favorably in-vivo.
Fatigue, tensile and shear test of the bond between the Calcitite-porous surface coating and the substrate indicate that the costing bond strength should be adequate for the intended use of the device. Additionally, in vivo studies showed that the interface between the bone and porqus coating exhibited strength over time.
A clinical study conducted under an approved IDE showed that good to excellent clinical results can be expected in noncemented use of this prosthesis provided that stable initial fixstion can be achieved.
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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§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
954800
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a Summary of Safety and Effectiveness for the APR® Hip System with Calcitite®-Costed Cancellous-Structured Titanium (CSTi ).
| Submitter: | Intermedics Orthopedics", Inc.
9900 Spectrum Drive
Austin, Texas 78752
(512) 432-9900 |
|----------------------|------------------------------------------------------------------------------------------------------|
| Date: | February 5, 1996 |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Hip Joint Metal/Polymer/Metal Semi-Constrained Porous
Coated Uncemented Prosthesis (CFR 888.3358) |
| Common/Usual Name: | Biologically fixed total hip prosthesis, semi-constrained |
| Trade/Proprietary: | APR® Hip System with Calcitite®-Coated Cancellous-
Structured Titanium (CSTI) |
PRODUCT DESCRIPTION/SUBSTANTIAL EQUIVALENCE:
The APR Total Hip System consists of four basic components: anatomically shaped APR II and APR II-T femoral stems. Cobalt Chrome (CoCr) and ceramic femoral heads. APR acctabular metal shells, and Ultra-High Molecular Weight Polyethyiene (UHMWPe) acetabular inserts. The porous surfaces of the femoral and acetabular components are coated with Calcitite® coating.
Femoral Components
The APR II and APR II-T femoral components are anstomically designed with right and left components available in six regular sizes and six large sizes. The components are manufactured from wrought Ti-6AI-4V (ASTM F136). The APR II and APR II-T anstomic femoral prostheses are fabricated with a neck and stem designed to mach the natural shape and curve of the femur. Calcitite® coating has been applied to the Cancellous Structured Titanium (CST) ) located on the inferior side of the collar as well as the anterior, posserior and medial surfaces of the proximal femoral body. Additionally, the costing is also applied to the CSTI found on the lateral surface of the APR II-T stem. A morse-type taper on the proximal aspect of the stem permits attachment of one of a variety of femoral heads.
Femoral Head Components
The CoCr mesallic and Zirconia and Alumina ceramic modular femoral heads attach to the APR II and APR II-T femoral components via a Morse-type tager. The CoCr femoral heads are manufactured from wrought CoCr conforming to ASTM F799. The ceramic heads are manufactured from either zirconium oxide (zirconia) or aluminum oxide (alumina). The CoCr femoral heads are available with the HOI taper (26mm, 28mm diameters) or 12/14 taper (22mm, 26mm, 28mm and 32mm diameters); the ceramic heads are available in 28mm and 32mm
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1
diameters and fit on the 12/14 taper. A variety of neck lengths are offered for each head type.
Acetabular Component
The APR acetabular shell is a hemischerical modular component manufactured from wrought Ti-6Al-4V (ASTM F136) conforming to ASTM F136. The shell is fixed into place using bone screws. Calcitite-coated CSTI has been applied to the outer spherical surface of the component. with the exception of the dome and resion adiaces to the screw holes. The modular desire of the acetabular shell permits use of a variety of acetabular inserts. The shell is available in 16 sizes.
Acetabular Inserts
The APR acetabular inserts are manufactured from UHMWPe (ASTM F648) and are available in three types: standard, hooded and hooded protrusio. They are available in various sizes and diameters to articulate with the femoral heads. The plastic inserts are snapped into the metal shell at the time of surgery and can be fixed at one of 12 positions. Antirotation is achieved with a pin on the plastic insert that fits into a slot on the acetabular shell.
The APR Hip System with Calcitite-Coated CST is indicated for noncemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of Inflammatory Joint Disease (e.g., theumatoid arthritis) or Noninflammatory Degenerative Joint Disease (e.g., osteoarthritis, avascular necrosis, traumatic arthritis, fracture dislocation of the hip and femoral neck fracture).
Fatigue analysis and stem strain gauge analysis indicated that both the APR II-T femoral stems should survive physiologic loading. Axial push-out, and lever-out testing performed on the APR acetabular insert and shell indicated that the device should perform favorably in-vivo.
Fatigue, tensile and shear test of the bond between the Calcitite-porous surface coating and the substrate indicate that the costing bond strength should be adequate for the intended use of the device. Additionally, in vivo studies showed that the interface between the bone and porqus coating exhibited strength over time.
A clinical study conducted under an approved IDE showed that good to excellent clinical results can be expected in noncemented use of this prosthesis provided that stable initial fixstion can be achieved.
The APR® Hip System with Calcitite®-Costed Cancellous-Structured Thanium (CST) ) is similar to the Intermedics Orthopedics APR II and APR II-T with CST, the Intermedics Orthopedics APR and APR II with Calcitite Coating, the Howmedica Precision Osteolock, and the Osteonics Omnifit with HA.
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