(80 days)
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Not Found
No
The summary describes a mechanical implant (hip stem) and its design features, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a hip stem for prosthetic replacement, which is a restorative or replacement device, not a therapeutic device meant to treat a disease or condition.
No
The device is a prosthetic hip stem for replacement of the proximal femur, not a diagnostic tool. Its "diagnostic indications for use" refer to conditions it can be used to treat, not that the device itself performs diagnosis.
No
The device description clearly states it is a physical implant manufactured from wrought Ti-6A1-4V alloy, intended for prosthetic replacement of the femur. This is a hardware device, not software.
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 APR Oversized Hip Stem is a physical implantable device intended for surgical replacement of a portion of the femur. It is a prosthetic component, not a test or assay performed on a biological sample.
- Intended Use: The intended use describes the conditions for which the device is used in a surgical procedure, not for diagnosing those conditions through laboratory testing.
Therefore, the APR Oversized Hip Stem falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The APR Oversized Hip Stem is an anatomic femoral component that is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement. Specific diagnostic indications for use of the APR Oversized Hip Stem include: patient conditions of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis secondary to a variety of diseases and anomalies; avascular necrosis of the femoral head and/or non-union of femoral neck fractures; femoral fractures; and fracture dislocation of the hip.
Product codes
888.3358, 888.3353
Device Description
The APR Oversized Hip Stem is an anatomic femoral component that is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement. This device is manufactured from wrought Ti-6A1-4V alloy (ASTM F 136) and is available in both porous and nonporous versions for use in cemented or press-fit applications. The APR Oversized Hip Stem will be offered with the intent of augmenting IOI's anatomic product line by addressing the metaphyseal mismatch found in a significant portion of the patient population. While the currently marketed APR Hip Stem is a proportional design, the APR Oversized Hip Stem is designed for the Type A endosteal canal in which the diaphysis is disproportionately smaller than the metaphysis. By adding this "proximally upsized," or "oversized," version to the currently marketed product line, the surgeon can obtain good fit and fill of the medullary canal without sacrificing distal cortical bone in those patients which exhibit proximal/distal mismatch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal portion of the femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The strength of the APR Oversized Hip Stem was analyzed using theoretical calculations and fatigue loading conditions and shown to be comparable to other legally marketed devices.
Key Metrics
Not Found
Predicate Device(s)
OMNIFIT® Specialty™ Femoral Stem (Osteonics Corp.), PFCTM Total Hip System (Johnson & Johnson, Inc.), Ranawat/Burstein Total Hip System (Biomet, Inc.), Stability™ Total Hip System (DePuy, Inc.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) SUMMARY
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Intermedics Orthopedics, Inc. APR® Oversized Hip Stem.
| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717
(512) 432-9687 | K96192 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date: | May 15, 1996 | AUG - 5 1996 |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs | |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-
coated uncemented prosthesis, 21 CFR 888.3358
Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis, 21 CFR
888.3353 | |
| Common/Usual Name: | Femoral Component | |
| Trade/Proprietary: | APR® Oversized Hip Stem | |
Product Description/Substantial Equivalence:
The APR Oversized Hip Stem is an anatomic femoral component that is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement. This device is manufactured from wrought Ti-6A1-4V alloy (ASTM F 136) and is available in both porous and nonporous versions for use in cemented or press-fit applications. The APR Oversized Hip Stem will be offered with the intent of augmenting IOI's anatomic product line by addressing the metaphyseal mismatch found in a significant portion of the patient population. While the currently marketed APR Hip Stem is a proportional design, the APR Oversized Hip Stem is designed for the Type A endosteal canal in which the diaphysis is disproportionately smaller than the metaphysis. By adding this "proximally upsized," or "oversized," version to the currently marketed product line, the surgeon can obtain good fit and fill of the medullary canal without sacrificing distal cortical bone in those patients which exhibit proximal/distal mismatch. Specific diagnostic indications for use of the APR Oversized Hip Stem include:
- patient conditions of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, 트 and arthritis secondary to a variety of diseases and anomalies;
- avascular necrosis of the femoral head and/or non-union of femoral neck fractures; 트
- 해 femoral fractures; and
- 트 fracture dislocation of the hip.
1
510(k) Summary APR Oversized Hip Stem Page 2
The strength of the APR Oversized Hip Stem was analyzed using theoretical calculations and fatigue loading conditions and shown to be comparable to other legally marketed devices.
The APR Oversized Hip Stem is substantially equivalent to the OMNIFIT® Specialty™ Femoral Stem (Osteonics Corp.), the PFCTM Total Hip System (Johnson & Johnson, Inc.), the Ranawat/Burstein Total Hip System (Biomet, Inc.), and the Stability™ Total Hip System (DePuy, Inc.).