K Number
K961589
Device Name
APR FULLY TEXTURED HIP STEM
Date Cleared
1996-07-09

(76 days)

Product Code
Regulation Number
888.3353
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
intended for prosthetic replacement of the proximal portion of the femur in a hip replacement.
Device Description
The APR® Fully Textured Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement. This device is a nonporous. anatomic femoral component that comes in a variety of sizes in both left and right configurations. This stem is manufactured from wrought Ti-6A1-4V alloy (ASTM F 136) and features surface texturing along the full length of the stem (with the exception of the neck area) for enhanced fixation in cemented or press-fit applications. In addition, the APR® Fully Textured Hip Stem: - incorporates an anterior anguiation in the proximal body to match the normal anterior angulation of the natural femur; - . features a double wedge shaped proximal body to maximize filling of the proximal femur; - has a 12/14 Morse taper making it compatible with modular femoral heads: - . has a distal stem with a circular cross section allowing for ease in canal preparation and prosthesis insertion; and; - incorporates a cylindrical hole in the distal stem of the larger sizes to increase distal stem flexibility.
More Information

Not Found

No
The device description focuses on the material, shape, and mechanical features of a hip stem, with no mention of software, algorithms, or data processing that would indicate AI/ML.

No
The device is a prosthetic replacement for a bone, which falls under the category of a medical device intended to replace a body part, not to treat or cure a disease or condition.

No

The device is a prosthetic implant (hip stem) for femoral replacement, not a tool used to diagnose medical conditions or diseases.

No

The device description clearly details a physical implant made of Ti-6A1-4V alloy with specific anatomical features and manufacturing processes, indicating it is a hardware device, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Description: The provided description clearly states that this device is a prosthetic replacement for a portion of the femur. It is an implantable device used in surgery.
  • Intended Use: The intended use is for prosthetic replacement in a hip replacement procedure. This is a surgical intervention, not a diagnostic test performed on a sample.

The device is a surgical implant, not a diagnostic tool.

N/A

Intended Use / Indications for Use

The APR® Fully Textured Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement.

Product codes

Not Found

Device Description

The APR® Fully Textured Hip Stem is a nonporous, anatomic femoral component that comes in a variety of sizes in both left and right configurations. This stem is manufactured from wrought Ti-6A1-4V alloy (ASTM F 136) and features surface texturing along the full length of the stem (with the exception of the neck area) for enhanced fixation in cemented or press-fit applications. In addition, the APR® Fully Textured Hip Stem:

  • incorporates an anterior anguiation in the proximal body to match the normal anterior angulation of the natural femur;
  • . features a double wedge shaped proximal body to maximize filling of the proximal femur;
  • has a 12/14 Morse taper making it compatible with modular femoral heads:
  • . has a distal stem with a circular cross section allowing for ease in canal preparation and prosthesis insertion; and;
  • incorporates a cylindrical hole in the distal stem of the larger sizes to increase distal stem flexibility.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

proximal portion of the femur in a hip replacement

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

the Bi-Metric Primary Interlok Hip Stem (Biomet, Inc.), the Alloclassic Zweymüller Cementless Stem (Sulzer Orthopedics, AG)

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

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® Fully Textured Hip Stem.

| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717
(512) 432-9687 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| Date: | April 23, 1996 |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis, 21CFR
888.3353 |
| Common/Usual Name: | Femoral Component |
| Trade/Proprietary: | APR® Fully Textured Hip Stem |

Product Description/Substantial Equivalence:

Jul

9 1996

The APR® Fully Textured Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement. This device is a nonporous. anatomic femoral component that comes in a variety of sizes in both left and right configurations. This stem is manufactured from wrought Ti-6A1-4V alloy (ASTM F 136) and features surface texturing along the full length of the stem (with the exception of the neck area) for enhanced fixation in cemented or press-fit applications. In addition, the APR® Fully Textured Hip Stem:

  • incorporates an anterior anguiation in the proximal body to match the normal anterior angulation of the natural femur;
  • . features a double wedge shaped proximal body to maximize filling of the proximal femur;
  • has a 12/14 Morse taper making it compatible with modular femoral heads:
  • . has a distal stem with a circular cross section allowing for ease in canal preparation and prosthesis insertion; and;
  • incorporates a cylindrical hole in the distal stem of the larger sizes to increase distal stem flexibility.

The APR® Fully Textured Hip Stem is substantially equivalent to the Bi-Metric Primary Interlok Hip Stem (Biomet, Inc.) and the Alloclassic Zweymüller Cementless Stem (Sulzer Orthopedics, AG).