(75 days)
Natural-Hip HA Stem (Sulzer Orthopedics Inc.), APR Universal Hip Stem with Calcitite - Coated CSTi (Sulzer Orthopedics Inc.)
Not Found
No
The document describes a mechanical orthopedic implant (femoral stem) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes.
The device is a femoral stem intended to treat conditions like avascular necrosis, osteoarthritis, and rheumatoid arthritis, which are patient conditions related to disease or injury, thus classifying it as a therapeutic device.
No
This device is a femoral stem, part of a total hip replacement system, used to treat non-inflammatory degenerative joint disease, inflammatory joint disease, or provide revision for failed previous surgeries. It is an implantable medical device, not a diagnostic tool.
No
The device description clearly details a physical implant (femoral stem) made of wrought Ti-6A1-4V with ceramic hydroxylapatite coating, intended for surgical implantation in the femur and hip joint. This 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, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a femoral stem, which is a component of a hip replacement implant. This is a surgically implanted device used to replace a damaged or diseased part of the femur (thigh bone) and hip joint.
- Intended Use: The intended use clearly states it's for treating conditions like osteoarthritis and rheumatoid arthritis, and for revision of failed arthroplasty. These are surgical procedures and conditions treated with implanted devices, not through laboratory testing of samples.
The description focuses on the physical characteristics, materials, and surgical application of the implant, not on any diagnostic testing performed on bodily fluids or tissues.
N/A
Intended Use / Indications for Use
The APR Porous HA Hip Stem is intended to replace the anatomy of the femur in cases of total the xi k rechio replacement. The general indications associated with the use of the APR Porous HA Hip Stem in total hip arthroplasty include:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or 2. dysfunction persists.
- Revision of previously failed hip arthroplasty 3.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient, and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
The APR Porous HA Hip Stem is intended only for use without bone cement in the United States. This device is intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
LPH, MEH
Device Description
The APR Porous HA femoral stem is anatomically designed with right and left components. These stems are available in three proximal body styles to optimize fit of the hip stem in the femoral canal: a standard body, a large body in which the proximal anterior dimension has been widened slightly to maximize filling of the proximal femur, and an oversized for the patient exhibiting the endosteal canal shape (sometimes referred to as Type A) in which the diablysis is disproportionately smaller than the metaphysis. The larger sizes of the stems are stems feature distal hollowing for increased stem flexibility.
The stems are manufactured from wrought Ti-6A1-4V (ASTM F-136). The stems are fabricated with a neck and stem designed to match the natural shape and curve of the femur. Ceramic hydroxylapatite (HA) coated Cancellous-Structured Titanium (CST)) is located on the inferior side of the collar as well as the proximal femoral body. A morse-type taper on the proximal aspect of the stem permits attachment of one of a variety of femoral heads.
This device is intended for use with the following previously cleared devices:
- I IOI metallic femoral bearing heads
- IOI Biolox Bearing Heads
- Zirconia Bearing Heads
- IOI acetabular components
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral canal, proximal femur
Indicated Patient Age Range
younger patients (under certain conditions)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Natural-Hip HA Stem (Sulzer Orthopedics Inc.), APR Universal Hip Stem with Calcitite - Coated CSTi (Sulzer Orthopedics Inc.)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV - 3 1997
5100k) SUMMAR
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a 510(k) Summary for the APR Porous HA Hip Stem.
| Submitter: | Sulzer Orthopedics, Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|---------------------------------------------------------------------------------------------------------|
| Date: | August 19, 1997 |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis, 21 CFR 888.3358. |
| Common/Usual Name: | Biologically fixed total hip prosthesis, semi-constrained |
| Trade/Proprietary Name: | APR Porous HA Hip Stem |
PRODUCT DESCRIPTION
The APR Porous HA femoral stem is anatomically designed with right and left components. These stems are available in three proximal body styles to optimize fit of the hip stem in the femoral canal: a standard body, a large body in which the proximal anterior dimension has been widened slightly to maximize filling of the proximal femur, and an oversized for the patient exhibiting the endosteal canal shape (sometimes referred to as Type A) in which the diablysis is disproportionately smaller than the metaphysis. The larger sizes of the stems are stems feature distal hollowing for increased stem flexibility.
The stems are manufactured from wrought Ti-6A1-4V (ASTM F-136). The stems are fabricated with a neck and stem designed to match the natural shape and curve of the femur. Ceramic hydroxylapatite (HA) coated Cancellous-Structured Titanium (CST)) is located on the inferior side of the collar as well as the proximal femoral body. A morse-type taper on the proximal aspect of the stem permits attachment of one of a variety of femoral heads.
This device is intended for use with the following previously cleared devices:
- I IOI metallic femoral bearing heads
- IOI Biolox Bearing Heads
- Zirconia Bearing Heads
- IOI acetabular components
1
SPECIFIC DIAGNOSTIC INDICATIONS
The APR Porous HA Hip Stem is intended to replace the anatomy of the femur in cases of total the xi k rechio replacement. The general indications associated with the use of the APR Porous HA Hip Stem in total hip arthroplasty include:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or 2. dysfunction persists.
- Revision of previously failed hip arthroplasty 3.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient, and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
The APR Porous HA Hip Stem is intended only for use without bone cement in the United States. This device is intended for single use only.
SUBSTANTIAL EQUIVALENCE
The APR Porous HA Hip Stem is substantially equivalent to the Natural-Hip HA Stem (Sulzer Orthopedics Inc.) and the APR Universal Hip Stem with Calcitite - Coated CSTi (Sulzer Orthopedics Inc.).
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1997
Lori Kleinschrodt Holder, RAC Requlatory Affairs Specialist Sulzer Orthopedics Inc. 9900 Spectrum Drive Austin, Texas 78717
K973124 Re: APR Porous HA Hip Stem Regulatory Class: II Product Codes: LPH and MEH Dated: August 19, 1997 Received: August 20, 1997
Dear Ms. Holder:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:
You may not label or in any way promote these devices for enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation. The data presented support equivalence with no additional claims over a conventional porous-coated uncemented hip prosthesis (i.e., biological fixation, only).
Additional limitations for more specific claims of safety and effectiveness may be forthcominq. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.
The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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Page 2 - Lori Kleinschrodt Holder, RAC
You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.
Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning Please note: this your device in the Federal Register. response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
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Page 3 - Lori Kleinschrodt Holder, RAC
obtained from the Division of Small Manufacturers Assistance obtained from the bivibically (800) 638-2041 or (301) 443-6597 or at at fes corrires address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): __k973124
Device Name: APR Porous HA System
Indications For Use:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction 2. persists.
- Revision of previously failed arthroplasty. 3.
The APR Porous HA System is intended only for use without bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use
(Division Sign-Off)
Division of General Restorative Dev Devices
(Optional Format 1-2-96)
510(k) Number. K973124