(156 days)
Not Found
Not Found
No
The device description focuses solely on the materials, design features, and mechanical properties of a hip implant. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a hip implant intended for patients with degenerative and inflammatory joint diseases, and for revision of failed previous surgeries, which clearly indicates a therapeutic purpose to alleviate pain, deformity, or dysfunction.
No
Explanation: The device described, the Precedent Revision Hip System, is a hip implant designed for surgical replacement. Its purpose is to treat patient conditions like degenerative joint disease or failed previous surgeries by providing structural support and restoring function, not by diagnosing conditions.
No
The device description clearly details a physical implant made of titanium alloy with specific features like a neck trunnion, grit blasting, hydroxylapatite coating, flutes, and a coronal slot. This is a hardware medical 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 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 description clearly states that this is a "Precedent Revision Hip System," which is a physical implant designed to replace a damaged hip joint. It is made of titanium alloy and is surgically implanted into the femoral canal.
- Intended Use: The intended use describes the patient conditions for which the hip replacement is indicated (degenerative and inflammatory joint diseases, failed previous surgery, revision of failed arthroplasty). This is a description of the clinical conditions the device is intended to treat, not a description of a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information.
Therefore, the Precedent Revision Hip System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Precedent Revision Hip System is primarily intended to address femoral bone deficiencies associated with failure of primary total or hemi-hip arthroplasties. In addition, the Precedent Revision Hip System, like the predicate competitive hip stems, is intended for cementless application.
The general indications associated with the use of the Precedent Revision Hip System 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 dysfunction 2. 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 Precedent Revision Hip System 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)
MEH
Device Description
The Precedent Revision Hip System is manufactured from either wrought or forged titanium The Precedent Revision Hip System features a threaded Sulzer 12/14 configured neck allov. trunnion for attachment to Sulzer Orthopedics' currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore. Precedent Revision Hip System is available in both a collared and collarless design to address surgeon preference. The entire length of the Precedent Revision Hip System, except the neck region and the distal tip, is roughened via the process of grit blasting. The grit blasted proximal surface of the stem is coated with hydroxylapatite (HA). The distal portion of the Precedent Revision Hip System employs flutes which cut into the distal cortices of the prepared femoral canal, thereby providing rotational stability to the hip stem. In addition, the Precedent Revision Hip System employs a coronal slot which potentially reduces bending stiffness of the distal stem and thigh The distal tip of the Precedent Revision Hip System is polished to a machined finish to pain. provide ease of insertion during surgery.
This device is intended for use with the following previously cleared devices:
- Sulzer Orthopedics metallic femoral bearing heads
- Sulzer Orthopedics Biolox Bearing Heads
- Sulzer Orthopedics Zirconia Bearing Heads
- Sulzer Orthopedics bipolar components
- Sulzer Orthopedics unipolar components
- Sulzer Orthopedics acetabular components
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.
Not Found
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
§ 888.3353 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
OCT - 1 1997
K971523 1 of 2
510(k) SUMMARY
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 Summary of Safety and Effectiveness for the Precedent Revision Hip System.
| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Date: | July 17, 1997 |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Hip Joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis - 21CFR 888.3353 (87LZO). |
| Common/Usual Name: | Femoral hip prosthesis |
| Trade/Proprietary Name: | Precedent Revision Hip System |
PRODUCT DESCRIPTION
The Precedent Revision Hip System is manufactured from either wrought or forged titanium The Precedent Revision Hip System features a threaded Sulzer 12/14 configured neck allov. trunnion for attachment to Sulzer Orthopedics' currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore. Precedent Revision Hip System is available in both a collared and collarless design to address surgeon preference. The entire length of the Precedent Revision Hip System, except the neck region and the distal tip, is roughened via the process of grit blasting. The grit blasted proximal surface of the stem is coated with hydroxylapatite (HA). The distal portion of the Precedent Revision Hip System employs flutes which cut into the distal cortices of the prepared femoral canal, thereby providing rotational stability to the hip stem. In addition, the Precedent Revision Hip System employs a coronal slot which potentially reduces bending stiffness of the distal stem and thigh The distal tip of the Precedent Revision Hip System is polished to a machined finish to pain. provide ease of insertion during surgery.
This device is intended for use with the following previously cleared devices:
- Sulzer Orthopedics metallic femoral bearing heads 일
- Sulzer Orthopedics Biolox Bearing Heads 제
- 그 Sulzer Orthopedics Zirconia Bearing Heads
- 발 Sulzer Orthopedics bipolar components
- Sulzer Orthopedics unipolar components 발
- Sulzer Orthopedics acetabular components
SPECIFIC DIAGNOSTIC INDICATIONS
The Precedent Revision Hip System is primarily intended to address femoral bone deficiencies associated with failure of primary total or hemi-hip arthroplasties. In addition, the Precedent Revision Hip System, like the predicate competitive hip stems, is intended for cementless application.
1
The general indications associated with the use of the Precedent Revision Hip System 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 dysfunction 2. 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 Precedent Revision Hip System is intended only for use without bone cement in the United States. This device is intended for single use only.
SUBSTANTIAL EQUIVALENCE
The Precedent Revision Hip System is substantially equivalent to the following legally marketed predicate competitive devices:
- Restoration HA Hip Stem: Osteonics Corporation. 1
- 비 Sentry Femoral Component: Howmedica Inc.
- 프 S-ROM® Femoral Prosthesis: Joint Medical Product Corporation.
- 월 Stability Hip Stem: DePuy Inc.
- 189 Wagner Revision Stem: Protek Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lori K. Holder, RAC ·Regulatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
OCT - I
Re : K971523 Precedent Revision Hip System Requlatory Class: II Product Code: MEH Dated: July 25, 1997 Received: July 28, 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 "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, 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.
3
Page 2 - Lori K. 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 A substantially equivalent determination assumes 895. compliance with the current Good Manufacturing Practice reguirement, 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 your device in the Federal Reqister. Please note: this 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 K. Holder, RAC
obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet 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
Page 1 of 1
510(k) Number (if known): K971523
Device Name: Distally Fixed Hip Stem RENANED; PRECEDENT REVISION HIP 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use X
OR
Over-The-Counter Use
(Optional Format 1-2-96)