(78 days)
Sentry Femoral Component: Howmedica Inc., S-ROM® Femoral Prosthesis: Joint Medical Product Corporation., Stability Hip Stem: Depuy Inc., Wagner Revision Stem: Protek Inc.
Not Found
No
The description focuses solely on the mechanical design and materials of a hip implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a hip implant intended for the treatment of various joint diseases and revision of failed arthroplasty, all of which aim to restore function and alleviate pain.
No
The device description indicates that the Precedent Revision Hip System is a physical implant (femoral stem for hip replacement) and its intended use is for surgical implantation in patients with specific degenerative joint conditions or failed previous arthroplasty. It does not perform any diagnostic function.
No
The device description clearly describes a physical implant made of titanium alloy with specific features like a neck trunnion, flutes, and a coronal slot, intended for surgical implantation. 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 and Intended Use: The description clearly states that the Precedent Revision Hip System is a physical implant (a hip stem) intended for surgical implantation into the femoral canal during total hip arthroplasty. Its purpose is to replace a damaged or failed hip joint.
- Lack of Biological Sample Analysis: There is no mention of this device being used to analyze biological samples or provide diagnostic information based on such analysis.
Therefore, the Precedent Revision Hip System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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., avascular 1. necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
-
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
-
- Revision of previously failed hip arthroplasty
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 ioint 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)
LZO
Device Description
The Precedent Revision Hip System is manufactured from either wrought or forged titanium alloy. The Precedent Revision Hip System features a threaded Sulzer 12/14 configured neck trunnion for attachment to Sulzer Orthopedics' currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore. The 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 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 pain. The distal tip of the Precedent Revision Hip System is polished to a machined finish to provide ease of insertion during surgery.
This device is intended for use with the following previously cleared devices:
- Sulzer Orthopedics metallic femoral bearing heads 체
- Sulzer Orthopedics Biolox Bearing Heads I
- 트 Sulzer Orthopedics Zirconia Bearing Heads
- Sulzer Orthopedics bipolar components
- Sulzer Orthopedics unipolar components
- 제 Sulzer Orthopedics acetabular components
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral canal, hip joint
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): 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.
Sentry Femoral Component: Howmedica Inc., S-ROM® Femoral Prosthesis: Joint Medical Product Corporation., Stability Hip Stem: Depuy Inc., Wagner Revision Stem: Protek 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
§ 888.3353 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 OF SAFETY AND EFFECTIVENESS
। రచ
OCT - 1 1997
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 without HA.
| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Date: | July 14, 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 alloy. The Precedent Revision Hip System features a threaded Sulzer 12/14 configured neck trunnion for attachment to Sulzer Orthopedics' currently marketed femoral heads, including Biolox and Zirconia heads, employing a Sulzer 12/14 configured bore. The 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 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 pain. The distal tip of the Precedent Revision Hip System is polished to a machined finish to provide ease of insertion during surgery.
This device is intended for use with the following previously cleared devices:
- Sulzer Orthopedics metallic femoral bearing heads 체
- Sulzer Orthopedics Biolox Bearing Heads I
- 트 Sulzer Orthopedics Zirconia Bearing Heads
- Sulzer Orthopedics bipolar components
- Sulzer Orthopedics unipolar components
- 제 Sulzer Orthopedics acetabular components
1
972637
2 of 2
SPECIFIC DIAGNOSTIC INDICATIONS
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., avascular 1. necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
-
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
-
- Revision of previously failed hip arthroplasty
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 ioint 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:
- 제 Sentry Femoral Component: Howmedica Inc.
- . S-ROM® Femoral Prosthesis: Joint Medical Product Corporation.
- Stability Hip Stem: Depuy Inc.
- 피 Wagner Revision Stem: Protek Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 1 -
Lori K. Holder, RAC Requlatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
K972637 Re: Precedent Revision Hip System Trade Name: (Grit Blasted) Regulatory Class: II Product Code: LZO Dated: July 14, 1997 Received: July 15, 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.
3
Page 2 - Lori K. Holder, RAC
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, 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 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
4
510(k) Number (if known): 1972637
Device Name: Precedent Revision Hip System without HA
Indications For Use:
The general indications associated with the use of the Precedent Revision Hip system without HA in total hip arthroplasty include:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction 2. persists.
-
- Revision of previously failed arthroplasty.
The Precedent Revision Hip System without HA 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)
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(Division Sign-Off) Division of General Restorative I 510(k) Number
Prescription Use X
OR
Over-The-Counter Use _
(Optional Format 1-2-96)