(90 days)
APR and Natural Hip Systems
Not Found
No
The summary describes a mechanical implant (femoral stems and ceramic heads) for hip replacement surgery. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies mentioned are mechanical tests.
Yes
The device is a femoral stem and ceramic head used for prosthetic replacement in total hip arthroplasty, addressing conditions like degenerative joint disease and failed previous surgeries, which are therapeutic interventions.
No
Explanation: The device is a femoral stem and head for prosthetic replacement during hip arthroplasty, which is a therapeutic device, not a diagnostic one. While it mentions "specific diagnostic indications" for patient conditions for which the device can be used, the device itself does not perform diagnosis.
No
The device description clearly details physical components made of Ti-6A1-7Nb alloy and Zirconia Ceramic, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant – a femoral stem and ceramic head intended for prosthetic replacement of the hip joint. This is a device that is surgically placed inside the body, not used to test samples outside the body.
- Intended Use: The intended use clearly states it's for "prosthetic replacement of the proximal portion of the femur during total hip arthroplasty." This is a surgical procedure, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, using reagents, or providing diagnostic results based on laboratory tests.
Therefore, based on the provided information, this device is a medical device (specifically, a surgical implant), but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CLS, Wagner Revision and AlloClassic Zweymuller femoral stems will be used in conjunction with the Zirconia Ceramic Total Head. This stem/head combination is intended for prosthetic replacement of the proximal portion of the femur during total hip arthroplasty in which the ball head articulates with a polyethylene acetabular component. Specific diagnostic indications include:
- Patient conditions of inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis);
- Those patients with failed previous surgery where pain, deformity, or dysfunction persist; and,
- Revision of previously failed hip arthroplasty.
The CLS Stem, Wagner Revision Stem and AlloClassic Zweymuller Stem are intended for use with or without bone cement.
Product codes
LZO
Device Description
The CLS Stem. Wagner Revision Stem and AlloClassic Zweymuller Stem are all designed for use with ceramic heads. These stems are manufactured from Ti-6A1-7Nb alloy and have the same proximal taper which is machined per the specifications of the 12/14 Sulzer taper.
The Zirconia Ceramic Total Head is a spherical head with a 12/14 taper, making it compatible with the above stems. The heads are available in 28mm and 32mm diameters and three neck lengths; short, medium and long.
Static compression testing demonstrated that the burst strength of the zirconia heads exceeds FDA requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal portion of the femur, hip
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)
Static compression testing demonstrated that the burst strength of the zirconia heads exceeds FDA requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
APR and Natural Hip Systems
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 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 use of zirconia ceramic heads with the femoral stems listed below.
| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 30, 1997 |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis, 21 CFR 888.3353 |
| Common/Usual Name: | Total Hip Prosthesis, Semi-constrained |
| Trade/Proprietary Name: | Zirconia Ceramic Total Head (12/14) for use with the CLS
Stem, Wagner Revision Stem, and, AlloClassic Zweymuller
Stem SL |
SPECIFIC DIAGNOSTIC INDICATIONS
The CLS, Wagner Revision and AlloClassic Zweymuller femoral stems will be used in conjunction with the Zirconia Ceramic Total Head. This stem/head combination is intended for prosthetic replacement of the proximal portion of the femur during total hip arthroplasty in which the ball head articulates with a polyethylene acetabular component. Specific diagnostic indications include:
- Patient conditions of inflammatory degenerative joint disease (e.g., rheumatoid . arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis):
- . Those patients with failed previous surgery where pain, deformity, or dysfunction persist; and,
- Revision of previously failed hip arthroplasty. ●
The CLS Stem. Wagner Revision Stem and AlloClassic Zwevmuller Stem, are intended for use with or without bone cement.
PRODUCT DESCRIPTION
The CLS Stem. Wagner Revision Stem and AlloClassic Zwevmuller Stem are all designed for use with ceramic heads. These stems are manufactured from Ti-6A1-7Nb alloy and have the same proximal taper which is machined per the specifications of the 12/14 Sulzer taper.
The Zirconia Ceramic Total Head is a spherical head with a 12/14 taper, making it compatible with the above stems. The heads are available in 28mm and 32mm diameters and three neck lengths; short, medium and long.
Static compression testing demonstrated that the burst strength of the zirconia heads exceeds FDA requirements.
SUBSTANTIAL EQUIVALENCE
The CLS Stem, the Wagner Revision Stem, and the AlloClassic Zweymuller Stem when used with the Zirconia Ceramic Total Head are substantially equivalent to the APR and Natural Hip Systems (Sulzer Orthopedics Inc.).
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Shavawn Evans Parduhn ·Regulatory Affairs Specialist Sulzer Orthopedics Inc. 9900 Spectrum Drive Ausitn, Texas 78717
K973837 Re : CLS Stem, Wagner Revision Stem, AlloClassic Zweymuller Stem, SL for use with Zirconia Ceramic Heads Regulatory Class: II Product Code: LZO October 7, 1997 Dated: Received: October 8, 1997
Dear Ms. Parduhn
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 and the following limitation that the package insert must reflect that the Metoxit Zirconia Ceramic Femoral Heads are to be used only with Ti-6Al-7Nb hip stems with the Sulzer 12/14 (5°38' cone angle) Morse taper trunnions.
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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug
2
Page 2 - Ms. Shavawn Evans Parduhn
Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 Requlations.
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 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
3
Page 1 of 1
510(k) Number (if known):
Device Name: CLS Stem, Wagner Revision Stem and AlloClassic Zweymuller Stem for Use With Zirconia Ceramic Total Heads
Indications For Use:
The CLS, Wagner Revision and AlloClassic Zweymuller femoral stems will be used in conjunction with the Zirconia Ceramic Total Head. This stem/head combination is intended for prosthetic replacement of the proximal portion of the femur during total hip arthroplasty in which the ball head articulates with a polyethylene acetabular component. Specific diagnostic indications include:
- Patient conditions of inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and . noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis);
- Those patients with failed previous surgery where pain, deformity, or dysfunction persist; and, .
- Revision of previously failed hip arthroplasty. .
The CLS Stem, Wagner Revision Stem and AlloClassic Zweymuller Stem are intended for use with or 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
(Optional Format 1-2-96)
correpa
Division Sign-Om
ision
n-
Division of General Restorative Devices
510(k) Number
510(k) Number K973837