(52 days)
Not Found
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is a prosthetic replacement for a damaged part of the femur used to treat joint diseases, indicating a therapeutic purpose.
No
The device is a prosthetic implant for replacement of the proximal femur, not a diagnostic device. The "Specific diagnostic indications for use" refer to the medical conditions for which the prosthesis is indicated, not that the device itself performs diagnosis.
No
The device description clearly states it is a physical implant made of titanium-aluminum-niobium alloy, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "prosthetic replacement of the proximal portion of the femur in total hip arthroplasty." This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical characteristics of a surgical implant (titanium alloy stem, conical configuration, flutes for stability).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
The diagnostic indications listed (noninflammatory degenerative joint disease, inflammatory joint disease, failed previous surgery, revision of failed hip arthroplasty) are the conditions for which the surgical procedure using this implant is indicated, not diagnostic tests performed by the device itself.
N/A
Intended Use / Indications for Use
The Wagner Cone Prosthesis is intended for prosthetic replacement of the proximal portion of the femur in total hip arthroplasty. This device is intended for cementless application where primary fixation occurs predominantly in the distal region. Specific diagnostic indications for use of the Wagner Cone Prosthesis are:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular . 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
This stem is a titanium-aluminum-niobium alloy conical configuration with a taper. The design features a circular cross-section with eight equally spaced conical longitudinal flutes down the long axis of the stem for rotational stability. The stem's core diameter tapers gradually from the proximal end to the distal end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal portion of the femur
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)
Performance tests, design comparisons, and functional analyses conducted on the Wagner Cone Prosthesis demonstrate that it is substantially equivalent to the predicate devices.
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.
K955296, K022549, K960588, K972637
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
| SPONSOR NAME: | Centerpulse Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Robert M. Wolfarth
Phone: (512) 432-9324
E-Mail: Robert.Wolfarth@Centerpulse.com |
| TRADE NAME: | Wagner Cone Prosthesis |
| COMMON NAME: | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis |
| CLASSIFICATION: | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prostheses (Product Code 87 LZO) are Class
II per 21 CFR §888.3353, reviewed by the Orthopedic Devices panel. |
PREDICATE DEVICES:
- MP™ Reconstruction Hip Stem by Waldemar Link GmbH & Co KG. (K955296) ●
- Restoration™ Modular System by Howmedica Osteonics Corp. (K022549) ●
- Wagner Revision Stem (K960588) .
- Precedent Revision Hip Stem (K972637) .
DEVICE DESCRIPTION:
This stem is a titanium-aluminum-niobium alloy conical configuration with a taper. The design features a circular cross-section with eight equally spaced conical longitudinal flutes down the long axis of the stem for rotational stability. The stem's core diameter tapers gradually from the proximal end to the distal end.
INTENDED USE:
The Wagner Cone Prosthesis is intended for prosthetic replacement of the proximal portion of the femur in total hip arthroplasty. This device is intended for cementless application where primary fixation occurs predominantly in the distal region. Specific diagnostic indications for use of the Wagner Cone Prosthesis are:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular . 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.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Performance tests, design comparisons, and functional analyses conducted on the Wagner Cone Prosthesis demonstrate that it is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 2003
Mr. Robert M. Wolfarth Regulatory Affairs Programs Manager Centerpulse Orthopedics, Inc. 9900 Spectrum Drive Austin, TX 78717
Re: K032380 Trade/Device Name: Wagner Cone Prosthesis Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: July 30, 2003 Received: August 1, 2003
Dear Mr. Wolfarth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Robert M. Wolfarth
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark M Millham
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(K) Number.
Wagner Cone Prosthesis Device Name:
Indications for Use:
The Wagner Cone Prosthesis is intended for prosthetic replacement of the proximal portion of the femur in total hip arthroplasty. This device is intended for cementless application where primary fixation occurs predominantly in the distal region. Specific diagnostic indications for use of the Wagner Cone Prosthesis are:
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., . avascular 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. ●
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
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(Division Sign-Off)
D. ision of General, Restorative
and Neurological Devices
510(k) Number. K032380