(78 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a hip prosthesis, with no mention of AI or ML.
Yes
The device, the Wagner Cone Prosthesis stem, is intended for use in treating degenerative and inflammatory joint diseases, and for revision of failed hip arthroplasty, which are therapeutic interventions.
No
The device described is a prosthetic implant (hip arthroplasty stem) used for treatment/repair, not for diagnosing medical conditions.
No
The device description clearly describes a physical implant (stem) with specific material properties, dimensions, and design features, 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 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: The description clearly states that this is a prosthesis stem designed for uncemented fixation in the hip joint. This is a surgically implanted device used to replace a damaged joint.
- Intended Use: The intended use describes the conditions for which the prosthesis is used (degenerative and inflammatory joint diseases, failed surgeries, revisions). These are conditions treated by replacing the joint, not by analyzing samples from the body.
The information provided describes a medical device used in surgery, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
- Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis.
- 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, LPH, KWZ, JDI
Device Description
The Wagner Cone Prosthesis stem is a straight, collarless stem system designed for uncemented fixation. The surface of the prosthesis is rough blasted, and it has a tapered shape with an angle of five degrees. The stem has eight longitudinal ribs, and it is available in two different CCD angles, 125° and 135°. The stems are available in twelve diameters, ranging from 13 to 24 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non-Clinical Performance and Conclusions:
The following tests have been completed in support of the changes to the Wagner Cone Prosthesis system: Stem and Neck Fatigue Testing, Biocompatibility Testing, and Burst Strength Testing of Ceramic Femoral Heads
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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.
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
K113556 (pg. 1 of 2)
FEB 1 7 2012
Image /page/0/Picture/2 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized letter Z inside. Below the circle, the word "zimmer" is written in a blocky, sans-serif font.
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
Summary of Safety and Effectiveness Zimmer GmbH Sponsor: Sulzerallee 8 CH-8404 Winterthur, Switzerland Contact Person: Dan Williman Associate Project Manager, Regulatory Affairs Telephone: 573-371-8065 Fax: (574) 372-4605 Date: January 17, 2012 Trade Name: Wagner Cone Prosthesis® System Product Code / Device: LZO - Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented LPH - Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented K WZ - prosthesis, hip, constrained, cemented or uncemented, metal/polymer JDI - prosthesis, hip, semi-constrained. metal/polymer, cemented Regulation Number / Description: 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis 21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis 21 CFR § 888.3310 - Hip joint metal/polymer constrained, cemented or uncemented prosthesis 21 CFR § 888.3350 - Hip joint metal polymer, semi-constrained cemented prosthesis
1
KII3556
Predicate Device:
Device Description:
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
Wagner Cone Prosthesis, manufactured by Centerpulse Orthopaedics Inc., K032380, cleared September 22, 2003
CLSTM Spotorno™ Femoral Stem, manufactured by Zimmer GmbH., K042249, cleared September 15, 2004
The Wagner Cone Prosthesis stem is a straight, collarless stem system designed for uncemented fixation. The surface of the prosthesis is rough blasted, and it has a tapered shape with an angle of five degrees. The stem has eight longitudinal ribs, and it is available in two different CCD angles, 125° and 135°. The stems are available in twelve diameters, ranging from 13 to 24 mm.
- · Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis.
- · Failed previous surgery where pain, deformity, or dysfunction persists.
- · Revision of previously failed hip arthroplasty.
The Wagner Cone Prosthesis system is similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices.
Non-Clinical Performance and Conclusions:
The following tests have been completed in support of the changes to the Wagner Cone Prosthesis system: Stem and Neck Fatigue Testing, Biocompatibility Testing, and Burst Strength Testing of Ceramic Femoral Heads
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted as a stylized bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
FEB 17 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Inc. % Mr. Dan Williman Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw. Indiana 46581-0708
Re: K113556
Trade/Device Name: Wagner Cone Prosthesis® System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, LPH, KWZ, JDI Dated: January 17, 2012 Received: January 19, 2012
Dear Mr. Williman:
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 r ou may, incressers, mains 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 If your device is classified (000 above). 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 I loast be advised that I D. I brisean that your device complies with other requirements of the Act that I Dri has made a ceteriminations administered by other Federal agencies. You must of any I catal statures and regalanchs ancluding, but not limited to: registration and listing (21
3
Page 2 - Mr. Dan Williman
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eurid Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Wagner Cone Prosthesis® System
Indications for Use:
- Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, ● osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis.
- Failed previous surgery where pain, deformity, or dysfunction persists. .
- Revision of previously failed hip arthroplasty. .
Prescription Use __X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division ign-(Division Sign-Ort), Orthepedic, Divisionative Devices
510(k) Number K113556
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