(58 days)
No
The document describes a mechanical hip implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
This device is a femoral hip prosthesis intended for total or hemi hip arthroplasty to rehabilitate damaged hips, which is a therapeutic intervention.
No
Explanation: The device described is a femoral hip prosthesis, which is an implant used for hip arthroplasty, not for diagnosing medical conditions.
No
The device description clearly states it is a "femoral hip prosthesis" and a "straight, doubletapered stem manufactured from Protasul - S30 stainless steel material," indicating it is a physical implant, 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 describes a surgical implant for hip replacement, addressing structural damage to the hip joint. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a "femoral hip prosthesis," a physical implant designed to replace a damaged part of the femur.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Avenir Cemented Hip Stem is a femoral hip prosthesis that is designed for cemented fixation into the intramedullary canal for pathological or degenerative conditions involving the femur that merit total or hemi hip arthroplasty.
The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:
- Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases
- Failed previous hip surgery including joint reconstruction (osteotomy). arthrodesis, hemiarthroplasty or total hip replacement (THR)
- Acute traumatic fracture of the femoral head or neck
- Avascular necrosis of the femoral head.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LWJ, KWL, KWL, KWZ, KWY
Device Description
The Avenir Cemented Hip Stem is a straight, doubletapered stem manufactured from Protasul - S30 stainless steel material. The tapered aspects of the stem match the Avenir-Müller Stem, and promotes self-locking of the stem within the femoral canal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing/analysis included: Accelerated Corrosion Fatigue Test, Proximal & Mid-Stem Fatigue Testing, Pull-off Strength testing and rationale, summary of Burst Strength Testing and Range of Motion analysis.
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.
K993043, K001078, K020713, K040803
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.
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
Image /page/0/Picture/0 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 stylized font.
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Names . and References:
Classification Panel:
Predicate Device(s):
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
K131884
510(k) Summary
Zimmer, GmbH Sulzer Allee 8 Winterthur CH-8404 Switzerland
AUG 2 2 2013
Karen O'Leary Senior Specialist, Regulatory Affairs Telephone: (574) 371-8515 Fax: (574) 372-4605
24 June 2013
Avenir® Cemented Hip Stem
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented
21 CFR §888.3353 - LZO - Prosthesis, hip, semiconstrained, metal/ceramic/polymer, cemented or non-porous, uncemented
21 CFR 8888.3360 - LWJ - Prosthesis, hip, semiconstrained, metal/polymer, uncemented
21 CFR $888.3360 - KWL - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
21 CFR &88.3310 - KWZ - prosthesis, hip, constrained, cemented or uncemented, metal/polymer
21 CFR §888.3390 - KWY - prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Orthopedics/87
MS-30® Hip Prosthesis, manufactured by Zimmer GmbH,
- K993043, cleared December 2, 1999 .
- K001078, cleared June 23, 2000 ●
- K020713, cleared May 14, 2002 .
- K040803, cleared April 29, 2004 .
1
K131884
Avenir® Müller Cementless Hip Stem, manufactured by Zimmer GmbH
· K123392, cleared March 4, 2013
The Avenir Cemented Hip Stem is a femoral hip prosthesis that is designed for cemented fixation into the intramedullary canal for pathological or degenerative conditions involving the femur that merit total or hemi hip arthroplasty.
The Avenir Cemented Hip Stem is a straight, doubletapered stem manufactured from Protasul - S30 stainless steel material. The tapered aspects of the stem match the Avenir-Müller Stem, and promotes self-locking of the stem within the femoral canal.
The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:
- Advanced wear of the joint due to degenerative, post-. traumatic, or rheumatic diseases
- Failed previous hip surgery including . joint reconstruction (osteotomy). arthrodesis, hemiarthroplasty or total hip replacement (THR)
- Acute traumatic fracture of the femoral head or neck .
- Avascular necrosis of the femoral head. .
The Avenir® Cemented Stem is similar in intended use, materials, sterility and performance characteristics to the predicate device(s).
Non-Clinical Performance and Conclusions:
The results of non-clinical (lab) performance testing demonstrate the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing/analysis included: Accelerated Corrosion Fatigue Test, Proximal & Mid-Stem Fatigue Testing, Pull-off Strength testing and rationale, summary of Burst Strength Testing and Range of Motion analysis.
Purpose and Device Description:
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
2
·
.
.
.
.
.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
.
. . . . .
:
l
,
. . . . .
.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a single snake entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
Zimmer GmbH Ms. Karen O'Leary Senior Specialist, Regulatory Affairs Zimmer Incorporated P.O. Box 708 Warsaw, Indiana 46581
Re: K131884
Trade/Device Name: Avenir® Cemented Hip Stem 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, LWJ, KWL, KWL, KWZ, KWY Dated: June 24, 2013 Received: June 25, 2013
Dear Ms. O'Leary:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 - Ms. Karen O'Leary
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131884
Device Name:
Avenir® Cemented Hip Stem
Indications for Use:
The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:
- Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases ●
- Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, ● hemiarthroplasty or total hip replacement (THR)
- Acute traumatic fracture of the femoral head or neck ●
- Avascular necrosis of the femoral head. .
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)
Elizabeth L. Frank -S
Page 1 of 1
Division of Orthopedic Devices
37