(84 days)
Not Found
No
The document describes a hip replacement system and its components, focusing on materials, design, and MR compatibility. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is a hip joint replacement prosthesis used in total or hemi hip arthroplasty to correct severe hip pain, disability, and anatomical issues. It is a medical implant used to treat existing conditions or replace damaged body parts, falling under the definition of a therapeutic device.
No
Explanation: This device is a hip joint replacement prosthesis, which is an implant used for treating various hip conditions, not for diagnosing them. The "Intended Use / Indications for Use" section clearly outlines the conditions this device is used to rehabilitate or replace damaged hips, such as "Noninflammatory degenerative joint disease," "Failed previous surgery," and "Acute traumatic fracture." It does not mention any diagnostic capabilities. The "Device Description" also specifies it as a "hip replacement system component."
No
The device description clearly states it is a hip replacement system comprised of physical components (femoral stem and femoral head). The submission is for adding MR conditional information to the labeling of these physical devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe the device as a hip joint replacement prosthesis used for surgical implantation to treat various hip conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a hip replacement system (femoral stem and femoral head) and their function in replacing the proximal femur. This aligns with a surgical implant.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information for the diagnosis of a disease or condition in vitro.
- Focus on Surgical Intervention: The entire context revolves around surgical procedures (total or hemi hip arthroplasty) to address physical damage and dysfunction of the hip joint.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems:
· 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 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, or total hip replacement (THR)
-
· Acute traumatic fracture of the femoral head or neck
-
· Avascular necrosis of the femoral head.
-
· Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
-
· Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists.
-
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
-
· Acute traumatic fracture of the femoral head or neck.
-
· Avascular necrosis of the femoral head.
Avenir® Müller Stems are for cementless use only.
The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. · Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
· Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
· Patients with acute femoral neck fractures.
The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
- · Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- · Patients suffering from disability due to previous fusion.
- · Patients with previously failed endoprostheses and/or total hip components in the operative extremity.
- · Patients with acute neck fractures.
This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
- Noninflammatory degenerative joint disease (NID), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.
- · Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
- · Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.
This stem is for uncemented use only.
• Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· Failed previous surgery where pain, deformity, or dysfunction persists.
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
· Revision of previously failed hip arthroplasty
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH, KWZ, JDI, KWL, KWY, LWJ, MEH
Device Description
Zimmer Hip Joint Replacement Prostheses are hip replacement system components. A femoral stem component is used in conjunction with a femoral head component for replacement of the proximal femur in total hip arthroplasty. Femoral stems are available in different designs, materials, sizes, neck lengths and taper sizes. A taper is incorporated in the design of the stem to interlock it with the femoral head. Femoral head components are available in a variety of sizes and neck lengths for reconstruction of the natural head center of the femur. The purpose of this submission is the addition of MR conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions of the components, compatibility, packaging, or sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Nonclinical Performance and Conclusions: The interactions of Zimmer Hip Joint Replacement implants with static and time varying magnetic fields during Magnetic Resonance Imaging procedures have been evaluated and the subject devices have been determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. Data and scientific rationalizations to quantify the RF-induced heating, static magnetic field interactions, and image artifact generation of the Zimmer Hip Joint Replacement implants in the 1.5 Tesla (T) and 3.0 T MRI clinically relevant environments have been generated.
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.
K191781, K192416, K192236, K193030, K193050
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
April 10, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Zimmer GmbH Anne-Kathrin Born Regulatory Affairs Senior Specialist Sulzer Allee 6 Winterthur. 8404 Ch
Re: K200112
Trade/Device Name: Zimmer Hip Joint Replacement 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, KWL, KWY, LWJ, MEH Dated: February 6, 2020 Received: February 12, 2020
Dear Anne-Kathrin Born:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K200112
Device Name
Alloclassic® Zweymüller® SL / SL Offset Femoral Stems
Indications for Use (Describe)
Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems:
· Noninflammatory degenerative joint disease (NID), 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
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
510(k) Number (if known) K200112
Device Name Avenir® Cemented Hip Stem
Indications for Use (Describe)
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, or total hip replacement (THR)
- · Acute traumatic fracture of the femoral head or neck
- · Avascular necrosis of the femoral head.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known) K200112
Device Name Avenir® Müller Stem
Indications for Use (Describe)
- · Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
- · Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists.
- · Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
- · Acute traumatic fracture of the femoral head or neck.
- · Avascular necrosis of the femoral head.
Avenir® Müller Stems are for cementless use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K200112
Device Name BIOLOX® delta Ceramic Femoral Head
Indications for Use (Describe)
The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis,
polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. · Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
· Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
· Patients with acute femoral neck fractures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known) K200112
Device Name
BIOLOX® OPTION Ceramic Femoral Head System
The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis,
polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
- · Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- · Patients suffering from disability due to previous fusion.
- · Patients with previously failed endoprostheses and/or total hip components in the operative extremity.
- · Patients with acute neck fractures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
510(k) Number (if known) K200112
Device Name Fitmore® Hip Stem
| Indications for Use (Describe) |
|---|
| -------------------------------- |
- This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
- Noninflammatory degenerative joint disease (NID), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.
- · Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
- · Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.
This stem is for uncemented use only.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
8
510(k) Number (if known) K200112
Device Name Wagner Cone Prosthesis
• Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· Failed previous surgery where pain, deformity, or dysfunction persists.
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
9
510(k) Number (if known) K200112
Device Name Wagner SL Revision Stem Lateral
Indications for Use (Describe)
· Revision of previously failed hip arthroplasty
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
10
Image /page/10/Picture/0 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a white "Z" inside it, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is also blue, and the logo is clean and modern.
510(k) Summary
| Sponsor: | Zimmer GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anne-Kathrin Born, Regulatory Affairs
Telephone: +41 58 854 86 19
Fax: + 41 52 244 86 58 |
| Date: | April 02, 2020 |
| Trade Name: | Zimmer Hip Joint Replacement |
| Common Name: | Hip Prosthesis |
| Classification Name: | LZO - Prosthesis, hip, semi-constrained, metal/ceramic/polymer,
cemented or non-porous, uncemented (21 CFR §888.3353).
LPH - Prosthesis, hip, semi-constrained, metal/polymer, porous
uncemented (21 CFR §888.3358).
KWZ - Prosthesis, hip, constrained, cemented or uncemented,
metal/polymer (21 CFR §888.3310).
JDI - Prosthesis, hip, semi-constrained, metal/polymer, cemented
(21 CFR §888.3350).
KWL - Prosthesis, hip, hemi-, femoral, metal (21 CFR §888.3360).
KWY - Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or
uncemented (21 CFR §888.3390).
LWJ - Prosthesis, hip, semi-constrained, metal/polymer,
uncemented (21 CFR §888.3360).
MEH - Prosthesis, Hip, Semi-Constrained, Uncemented,
Metal/Polymer, Non-Porous, Calcium Phosphate (21 CFR
§888.3353). |
| Predicate Devices: | Wagner SL Revision Stem Lateral, manufactured by Zimmer
GmbH, K191781, cleared August 06, 2019
Wagner Cone Prosthesis System, manufactured by Zimmer
GmbH, K191781, cleared August 06, 2019
Biolox Delta Ceramic Femoral Heads, manufactured by Zimmer
GmbH, K192416, cleared October 01, 2019
Biolox Option Ceramic Femoral Head System, manufactured by
Zimmer GmbH, K192416, cleared October 01, 2019
Fitmore® Hip Stem, manufactured by Zimmer GmbH, K192236,
cleared November 5, 2019 |
11
Image /page/11/Picture/0 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is also in blue, matching the color of the circle and "Z" symbol. The logo appears to be clean and modern, representing the company's brand identity.
| Avenir® Cemented Hip Stem, manufactured by Zimmer GmbH, K193030, cleared December 6, 2019 | |
|---|---|
| Avenir® Müller Stem, manufactured by Zimmer GmbH, K193030, cleared December 6, 2019 | |
| Alloclassic® Zweymüller® SL Femoral Stem, manufactured by Zimmer GmbH, K193050, cleared December 26, 2019 | |
| Alloclassic® Zweymüller® SL Offset Femoral Stem, manufactured by Zimmer GmbH, K193050, cleared December 26, 2019 | |
| Device Description: | Zimmer Hip Joint Replacement Prostheses are hip replacement system components. A femoral stem component is used in conjunction with a femoral head component for replacement of the proximal femur in total hip arthroplasty. Femoral stems are available in different designs, materials, sizes, neck lengths and taper sizes. A taper is incorporated in the design of the stem to interlock it with the femoral head. Femoral head components are available in a variety of sizes and neck lengths for reconstruction of the natural head center of the femur. The purpose of this submission is the addition of MR conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions of the components, compatibility, packaging, or sterilization. |
| Indications for Use: | Wagner Cone Prosthesis are indicated for: 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.Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. |
| Wagner SL Revision Stem Lateral is indicated for: Revision of previously failed hip arthroplasty. | |
| The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur |
femur.
- Patients with congenital hip dysplasia, protrusio acetabuli, .
12
Image /page/12/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is also in blue, matching the color of the circle and the "Z" symbol.
or slipped capital femoral epiphysis.
- . Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
- . Patients with acute femoral neck fractures.
The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
- Patients suffering from severe hip pain and disability due to . rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
- o Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- . Patients suffering from disability due to previous fusion.
- Patients with previously failed endoprostheses and/or total . hip components in the operative extremity.
- . Patients with acute neck fractures.
The Fitmore® Hip Stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
- Noninflammatory degenerative joint disease (NIDJD), e. . g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.
- . Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
- Optional use in revision: in some medical conditions (e. g., o early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.
- This stem is for uncemented use only.
Avenir® Müller Stem is intended for:
- o Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases.
- . Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists.
- . Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
- . Acute traumatic fracture of the femoral head or neck.
- . Avascular necrosis of the femoral head.
Avenir® Müller Stems are for cementless use only.
13
Image /page/13/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is also in blue, matching the color of the circle and the "Z" symbol.
The Avenir® Cemented Hip Stem 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 ioint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR)
- . Acute traumatic fracture of the femoral head or neck
- o Avascular necrosis of the femoral head.
Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems are indicated for:
- . Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.q., rheumatoid arthritis.
- . Failed previous surgery where pain, deformity, or dysfunction persists.
- . Revision of previously failed hip arthroplasty.
Comparison to Predicate Device: The subject devices have the same intended use and are substantially equivalent to the legally marketed predicated devices. Performance Data (Nonclinical Non-Clinical Performance and Conclusions: and/or Clinical): The interactions of Zimmer Hip Joint Replacement implants with static and time varying magnetic fields during Magnetic Resonance Imaging procedures have been evaluated and the subject devices have been determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. Data and scientific rationalizations to quantify the
RF-induced heating, static magnetic field interactions, and image artifact generation of the Zimmer Hip Joint Replacement implants in the 1.5 Tesla (T) and 3.0 T MRI clinically relevant environments have been generated.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Conclusion: The subject devices have the same intended use and similar indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using the same materials and processes as the predicate devices. Except for the modifications described in this submission the
subject devices are identical to the predicate devices, and the performance data and analyses demonstrate that:
14
Image /page/14/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The color of the text is a dark gray or blue, matching the color of the "Z" symbol.
- any differences do not raise new questions of safety and ● effectiveness as established with performance testing; and
- . the subject devices are at least as safe and effective as the legally marketed predicate devices