(101 days)
No
The document describes hip joint prostheses and their MR conditional labeling. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, a hip replacement system, is used to treat severe hip pain and disability due to various medical conditions, aiming to rehabilitate and improve a patient's physical function.
No
This device is a hip implant system, which is a prosthetic device used for surgical replacement of hip joints. Its intended use is therapeutic, aimed at alleviating pain and disability caused by various hip conditions, not for diagnosing them. The device description explicitly states it is a "hip replacement system."
No
The device description clearly states that the devices are "hip replacement system components" consisting of "femoral stems, femoral heads, acetabular shells, acetabular liners, and other ancillary components." These are physical hardware components, not software. The submission is for adding MR conditional labeling to these physical devices.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a hip replacement system used to treat various conditions affecting the hip joint, such as arthritis, fractures, and deformities. This is a surgical implant used in vivo (within the body).
- Device Description: The description confirms the device is a hip replacement system consisting of components like femoral stems, heads, and acetabular parts. These are physical implants.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples.
- Focus on Surgical Implantation: The entire context revolves around surgically implanting components into the hip joint.
The mention of "MR conditional labeling" and "Magnetic Resonance Imaging (MRI)" relates to the device's compatibility with MRI procedures after implantation, not to the device itself being an IVD.
N/A
Intended Use / Indications for Use
- Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Epsilon Acetabular System:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, posttraumatic arthritis, or avascular necrosis and inflammatory degenerative 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
- Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
- Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Epsilon Acetabular System Constrained:
- Primary or revision total hip arthroplasties where is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intents for whom all other options to constrained acetabular components have been considered. The acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.
- Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Trabecular Revision System Cage:
- This device is indicated for patients with conditions of, but not limited to:
- Acetabular dysplasia, osteoporosis, protrusio acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.
- Advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis.
- Failed previous surgery, e.g., osteosynthesis, joint reconstruction, arthrodesis, or total hip replacement.
- This device is indicated for patients with conditions of, but not limited to:
- Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Trabecular Metal Primary Hip Prosthesis:
- Total hip replacement for the following: severe hip pain and disability due to rheumatism arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute fractures.
- Hemi-hip replacement for the following: fracture dislocation of the hip; debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
- Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Zimmer Continuum and Trilogy IT Acetabular System:
- The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
- The system is intended for use either with or without bone cement in total hip arthroplasty.
- Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Zimmer Continuum and Trilogy IT Longevity IT Constrained Liners:
- The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.
- Zimmer, Inc. Hip Joint Prostheses MR Labeling I - ZMR Hip System:
- The ZMR Hip System is indicated for cementless revision hip arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.
- Zimmer, Inc. Hip Joint Prostheses MR Labeling I - CPT Hip System:
- The CPT Hip System is indicated for cemented use in:
- 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 affected extremity.
- Patients with acute femoral neck fractures.
- The CPT Hip System is indicated for cemented use in:
- Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Zimmer Biomet Ceramic Heads:
- The Zimmer Biomet Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- When used with constrained acetabular liners, the Zimmer Biomet Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
- Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Zimmer M/L Taper Hip Prosthesis:
- Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
- Hemi-hip replacement for the following: fracture dislocation of the hip; debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
- The M/L Taper femoral stem is for cementless use only.
Product codes
JDI, KWY, KWZ, LPH, LWJ, LZO, OQG, OQH, OQI
Device Description
Zimmer Hip Joint Prostheses are hip replacement system components. The devices are modular and consist of femoral stems, femoral heads, acetabular shells, acetabular liners, and other ancillary components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Hip Joint
Indicated Patient Age Range
Skeletally mature individuals.
Younger patients consideration where an unequivocal indication outweighs risks associated with age and modified demands regarding activity and hip joint loading are assured.
Aged patients for certain fractures.
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 Tests: Zimmer has performed non-clinical Magnetic Resonance Imaging (MRI) studies on implants which are 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. MR Tests included the following: RF-induced heating (ASTM F2182-11a) Image Artifact (ASTM F2119-07) Magnetic Displacement (ASTM 2052-14) Clinical Tests: Clinical test data is not provided for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K191735, K051491, K192660, K113296, K181171, K972393, K983509, K993259, K030923, K061226, K091508, K093846, K101229, K103662, K120370, K101730
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
July 9, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Zimmer, Inc. Caleb Barylski Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46861-0708
Re: K200823
Trade/Device Name: Zimmer. Inc. Hip Joint Prostheses MR Labeling I Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI Dated: March 27, 2020 Received: March 30, 2020
Dear Caleb Barylski:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Vesa Vuniqi 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 List of cleared devices in K200823
2
List of cleared devices in K200823
-
- CPT Hip System MR Conditional
- Trabecular Metal Primary Hip Prosthesis MR Conditional 2.
-
- Zimmer M/L Taper Hip Prosthesis MR Conditional
-
- ZMR Hip System MR Conditional
-
- Zimmer Biomet Ceramic Heads MR Conditional
-
- Epsilon Acetabular System MR Conditional
- Inter-Op HA Porous Acetabular System (HA/CSTi)
- Inter-Op Acetabular System Durasul Acetabular Insert ●
- Inter-Op Durasul Acetabular Inserts/CoCr Femoral Heads .
- Epsilon Durasul Constrained Acetabular Liner .
- Trabecular Metal Acetabular Revision System Cage MR Conditional 7.
-
- Zimmer Continuum and Trilogy IT Acetabular System – MR Conditional
- Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System ●
- Longevity IT Highly Crosslinked Polyethylene Elevated Liners
- Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System ● and Trilogy Integrated Taper
- Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly . Crosslinked Polyethylene Elevated Liners
- Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners ●
-
- Zimmer Continuum and Trilogy IT Longevity IT Constrained Liners MR Conditional
- Longevity IT Highly Crosslinked Polyethylene Liners ●
3
510(k) Number (if known) K200823
Device Name
Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Epsilon Acetabular System
Indications for Use (Describe)
-
· Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis,
posttraumatic arthritis, or avascular necrosis and inflammatory degenerative 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
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
| 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) K200823
Device Name
Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Epsilon Acetabular System Constrained
Indications for Use (Describe)
Primary or revision total hip arthroplasties where is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intents for whom all other options to constrained acetabular components have been considered. The acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.
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
5
510(k) Number (if known) K200823
Device Name
Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Trabecular Revision System Cage
Indications for Use (Describe)
This device is indicated for patients with conditions of, but not limited to:
· Acetabular dysplasia, osteoporosis, protrusio acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.
· Advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis.
· Failed previous surgery, e.g., osteosynthesis, joint reconstruction, arthrodesis, or total hip replacement.
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
6
510(k) Number (if known) K200823
Device Name
Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Trabecular Metal Primary Hip Prosthesis
Indications for Use (Describe)
Total hip replacement for the following: severe hip pain and disability due to theumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonumion of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
| 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
7
510(k) Number (if known)
Device Name
Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Zimmer Continuum and Trilogy IT Acetabular System
Indications for Use (Describe)
The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The system is intended for use either with or without bone cement in total 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
8
510(k) Number (if known) K200823
Device Name
Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Zimmer Continuum and Trilogy IT Longevity IT Constrained Liners
Indications for Use (Describe)
The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.
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
9
510(k) Number (if known) K200823
Device Name
Zimmer, Inc. Hip Joint Prostheses MR Labeling I - ZMR Hip System
Indications for Use (Describe)
The ZMR Hip System is indicated for cementless revision hip arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.
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
510(k) Number (if known) K200823
Device Name
Zimmer, Inc. Hip Joint Prostheses MR Labeling I - CPT Hip System
Indications for Use (Describe)
The CPT Hip System is indicated for cemented use in:
-
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 affected 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
11
510(k) Number (if known)
Device Name
Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Zimmer Biomet Ceramic Heads
Indications for Use (Describe)
The Zimmer Biomet Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
When used with constrained acetabular liners, the Zimmer Biomet Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
| 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
12
510(k) Number (if known) K200823
Device Name
Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Zimmer M/L Taper Hip Prosthesis
Indications for Use (Describe)
Total hip replacement for the following: severe hip pain and disability due to theumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonumion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
The M/L Taper femoral stem is 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)
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510(k) Summary
| In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following
information is provided for the Zimmer, Inc. Hip Joint Prosthesis MR Labeling I 510(k) premarket
notification. The submission was prepared in accordance with the FDA guidance document,
| ‘Format for Traditional and Abbreviated 510(k)s,' issued on September 13, 2019. | Predicate Device(s) | or nonporous uncemented prosthesis (21 CFR 888.3353) | Reference: | ||
|---|---|---|---|---|---|
| Manufacturer/Submitter | Zimmer, Inc. | ||||
| P.O. Box 708 | |||||
| Warsaw, IN 46581-0708 | Primary Predicate: | ||||
| CPT Hip System (K191735, 03/20/2020) | Zimmer M/L Taper Hip Prosthesis With Kinectiv Technology MR | ||||
| Contact Person | Name: Caleb Barylski | ||||
| Phone: 574-371-0250 | |||||
| Email: Caleb.Barylski@zimmerbiomet.com | Secondary Predicates: | Labeling (K182678, 05/31/2019) | |||
| Date Prepared | July 9, 2020 | Femoral Stems | |||
| Trabecular Metal Primary Hip Prosthesis (K051491, 06/30/2005) | |||||
| Zimmer M/L Taper Hip Prosthesis (K192660, 02/28/2020) | |||||
| ZMR Hip System (K113296, 09/14/2012) | Device Description | Zimmer Hip Joint Prostheses are hip replacement system | |||
| components. The devices are modular and consist of femoral stems, | |||||
| femoral heads, acetabular shells, acetabular liners, and other ancillary | |||||
| components. The purpose of this submission is the addition of MR | |||||
| conditional labeling to the IFU and device package label of the | |||||
| subject 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. | |||||
| Subject Device | Trade Name: Zimmer, Inc. Hip Joint Prostheses MR Labeling I |
Common Name: Hip Prosthesis
Class: II
Product Codes/Regulation Description:
JDI - Hip joint metal/polymer semi-constrained cemented prosthesis
(21 CFR 888.3350)
KWY - Hip joint femoral (hemi-hip) metal/polymer cemented or
uncemented prosthesis (21 CFR 888.3390)
KWZ - Hip joint metal/polymer constrained cemented or uncemented
prosthesis (21 CFR 888.3310)
LPH - Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis (21 CFR 888.3358)
LWJ - Hip joint femoral (hemi-hip) metallic cemented or
uncemented prosthesis (21 CFR 888.3360)
LZO - Hip joint metal/ceramic/polymer semi-constrained cemented
or nonporous uncemented prosthesis (21 CFR 888.3353)
OQG - Hip joint metal/polymer/metal semi-constrained porous-
coated uncemented prosthesis (21 CFR 888.3358)
OQH - Hip joint metal/polymer semi-constrained cemented
prosthesis (21 CFR 888.3350)
OQI - Hip joint metal/ceramic/polymer semi-constrained cemented | | Femoral Heads
Zimmer Biomet Ceramic Heads (K181171, 04/02/2019) | Indications for Use | CPT Hip System |
| | Acetabular Components
Epsilon Acetabular System
• Inter-Op HA Porous Acetabular System (HA/CSTi) (K972393, 09/19/1997)
• Inter-Op Acetabular System – Durasul Acetabular Insert (K983509, 02/03/1999)
• Inter-Op Durasul Acetabular Inserts/CoCr Femoral Heads (K993259, 03/10/2000)
• Epsilon Durasul Constrained Acetabular Liner (K030923, 10/03/2003) | | The CPT Hip System is indicated for cemented use in:
– 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.
– 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 affected extremity.
– Patients with acute femoral neck fractures. | | |
| | Trabecular Metal Acetabular Revision System Cage (K061226, 08/02/2006) | | Epsilon Acetabular System
• Patient conditions of noninflammatory degenerative joint disease
(NIDJD), e.g., osteoarthritis,
posttraumatic arthritis, or avascular necrosis and inflammatory
degenerative joint disease (IJD),
e.g., rheumatoid arthritis | | |
| | Zimmer Continuum and Trilogy IT Acetabular System
• Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System (K091508, 09/11/2009)
• Longevity IT Highly Crosslinked Polyethylene Elevated Liners (K093846, 02/04/2010)
• Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper (K101229, 12/03/2010)
• Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly Crosslinked Polyethylene Elevated Liners (K103662, 04/15/2011)
• Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners (K120370, 06/04/2012) | | • Those patients with failed previous surgery where pain, deformity,
or dysfunction persists
• Revision of previously failed hip arthroplasty | | |
| | Zimmer Continuum and Trilogy IT Longevity IT Constrained Liners
• Longevity IT Highly Crosslinked Polyethylene Liners (K101730, 12/03/2010) | | Total hip replacements may be considered for younger patients if any
unequivocal indication outweighs the risks associated with the age of
the patient and modified demands regarding activity and hip joint
loading are assured. This includes severely crippled patients with
multiple joint involvement, for whom an immediate need of hip
mobility leads to an expectation of significant improvement in the
quality of their lives. | | |
| | Epsilon Acetabular System Constrained
Primary or revision total hip arthroplasties where there is a high risk
of hip dislocation due to a history of instability, bone loss, joint, | | | | |
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| for patients for whom all other options to constrained acetabular
components have been considered. The fixation method of the
acetabular components with which this device is intended to be used
is porous cementless with supplemental screws, and the fixation
method of the femoral components with which this device is intended
to be used is cemented, porous cementless, or non-porous cementless
| fixation, as indicated for use by each respective femoral component. | |
|---|---|
| Trabecular Metal Acetabular Revision System Cage | |
| This device is indicated for patients with conditions of, but not | |
| limited to: | |
| • Acetabular dysplasia, osteoporosis, protrusio acetabuli, cystic | |
| acetabular roof, reconstruction in cases of defects after fracture, | |
| acetabular loosening, tumors or revision surgery. | |
| • Advanced joint destruction resulting from degenerative, post- | |
| traumatic, or rheumatoid arthritis. | |
| • Failed previous surgery, e.g., osteosynthesis, joint reconstruction, | |
| arthrodesis, hemi-arthroplasty, or total hip replacement. | |
| Trabecular Metal Primary Hip Prosthesis | |
| Total hip replacement for the following: severe hip pain and | |
| disability due to rheumatoid arthritis, osteoarthritis, traumatic | |
| arthritis, polyarthritis, collagen disorders, avascular necrosis of the | |
| femoral head, nonunion of previous fractures of the femur; | |
| congenital hip dysplasia, protrusio acetabuli, slipped capital femoral | |
| epiphysis; disability due to previous fusion; previously failed | |
| endoprostheses, and/or total hip components in the affected extremity | |
| and acute femoral neck fractures. | |
| Hemi-hip replacement for the following: fracture dislocation of the | |
| hip; elderly, debilitated patients when a total hip replacement is | |
| contraindicated; irreducible fractures in which adequate fixation | |
| cannot be obtained; certain high subcapital fractures and comminuted | |
| femoral neck fractures in the aged; nonunion of femoral neck | |
| fractures; secondary avascular necrosis of the femoral head; | |
| pathological fractures of the femoral neck; and osteoarthritis in which | |
| the femoral head is primarily affected. | |
| Zimmer Biomet Ceramic Heads | |
| The Zimmer Biomet Ceramic Heads are indicated for the following | |
| conditions: (1) a severely painful and/or disabled hip joint as a result | |
| of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or | |
| congenital hip dysplasia, (2) avascular necrosis of the femoral head, | |
| (3) acute traumatic fracture of the femoral head or neck, (4) failed | |
| previous hip surgery including joint reconstruction, internal fixation, | |
| arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or | |
| total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. | |
| When used with constrained acetabular liners, the Zimmer Biomet Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. | |
| Zimmer Continuum and Trilogy IT Acetabular System | |
| The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. | |
| The system is intended for use either with or without bone cement in total hip arthroplasty. | |
| Zimmer Continuum and Trilogy IT Longevity IT Constrained Liners | |
| The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. | |
| Zimmer M/L Taper Hip Prosthesis | |
| Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. | |
| Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted | |
| femoral neck fractures in the aged; nonunion of femoral neck | |
| fractures; secondary avascular necrosis of the femoral head; | |
| pathological fractures of the femoral neck; and osteoarthritis in which | |
| the femoral head is primarily affected. |
The M/L Taper femoral stem is for cementless use only
ZMR Hip System
The ZMR Hip System is indicated for cementless revision hip
arthroplasty. Arthroplasty should be performed only when more
conservative methods of treatment have failed to provide
symptomatic relief or when there is progressive disability. |
| Summary of
Technological
Characteristics | The purpose of this submission is to update the Zimmer Hip Joint
Replacement Prostheses Instructions for Use precaution section to
include MR Conditional labeling along with the addition of the MR
Conditional symbol to the device package label. The addition of MR
labeling to the subject devices does not impact indications, materials,
design features or dimensions, packaging, or sterilization. The
subject devices are intended for use in hip arthroplasty. |
| Summary of
Performance Data to
Support Substantial
Equivalence
(Nonclinical and/or
Clinical) | Non-Clinical Tests:
Zimmer has performed non-clinical Magnetic Resonance Imaging
(MRI) studies on implants which are 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. MR Tests included the following:
RF-induced heating (ASTM F2182-11a) Image Artifact (ASTM F2119-07) Magnetic Displacement (ASTM 2052-14) Clinical Tests:
Clinical test data is not provided for the subject device. |
| Substantial Equivalence
Conclusion | Non-clinical tests provided in this Traditional 510(k) establish the
conditional safety and compatibility of the passive implants in a
magnetic resonance (MR) environment. The subject devices are
substantially equivalent to the legally marketed predicated devices. |
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