(51 days)
No
The submission describes hip implant components and a labeling update for MR Conditional use. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a hip system component intended to address painful and disabling joint diseases, fractures, necrosis, and arthritis, all of which are medical conditions that require treatment. Its purpose is to alleviate symptoms, restore function, and improve a patient's health, thus classifying it as a therapeutic device.
No
Explanation: This device is a component of a hip replacement system, indicated for various hip conditions. It is an implantable medical device used for treatment, not for diagnosing medical conditions.
No
The device description clearly states that the devices are physical components of a hip system (femoral head and acetabular shell), not software. The submission is for a labeling modification related to MR compatibility of these physical implants.
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 clearly describes the device as an implantable hip prosthesis component used for treating various hip conditions like fractures, necrosis, and arthritis. This is a surgical device, not a diagnostic test performed on samples outside the body.
- Device Description: The description confirms the devices are "Stryker Hip System components" which are implanted.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis or monitoring of a disease state based on such analysis.
The submission is focused on adding MR Conditional labeling to existing implantable devices, which is a safety consideration for patients with these implants undergoing MRI scans. This further reinforces that the device itself is not an IVD.
N/A
Intended Use / Indications for Use
UHR Bipolar:
· Femoral head/neck fractures or non-unions.
· Aseptic necrosis of the femoral head.
· Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
· Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
· Salvage of failed total hip arthroplasty.
Restoration GAP II Acetabular Shell:
· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
· Segmental and/or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum, using standard total hip replacement acetabular components and procedures.
Product codes
KWL, LZO, JDI
Device Description
The devices covered by this submission are Stryker Hip System components:
- UHR Bipolar femoral head
- Restoration GAP II Acetabular Shell
These devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available.
The purpose of this submission is to modify the labeling of these Stryker Hip System components to add MR Conditional labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR Imaging
Anatomical Site
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
Non-Clinical Testing:
- Magnetically Inducted Displacement Force performed per ASTM F2052-15, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment
- Magnetically Induced Torque performed per ASTM F2213-17, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the MR Environment
- . Image Artifact – performed per ASTM F2119-07 (Reapproved 2013), Standard Test Method for Evaluation of MR Image Artifacts from passive Implants
- Heating by RF Fields per ASTM F2182-19, Standard Test Method for Measurement of Radio Frequency Induced Heating near Passive Implants during MR Imaging
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
October 21, 2022
Howmedica Osteonics Corp., dba Stryker Orthopaedics Margaret Klippel Chief Specialist, Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430
Re: K222632
Trade/Device Name: UHR Bipolar Implants, Restoration GAP II Implants Regulation Number: 21 CFR 888.3360 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWL, LZO, JDI Dated: August 24, 2022 Received: August 31, 2022
Dear Margaret Klippel:
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
1
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 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 (OS) 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,
Limin Sun, Ph.D. 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
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Indications for Use
510(k) Number (if known)
Device Name UHR Bipolar
Indications for Use (Describe)
· Femoral head/neck fractures or non-unions.
· Aseptic necrosis of the femoral head.
· Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
· Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
510(k) Number (if known)
K222632
Device Name Restoration GAP II Acetabular Shell
Indications for Use (Describe)
· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
· Segmental and/or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum, using standard total hip replacement acetabular components and procedures.
| 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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
| Sponsor | Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Margaret Klippel
Chief Specialist, Regulatory Affairs
Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430
Telephone: 201-831-5559 |
| Date Prepared: | October 21, 2022 |
| Proprietary Name: | UHR Bipolar
Restoration GAP II Acetabular Shell |
| Common Name: | Artificial Hip Replacement Components |
| Regulatory Class: | Class II |
| Regulation: | Hip joint femoral (hemi-hip) metallic cemented or uncemented
prosthesis 21 CFR §888.3360 |
| | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis 21 CFR §888.3353 |
| Product Codes: | KWL – Prosthesis, hip, hemi-, femoral, metal |
| | LZO – Prosthesis, hip, semi-constrained, metal/ceramic/polymer,
cemented or non-porous, uncemented |
| | IDI – Prosthesis, hip, semi-constrained, metal/polymer, cemented |
Legally Marketed Device to Which Substantial Equivalence is Claimed:
Additional Predicate Devices
5
Device Description:
The devices covered by this submission are Stryker Hip System components:
- UHR Bipolar femoral head ●
- Restoration GAP II Acetabular Shell
These devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available.
The purpose of this submission is to modify the labeling of these Stryker Hip System components to add MR Conditional labeling.
Indication for Use:
The indications for the subject components are as follows:
UHR Bipolar:
- Femoral head/neck fractures or non-unions. ●
- Aseptic necrosis of the femoral head. ●
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular ● involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular ● procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty. ●
Restoration GAP II Acetabular Shell:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid ● arthritis, post- traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure.
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.
- Segmental and/or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum, using standard total hip replacement acetabular components and procedures.
Summary of Technological Characteristics:
There have been no changes to the technological characteristics of the subject Stryker Hip System devices as a result of the revision to the labeling. The subject devices have the same design and are manufactured from the same materials as the predicate devices.
Non-Clinical Testing:
6
The following non-clinical laboratory testing was performed to determine substantial equivalence:
- Magnetically Inducted Displacement Force performed per ASTM F2052-15, Standard Test . Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment
- Magnetically Induced Torque performed per ASTM F2213-17, Standard Test Method for ● Measurement of Magnetically Induced Torque on Medical Devices in the MR Environment
- . Image Artifact – performed per ASTM F2119-07 (Reapproved 2013), Standard Test Method for Evaluation of MR Image Artifacts from passive Implants
- Heating by RF Fields per ASTM F2182-19, Standard Test Method for Measurement of Radio . Frequency Induced Heating near Passive Implants during MR Imaging
The labeling has been modified to include the MR conditional symbol, and to provide the parameters under which a patient who has the device can be safely scanned.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
Conclusion: The Stryker Hip System components are substantially equivalent to the predicate devices identified in this premarket notification.