(198 days)
No
The summary describes a modular orthopedic implant system and its intended use and testing for compatibility in an MR environment. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No
The device is a prosthesis used for bone replacement due to radical bone loss from oncology, trauma, or failed previous prostheses, rather than actively treating a disease or condition.
No.
The device is a system of sterile, single-use components intended for the replacement of bone lost due to various conditions like oncology, trauma, or failed previous prostheses, which are all therapeutic interventions rather than diagnostic ones.
No
The device description clearly states it is comprised of "components" and is intended for "replacement of bone," indicating it is a physical implant, not software. The performance studies also focus on testing the device's compatibility within an MR environment, which is relevant for physical implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "replacement of bone due to radical bone loss." This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description reinforces that the device is comprised of components used for "radical bone loss of the femur and/or proximal tibia." This describes a physical implant for structural support and replacement within the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on laboratory tests.
The device is a surgical implant used for orthopedic reconstruction.
N/A
Intended Use / Indications for Use
Indications for the MRS Stems and Intercalary Stems (presented in K952970):
- This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.
- . The Intercalary System is intended for use in situations arising from femoral mid-shaft turnor resection, or for prosthetic knee fusion.
Indications for the Global Modular Replacement System (presented in K023087):
- Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.
Indications for the Global Modular Replacement System Press Fit Stems with HA Coating (presented in K022403, and K031217):
- Proximal femoral reconstruction secondary to:
- Trauma
- Failed previous prosthesis
- Tumor resection
Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581)
- Femoral replacement in Oncology cases where radical resection and replacement of bone is . required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement.
Indications for the Modular Replacement System Cemented Stems (cleared in K040749):
- Femoral and/or proximal tibial replacement due to:
- Trauma
- Failed previous prosthesis
- Tumor resection
Indications for the Modular Rotating Hinge Knee System (cleared in K002552)
The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where there is destruction of the joint surfaces, with or without significant bone deformity; the cruciate and/or collateral ligaments do not stabilize the knee joint; the ligaments are inadequate and/or the musculature is weak; and revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue.
Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.
Product codes (comma separated list FDA assigned to the subject device)
JDI, KRO, LZO, LPH
Device Description
The Global Modular Replacement System is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System or the Modular Rotating Hinge Knee System. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, proximal tibia, hip or knee joint
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)
Non-Clinical Testing:
The Global Modular Replacement System has been evaluated for use in a Magnetic Resonance Environment through non-clinical testing as outlined in the FDA guidance document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment -Guidance for Industry and FDA Staff'', dated May 20, 2021. This testing was conducted to characterize the compatibility of Stryker Orthopaedics GMRS passive implants in the MR environment. FDA guidance "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices -Guidance for Industry and FDA Staff", dated March 22, 2016, was also consulted for the heating evaluations performed. Testing was performed according to the standards listed below:
- Magnetically Induced Displacement Force Test Performed per ASTM F2052-15, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- Magnetically Induced Torque Test Performed per ASTM F2213-17, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- Image Artifact Test Performed per ASTM F2119-07 (2013), Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- Heating by RF Fields Test Performed per ASTM F2182-19e1, Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
Additional analyses have been performed to address heating in the tissue of interest as indicated in the May 2021 guidance document.
The labeling of the GMRS system 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. The labeling of the GMRS Press Fit Stems with Hydroxyapatite has also been revised to add an additional contraindication.
Clinical Testing:
Clinical testing was not required as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K952970, K022403, K031217, K032581, K040749, K002552
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
§ 888.3350 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 26, 2023
Howmedica Osteonics Corp., dba Stryker Orthopaedics Margaret Klippel Chief Regulatory Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K222056
Trade/Device Name: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, KRO, LZO, LPH Dated: January 13, 2023 Received: January 17, 2023
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.
1
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 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.
Limin Sun -S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
K222056
Device Name MRS Stems and Intercalary Stems
Indications for Use (Describe)
Indications for the MRS Stems and Intercalary Stems (presented in K952970):
· This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.
· The Intercalary System is intended for use in situations arising from in femoral mid-shaft tumor resection, or for prosthetic knee fusion.
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
3
510(k) Number (if known)
Device Name Global Modular Replacement System
Indications for Use (Describe) Indications for the Global Modular Replacement System (presented in K023087):
· Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 201 Subpart D) Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
_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)
Device Name GMRS Press Fit Stems with HA Coating
Indications for Use (Describe)
Indications for the Global Modular Replacement System Press Fit Stems with HA Coating (presented in K022403, and K031217):
Proximal femoral reconstruction secondary to:
- o Trauma
o Failed previous prosthesis
o Tumor resection
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)
Device Name
GMRS Anteverted Proximal Femoral Component
Indications for Use (Describe) Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581)
· Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral 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)
Device Name MRS System Cemented Stems
Indications for Use (Describe)
Indications for the Modular Replacement System Cemented Stems (cleared in K040749):
Femoral and/or proximal tibial replacement due to:
o Trauma
o Failed previous prosthesis
o Tumor resection
| Type of Use (Select one or both, as applicable) | Residential Use (Dwelling, RCF, Adult Foster Care, etc.) Other Use (Commercial, RCF, Adult Foster Care, etc.) | Residential Use (Dwelling, RCF, Adult Foster Care, etc.) | Other Use (Commercial, RCF, Adult Foster Care, etc.) |
|---|---|---|---|
| Residential Use (Dwelling, RCF, Adult Foster Care, etc.) | Other Use (Commercial, RCF, Adult Foster Care, etc.) |
| * 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 Modular Rotating Hinge Knee System
Indications for Use (Describe)
Indications for the Modular Rotating Hinge Knee System (cleared in K002552)
The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where there is destruction of the joint surfaces, with or without significant bone deformity; the cruciate and/or collateral ligaments do not stabilize the knee joint; the ligaments are inadequate and/or the musculature is weak; and revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue.
Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.
| 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) Summary
| Sponsor | Howmedica Osteonics Corp. dba Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Margaret Klippel
Chief Specialist, Regulatory Affairs
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
(201) 831-5559
Email: Margaret.klippel@stryker.com |
| Date Prepared: | January 4, 2023 |
| Proprietary Name: | Global Modular Replacement System |
| Common Name: | Hip Replacement, Rotating Hinge Knee Replacement |
| Regulatory Class: | Class II |
| Classification Panel: | 87, Orthopedic |
| Regulation: | 888.3350, 888.3510, 888.3353, 888.3358 |
Legally Marketed Devices to which Substantial Equivalence is Claimed:
Predicate Howmedica Osteonics (aka Stryker Orthopaedic) Global Modular Replacement System devices were cleared per the following primary 510(k) submission:
| Submission Number | Device Name | Product Codes |
|---|---|---|
| K023087 | Global Modular Replacement System | JDI, KRO |
Legally Marketed Reference Devices Used to Support Substantial Equivalence:
| Submission Number | Device Name | Product Code(s) |
|---|---|---|
| K952970 | Modular Replacement System | JDI, KRO |
| K022403 | GMRS Press Fit Stems with HA | LZO |
| K031217 | 11mm GMRS Press Fit Stems with HA | LZO |
| K032581 | GMRS Anteverted Proximal Femoral | |
| Component | LPH |
9
| Submission Number | Device Name | Product Code(s) |
|---|---|---|
| K040749 | Modular Replacement System Cemented | |
| Stems | KRO | |
| K002552 | Modular Rotating Hinge Knee | KRO |
Reason for 510(k) Submission:
The purpose of this submission is to modify the labeling of the Global Modular Replacement System components to add MR Conditional language. An additional contraindication is being added to the GMRS Press Fit Stems with Hydroxyapatite.
Device Description:
The Global Modular Replacement System is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System or the Modular Rotating Hinge Knee System. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis.
Indications for Use
The Stryker Global Modular Replacement System components are sterile, single-use devices intended for use in situations where there is a need for replacement of bone due to radical bone loss. This loss can be related to oncology, trauma or failed previous prosthesis.
Specific Indications for Use are listed below.
Indications for the MRS Stems and Intercalary Stems presented in K952970:
- This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.
- . The Intercalary System is intended for use in situations arising from femoral mid-shaft turnor resection, or for prosthetic knee fusion.
Indications for the Global Modular Replacement System presented in K023087:
- . Femoral and/or proximal tibial replacement and total femoral replacement in Oncology
10
cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.
Indications for the Global Modular Replacement System Press Fit Stems with HA Coating (presented in K022403, and K031217):
- Proximal femoral reconstruction secondary to: 0
- Trauma o
- Failed previous prosthesis о
- Tumor resection O
Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581)
-
Femoral replacement in Oncology cases where radical resection and replacement of bone is . required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement.
Indications for the Modular Replacement System Cemented Stems (cleared in K040749): -
Femoral and/or proximal tibial replacement due to: ●
- Trauma O
- Failed previous prosthesis O
- Tumor resection o
Indications for the Modular Rotating Hinge Knee System (cleared in K002552)
The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where there is destruction of the joint surfaces, with or without significant bone deformity; the cruciate and/or collateral ligaments do not stabilize the knee joint; the ligaments are inadequate and/or the musculature is weak; and revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue.
11
Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.
Summary of Technological Characteristics:
There have been no changes to the technological characteristics of the subject Global Modular Replacement System devices as a result of the labeling to add MR Conditional language. The subject GMRS components have the same design and are manufactured from the same materials as the corresponding proximal femoral bodies and distal stems of the predicate devices.
Non-Clinical Testing:
The Global Modular Replacement System has been evaluated for use in a Magnetic Resonance Environment through non-clinical testing as outlined in the FDA guidance document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment -Guidance for Industry and FDA Staff'', dated May 20, 2021. This testing was conducted to characterize the compatibility of Stryker Orthopaedics GMRS passive implants in the MR environment. FDA guidance "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices -Guidance for Industry and FDA Staff", dated March 22, 2016, was also consulted for the heating evaluations performed. Testing was performed according to the standards listed below:
- Magnetically Induced Displacement Force Test Performed per ASTM F2052-15, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- Magnetically Induced Torque Test Performed per ASTM F2213-17, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- Image Artifact Test Performed per ASTM F2119-07 (2013), Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- Heating by RF Fields Test Performed per ASTM F2182-19e1, Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
Additional analyses have been performed to address heating in the tissue of interest as indicated in the May 2021 guidance document.
12
The labeling of the GMRS system 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. The labeling of the GMRS Press Fit Stems with Hydroxyapatite has also been revised to add an additional contraindication.
Clinical Testing:
Clinical testing was not required as a basis for substantial equivalence.
Conclusion:
Based upon a comparison of the intended use, materials, summary of technological characteristics, and preclinical evaluation, the subject Global Modular Replacement System components are considered substantially equivalent to the predicate devices identified in this premarket notification.