Modular Rotating Hinge Knee Systems and Compatible Components by Howmedica Osteonics Corp. dba Stryker Orthopaedics

· 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/or
· Revision is required of a failed prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue

Indication for Use for Duracon Components (Cobalt Chrome & Titanium Stems, and Tibial Wedges) and Stryker Stem Components:
Indications for use of total knee replacement prostheses include:

· noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis;
rheumatoid arthritis;
· correction of functional deformity;
· revision procedures where other treatments or devices have failed;
· post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and
· irreparable fracture of the knee.

Indications for US and Rest of World for Total Stabilizer Offset Adapter:
Indications for use of total knee replacement prostheses include:

Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis;

1. Rheumatoid arthritis;

Correction of functional deformity:
Revision procedures where other treatments or devices have failed;
Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and.
Irreparable fracture of the knee
When the Total Knee Replacement Prosthesis is used with the components of the Modular Rotating Hinge Knee System, the indication for the Modular Rotating Hinge Knee with Offset Adapters is as follows:
The Rotating Hinge Knee Systems are intended to be implanted with bone cement for the following condition(s):
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/or,
Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

GMRS Pediatric Tibial Bearing Component:
Replacement of the distal femur and/or proximal tibia 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. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement.

MRS Pediatric All Poly Tibial Component:
MRS Pediatric All Polyethylene Tibial Component is intended to be used in oncology patients where radical resection of the distal femur/proximal tibia is required. Additional indications include limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage includes surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications.

Device Description

The Modular Rotating Hinge (MRH) Knee System is a tri-compartmental knee system that consists of a stemmed femoral component and a stemmed tibial rotation component, connected by a set of bushings and an axle. A bumper locks this assembly. This assembly provides motion through the axle/bushing combinations in the flexion/extension plane. The articulation between the cylindrical bearing surfaces on the underside of the tibial rotating component and a tibial insert provide motion in the rotation plane. The tibial insert is assembled to a tibial stemmed tray which incorporates a longitudinal bore to accept a tibial sleeve.
The Modular Rotating Hinge Knee System is designed to provide varus/valgus stability throughout the range of motion, internal/external rotation about the tibial axis, constrained by the bearing surface radius on the tibial rotating component, and an extensive range of size, modularity and resection options. The implant system consists of a femoral component in five sizes, a tibial rotating component in five sizes, tibial crossover bearing components in various sizes, bumper inserts, tibial and femoral augmentation components and a tibial sleeve. The MRH Knee System is compatible with components of the Kinemax/Kinematic Knee System, Duracon Knee System, Howmedica Total Stabilizer Knee System, and the GMRS/MRS System.

AI/ML Overview

This document is a 510(k) premarket notification for several knee joint prostheses and related components. The submission's purpose is to modify the labeling of these devices to include "MR Conditional" information. Therefore, the "device" in question for this prompt is the MR Conditional labeling for the existing knee implant systems, not a new or modified implant design itself. The study discussed relates to the safety of these existing implants in an MRI environment.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Performance)	Reported Device Performance (Result and Standard)
Magnetically Induced Displacement Force	Device safely tested per ASTM F2052-15 ("Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"). Implicitly, met safety criteria for displacement force in an MR environment.
Magnetically Induced Torque	Device safely tested per ASTM F2213-17 ("Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment"). Implicitly, met safety criteria for magnetically induced torque in an MR environment.
MR Image Artifact	Device safely tested per ASTM F2119-07 (2013) ("Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants"). Implicitly, demonstrated acceptable levels of image artifact in an MR environment, not obscuring diagnostic information.
Heating by Radiofrequency (RF) Fields (including heating in the tissue of interest)	Device safely tested 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 performed to address heating in the tissue of interest as indicated in the May 2021 FDA guidance document. Implicitly, heating levels remained within safe limits for patients undergoing MRI scans.
Overall MR Conditional Labeling (to ensure patients with the device can be safely scanned)	The labeling of the Modular Rotating Hinge Knee Systems and components 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. This indicates that the test results support the provision of specific, safe MRI scanning parameters for these devices, meeting the criteria for MR Conditional labeling.
Substantial Equivalence to Predicate Devices (based on intended use, materials, technological characteristics, and preclinical evaluation)	"Based upon a comparison of the intended use, materials, summary of technological characteristics, and preclinical evaluation, the subject Modular Rotating Hinge Knee Systems and compatible components are considered substantially equivalent to their corresponding predicate devices identified in this premarket notification." This is the overarching regulatory acceptance criterion for the 510(k) submission, confirming that the changes (MR labeling) do not alter the substantial equivalence to existing, legally marketed devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in terms of number of physical devices tested or a number of patients or images. The testing described is non-clinical testing (phantom/bench testing) performed on the device components themselves to evaluate their interaction with MRI fields.

Sample Size: Not specified as typically understood for clinical studies (e.g., number of patients/images). This refers to physical samples of the device components or simulated constructs used in bench testing.
Data Provenance: This is non-clinical/bench testing data, likely generated in a laboratory setting by the manufacturer or a contract testing facility. "Country of origin" for non-clinical testing is not specified, but the applicant is based in Mahwah, New Jersey, USA. The testing is retrospective in the sense that it's performed on manufactured devices, but it's a prospective evaluation of their MRI safety characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For this type of non-clinical, MRI safety testing, "ground truth" is not established by human experts in the same way it would be for diagnostic image interpretation. The "ground truth" is determined by the physical measurements against established safety standards (e.g., ASTM standards for magnetic force, torque, heating, and artifact). The "experts" involved would be technicians and engineers skilled in conducting these specific non-clinical tests and interpreting their results against the predefined standard limits. Their qualifications would involve expertise in materials science, biomechanics, and MRI physics, along with knowledge of the relevant ASTM standards and FDA guidance documents. The document does not specify the number or specific qualifications of these individuals.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for clinical studies where human reviewers assess data. For non-clinical, objective measurements against established standards, the test results themselves, when within the specified limits of the standards, serve as the "adjudication."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence." This is a non-clinical evaluation of device safety with MRI, not a comparative study of diagnostic performance or human reader improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical knee implant component, not an algorithm or AI software. The testing evaluated the physical device's interaction with MRI machines.

7. Type of Ground Truth Used

The ground truth used in this submission is based on established engineering and medical device safety standards (specifically ASTM standards F2052-15, F2213-17, F2119-07, F2182-19e1) and FDA guidance documents (e.g., "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment..." and the May 2021 guidance document for heating in tissue). The "truth" is whether the measured physical properties (displacement, torque, artifact, heating) fall within the acceptable limits defined by these recognized standards and guidance.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The testing performed is non-clinical for MRI safety.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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April 21, 2023

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 & 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.

Howmedica Osteonics Corp. dba Stryker Orthopaedics Margaret Klippel Chief Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K223069

Trade/Device Name: Modular Rotating Hinge Knee System; KRH All Poly Tibial Component; Duracon Knee System Wedges, Stems, Stryker Stems; Total Stabilizer Offset Adapter; GMRS Pediatric Tibial Bearing Component; MRS Pediatric All Poly Tibial Component Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO. JWH, LGE Dated: March 22, 2023 Received: March 23, 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.

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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 medical devices and radiation-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.

Jesse Muir-S

Jesse Muir, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K223069

Device Name

Modular Rotating Hinge Knee System, KRH All Poly Tibial Component

Indications for Use (Describe)

The Modular Rotating Hinge Knee System is intended to be implanted with bone cement for the following conditions:

· 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/or

· Revision is required of a failed prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue

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) Number (if known)

K223069

Device Name

Duracon Knee System Wedges, Stems, Stryker Stems

Indications for Use (Describe)

Indication for Use for Duracon Components (Cobalt Chrome & Titanium Stems, and Tibial Wedges) and Stryker Stem Components:

Indications for use of total knee replacement prostheses include:

· noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis;
rheumatoid arthritis;
· correction of functional deformity;
· revision procedures where other treatments or devices have failed;
· post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and
· irreparable fracture of the knee.

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) Number (if known)

K223069

Device Name

Total Stabilizer Offset Adapter

Indications for Use (Describe)

Indications for US and Rest of World:

Indications for use of total knee replacement prostheses include:

Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis;

1. Rheumatoid arthritis;

Correction of functional deformity:
Revision procedures where other treatments or devices have failed;
Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and.
Irreparable fracture of the knee

When the Total Knee Replacement Prosthesis is used with the components of the Modular Rotating Hinge Knee System, the indication for the Modular Rotating Hinge Knee with Offset Adapters is as follows:

The Rotating Hinge Knee Systems are intended to be implanted with bone cement for the following condition(s):

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/or,
Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

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)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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510(k) Number (if known)

K223069

Device Name

GMRS Pediatric Tibial Bearing Component

Indications for Use (Describe)

Replacement of the distal femur and/or proximal tibia 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. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement.

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)

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510(k) Number (if known)

K223069

Device Name

MRS Pediatric All Poly Tibial Component

Indications for Use (Describe)

MRS Pediatric All Polyethylene Tibial Component is intended to be used in oncology patients where radical resection of the distal femur/proximal tibia is required. Additional indications include limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage includes surgical intervention for severe trauma, failed previous knee arthroplasties, 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)
----------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------

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510(k) Summary

Sponsor	Howmedica Osteonics Corp. dba Stryker Orthopaedics325 Corporate DriveMahwah, NJ 07430
Contact Person	Margaret Klippel,Chief Specialist, Regulatory AffairsHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430201-831-5559Email: Margaret.klippel@stryker.com
Date Prepared:	April 21, 2023
Proprietary Name:	Modular Rotating Hinge Knee SystemKRH All Poly Tibial ComponentDuracon Knee System Wedges, Stems, Stryker StemsTotal Stabilizer Offset AdapterGMRS Pediatric Tibial Bearing ComponentMRS Pediatric All Poly Tibial Component
Common Name:	Rotating Hinge Knee SystemArtificial Knee Components
Regulatory Class:	Class II
Classification Panel:	87, Orthopedic
Regulation:	888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis888.3560 – Knee joint patellofemorotibial polymer/metal polymer semi-constainedcemented prosthesis
Product Codes:	KRO, LGE, JWH

Legally Marketed Devices to which Substantial Equivalence is Claimed:

Predicate Modular Rotating Hinge Knee Systems were cleared per the following primary 510(k) submission:

Modular Rotating Hinge Knee System K994207 (product code KRO) .
The following are additional legally marketed reference devices used to support substantial equivalence:

Submission Number	Device Name	Product Code(s)
K001548	MRH Crossover Tibial Bearing Component	KRO

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Submission Number	Device Name	Product Code(s)
K001957	MRH Tibial Rotating Component	KRO
K002552	Modular Rotating Hinge Knee	KRO
K031480	GMRS Rediatric Tibial Bearing Component	KRO
K060360	MRH Knee with Offset Adapters	KRO
K792089	Kinematic Knee System	JWH
K972863	Duration Stabilized UHMWPE Knee Components	JWH
K915512	Duracon Total Knee Tibial Components	JWH
K973164	Howmedica Total Stabilizer Knee Components	JWH
K924482	Howmedica Total Knee Stem Extenders	JWH
K992346	Kinematic II Rotating Hinge Knee	LGE, KRO
K904208	Kinemax Superstabilizer Knee	JWH

Purpose of the Submission:

The purpose of this submission is to modify the labeling of the Modular Rotating Hinge Knee System and compatible components to add MR Conditional labeling.

Device Description

Modular Rotating Hinge Knee System

The Modular Rotating Hinge Knee System is designed to provide varus/valgus stability throughout the range of motion, internal/external rotation about the tibial axis, constrained by the bearing surface radius on the tibial rotating component, and an extensive range of size, modularity and resection options. The implant system consists of a femoral component in five sizes, a tibial rotating component in five sizes, tibial crossover bearing components in various sizes, bumper inserts, tibial and femoral augmentation components and a tibial sleeve. The MRH Knee System is compatible with components of the

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Kinemax/Kinematic Knee System, Duracon Knee System, Howmedica Total Stabilizer Knee System, and the GMRS/MRS System.

Intended Use

The Stryker Modular Rotating Hinge Knee System and the compatible components are all sterile, singleuse devices. Specific Indications for Use are listed below.

Modular Rotating Hinge Knee Systems and KRH All Poly Tibial Components

Rotating Hinge Knee Systems are intended to be implanted with bone cement for the following condition(s):

There is destruction of the joint surfaces, with or without significant bone deformity. 1)
1. The cruciate and/or collateral ligaments do not stabilize the knee joint.
1. The ligaments are inadequate and/or the musculature is weak and/or,
1. Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

Duracon Knee System Wedges, Stems, Stryker Stems

Indications for US and Rest of World:

Indications for use of total knee replacement prostheses include:

1. noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis;
1. rheumatoid arthritis;
1. correction of functional deformity;
1. revision procedures where other treatments or devices have failed;
post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction ર) or prior patellectomy; and
irreparable fracture of the knee. 6)

Total Stabilizer Offset Adapter

Indications for use of total knee replacement prostheses include:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis;
1. rheumatoid arthritis;
1. correction of functional deformity;
1. revision procedures where other treatments or devices have failed;
ર) post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and
1. irreparable fracture of the knee.

When the Total Knee Replacement is used with the components of the Modular Rotating Hinge Knee System, the indications for use for the Modular Rotating Hinge Knee with Offset Adapters is as follows: condition(s):

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1. There is destruction of the joint surfaces, with or without significant bone deformity.
1. The cruciate and/or collateral ligaments do not stabilize the knee joint.
The ligaments are inadequate and/or the musculature is weak and/or, 3)
1. Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

GMRS Pediatric Tibial Bearing Component

Replacement of the distal femur and/or proximal tibia 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. The smaller size component is intended to be used in patients with a smaller bone structure or in skeletally immature patients. This component is intended for use with bone cement.

MRS Pediatric All Poly Tibial Component

Summary of Technological Characteristics:

There have been no changes to the technological characteristics of the subject Modular Rotating Hinge Knee System and compatible comonents as a result of the revision to the labeling to add MR Conditional language. The subject Modular Rotating Hinge Knee Systems and compatible comonents have the same designs and are manufactured from the same materials as the corresponding predicate devices.

Non-Clinical Testing:

Non-clinical testing as outlined in the FDA guidance document titled "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices - Guidance for Industry and Food and Drug Administration Staff," dated March 22, 2016, was conducted for the heating evaluations performed. Testing was performed according to the standards listed below:

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· 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 Heathing 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 Modular Rotating Hinge Knee Systems and components have 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:

Based upon a comparison of the intended use, materials, summary of technological characteristics, and preclinical evaluation, the subject Modular Rotating Hinge Knee Systems and compatible components are considered substantially equivalent to their corresponding predicate devices identified in this premarket notification.

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.

Re: K223069

510(k) Number (if known)

Device Name

Indications for Use (Describe)

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Indications for Use (Describe)

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Indications for Use (Describe)

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Indications for Use (Describe)

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Indications for Use (Describe)

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510(k) Summary

Legally Marketed Devices to which Substantial Equivalence is Claimed:

Purpose of the Submission:

Device Description

Modular Rotating Hinge Knee System

Intended Use

Modular Rotating Hinge Knee Systems and KRH All Poly Tibial Components

Duracon Knee System Wedges, Stems, Stryker Stems

Total Stabilizer Offset Adapter

GMRS Pediatric Tibial Bearing Component

MRS Pediatric All Poly Tibial Component

Summary of Technological Characteristics:

Non-Clinical Testing:

Clinical Testing:

Conclusion:

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW