The DYNASTY® Dual Mobility Inserts and Liners, when used with compatible acetabular shells and femoral heads, are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. In revision arthroplasties, all devices associated with the wear couple must be removed and replaced.

Indications for Use:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and;
revision procedures where other treatments or devices have failed;
dislocation risks;
treatment of non-union, femoral neck fractures of the proximal femur with head involvement which are unmanageable by other techniques

Dual Mobility Inserts and Liners are single use implants intended for uncemented arthroplasty.

Device Description

The Dual Mobility (DM) Inserts and Liners are designed for use with compatible DYNASTY® acetabular shells, MicroPort Orthopedics non-skirted femoral heads and PROFEMUR® femoral stems, to create a system with two articulating interfaces in the acetabular joint space of the hip.

The E-CLASS® DUAL MOBILITY INSERTS are manufactured from Vitamin E cross linked polyethylene conforming to ASTM F2695 and are available with an inner diameter of 28 mm and outer diameters from 38 mm to 56 mm in 2 mm increments. The E-Class® DM Inserts are compatible with and provide a primary articulating surface for all 28 mm, non-skirted femoral heads.

DM CoCr Liners are manufactured from cobalt chrome (CoCr) alloy conforming to ASTM F1537 (Type 1) and are available with inner diameters from 38 mm in 2 mm increments. The DM CoCr Liners are designed to mate with all DYNASTY® acetabular shells via a taper locking mechanism and provide the secondary articulating surface for the E-Class® DM Inserts.

AI/ML Overview

This document is a 510(k) Premarket Notification from MicroPort Orthopedics, Inc. to the FDA regarding their E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS. The document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.

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

Acceptance Criteria and Reported Device Performance

The document describes mechanical testing to demonstrate substantial equivalence, rather than a clinical study evaluating human-in-the-loop performance of an AI device. Therefore, the "acceptance criteria" discussed are for the mechanical properties of the orthopedic implants, not for an AI algorithm's diagnostic performance.

Tabla de criterios de aceptación y rendimiento informado del dispositivo:

Acceptance Criteria (based on standards)	Reported Device Performance
Adherence to EN ISO 21535 (2009) for Range of Motion (ROM) analysis	Data demonstrates substantial equivalence to the predicate device (ZIMMER BIOMET G7® DUAL MOBILITY SYSTEM (K150522)). Performance met acceptance criteria for ROM analysis.
Adherence to ASTM F2582-14, ASTM F1820-13, ISO 14242-1 (2014), ISO 14242-2 (2016) for Impingement Testing	Data demonstrates substantial equivalence to the predicate device. Performance met acceptance criteria for Impingement Testing.
Adherence to ASTM F1820-13 for Static Disassociation Testing (femoral head from insert)	Data demonstrates substantial equivalence to the predicate device. Performance met acceptance criteria for Static Disassociation Testing.
Adherence to ASTM F2003-02(2015), ISO 7206-6:2013 for High Angle Edge Loading (Fatigue Testing)	Data demonstrates substantial equivalence to the predicate device. Performance met acceptance criteria for High Angle Edge Loading (Fatigue Testing).
Adherence to ASTM F2003-02(2015), ISO 7206-6:2013 for Fretting and Corrosion Observational Assessment	Data demonstrates substantial equivalence to the predicate device. Performance met acceptance criteria for Fretting and Corrosion Observational Assessment.
Adherence to ISO 14242-1 (2014), ISO 14242-2 (2016), ISO 14242-3 (2009)/Amd 1 (2019) for Wear Testing and Engineering Analysis	Data demonstrates substantial equivalence to the predicate device. Performance met acceptance criteria for Wear Testing and Engineering Analysis.
Adherence to ASTM F1820-13 for Push-out, Lever-out, Torque-out (PO/LO/TO) Testing (liner from shell)	Data demonstrates substantial equivalence to the predicate device. Performance met acceptance criteria for PO/LO/TO Testing.
Adherence to ASTM F2052-6. ASTM F2119-7. ASTM F2182-11a for Magnetic Resonance Imaging (MRI) Safety Evaluation	Data demonstrates substantial equivalence to the predicate device. Performance met acceptance criteria for MRI Safety Evaluation.
Adherence to various ASTM and ISO standards (e.g., ASTM F2695-12, ISO 5834-2) for Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Rationale	Data demonstrates substantial equivalence to the predicate device. Performance met acceptance criteria for UHMWPE Characterization. The E-CLASS® DUAL MOBILITY INSERTS are specifically manufactured from Vitamin E cross-linked polyethylene conforming to ASTM F2695. The document concludes that the subject devices "do not introduce new or modified risks for safety and effectiveness compared to the predicate or other reference MicroPort Hip Systems and acetabular components which utilize comparable test methods and acceptance criteria."

Study Information (Mechanical Testing)

This document describes a premarket notification for an orthopedic implant, not an AI/software device. Therefore, the questions related to AI device performance evaluation (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone performance) are not directly applicable to the type of study described.

However, based on the provided text, we can infer some details about the mechanical testing study:

Sample size used for the test set and the data provenance:
- The sample size for each mechanical test is not explicitly stated (e.g., "n="). Instead, it mentions "MicroPort has evaluated the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS and data demonstrates substantial equivalence..." This implies multiple samples were tested for each specified mechanical test to comply with the relevant ASTM/ISO standards.
- Data Provenance: The testing was "performed for the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS" by MicroPort. The location is implied to be within MicroPort's testing facilities, likely in the US (Arlington, Tennessee, is mentioned as their address). It is inherently a prospective execution of validated test methods on newly manufactured devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of mechanical testing. "Ground truth" here refers to the precise measurements and evaluations against established engineering standards (ASTM, ISO). The "expertise" involved would be mechanical engineers and technicians conducting the tests and interpreting the results according to the specified standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Mechanical testing involves objective measurements rather than subjective expert consensus. Results are compared directly to numerical acceptance criteria defined by the standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI device or a human-in-the-loop study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The performance evaluation is inherently "standalone" in the sense that it's testing the physical properties of the device itself, not an algorithm's output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for mechanical testing is defined by the acceptance criteria specified in the referenced ASTM and ISO international standards. These standards provide the validated methodologies and performance thresholds for assessing the safety and efficacy of orthopedic implants.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning study requiring a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for mechanical testing.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The text reads "U.S. FOOD & DRUG ADMINISTRATION".

October 1, 2021

Microport Orthopedics, Inc. Matthew Paul Sr. Regulatory Affairs Project Manager 5677 Airline Road Arlington, Tennessee 38002

Re: K200011

Trade/Device Name: E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH. KWY. LZO. OOG Dated: September 2, 2021 Received: September 3, 2021

Dear Matthew Paul:

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

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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,

Limin Sun, 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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K200011

Device Name E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS

Indications for Use (Describe)

Indications for Use:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity; and;
revision procedures where other treatments or devices have failed;
dislocation risks;
treatment of non-union, femoral neck fractures of the proximal femur with head involvement which are unmanageable by other techniques

Dual Mobility Inserts and Liners are single use implants intended for uncemented 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.

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K200011 Page 1 of 3

	510(k) Summary
Submitted By:	MicroPort Orthopedics Inc.5677 Airline RoadArlington, TN 38002
	Telephone Number: (901) 290-5175
Date Prepared:	October 1, 2021
Contact Person:	Matthew Paul
	Sr. Regulatory Affairs Project Manager
	Telephone number: (901) 867-4350
	Email: matt.paul@ortho.microport.com
Name of Device:	E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUALMOBILITY LINERS
Common Name:	Dual Mobility Inserts and Dual Mobility Liners
Device Classification Name	21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis
And Reference:	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class:	Class II
Panel Code:	Orthopedics/87
Product Code:	LPH, KWY, LZO, OQG
Predicate Device:	ZIMMER BIOMET G7® DUAL MOBILITY SYSTEM (K150522)
Additional Predicate:	ZIMMER BIOMET G7® DUAL MOBILITY SYSTEM (K161190)
Reference Devices:	MEDACTA VERSAFITCUP® (K083116)
	ORTHOMET BIPOLAR HIP SYSTEM (K892398)
	PROCOTYL® PRIME® E-CLASS® XLPE LINERS (K171181)
	DYNASTY® COCR ACETABULAR LINERS (K061844)

Device Description:

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Intended Use Statement:

The DYNASTY® Dual Mobility Inserts and Liners, when used with compatible acetabular shells and femoral heads, are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in sketally mature patients. In revision arthroplasties, all devices associated with the wear couple must be removed and replaced.

Indications for Use

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, 1) protrusio acetabuli, and painful hip dysplasia:
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed;
1. dislocation risks;
treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur 6) with head involvement which are unmanageable by other techniques.

Dual Mobility Inserts and Liners are single use implants intended for uncemented arthroplasty.

Comparison of Technological Characteristics with the Predicate device:

Device comparison described in this premarket notification demonstrates that the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS are substantially equivalent to the identified predicate ZIMMER BIOMET G7® DUAL MOBILITY SYSTEM (K150522) cleared by the FDA for commercial distribution in the United States. The subject devices were shown to be substantially equivalent and have similar technological characteristics to their predicate and reference devices in areas including design, intended use, material composition, operational principles and function.

Discussion of the Non-clinical Testing/Performance Data:

Mechanical Testing:

MicroPort has evaluated the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS and data demonstrates substantial equivalence to the identified predicate ZIMMER BIOMET G7® DUAL MOBILITY SYSTEM (K150522).

The testing and engineering analyses performed for the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS included:

1. Range of Motion (ROM) Analysis utilizing EN ISO 21535 (2009)
1. Impingement Testing utilizing ASTM F2582-14, ASTM F1820-13, ISO 14242-1 (2014), ISO 14242-2 (2016),
1. Static Disassociation Testing of a femoral head from a dual mobility insert, utilizing ASTM F1820-13
1. High Angle Edge Loading (Fatigue Testing) utilizing ASTM F2003-02(2015), ISO 7206-6:2013
1. Fretting and Corrosion Observational Assessment utilizing ASTM F2003-02(2015), ISO 7206-6:2013
1. Wear Testing and Engineering Analysis utilizing ISO 14242-1 (2014), ISO 14242-2 (2016), ISO 14242-3 (2009)/Amd 1 (2019)
1. Push-out, Lever-out, Torque-out (PO/LO/TO) Testing of a dual mobility liner from a shell, utilizing ASTM F1820-13
1. Magnetic Resonance Imaging (MRI) Safety Evaluation utilizing ASTM F2052-6. ASTM F2119-7. ASTM F2182-11a
1. Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Rationale utilizing ASTM F2003-02(2015), ASTM F2102-13, ASTM F2183-02, ASTM F2214-02, ASTM F2565-13,

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ASTM F2625-10, ASTM F2695-12, ASTM F2381-10, ISO 5834-2 (2011), ISO 5834-3 (2005), ISO 5834-4 (2005), ISO 5834-5 (2005), ISO 11542-2 (1998), ISO 527-3 (1995)

The data demonstrate that the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS are substantially equivalent to the legally marketed predicate, ZIMMER BIOMET G7® DUAL MOBILITY SYSTEM (K150522). Having met all acceptance criteria for mechanical testing performed on worst case constructs, the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS do not introduce new or modified risks for safety and effectiveness compared to the predicate or other reference MicroPort Hip Systems and acetabular components which utilize comparable test methods and acceptance criteria.

Conclusion:

Based on the design features, the use of established well-known materials, feature comparisons, indications for use, principle of operations and results of the mechanical testing, the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS have shown to be substantially equivalent to the legally marketed predicate device cited in this premarket notification.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.