MicroPort knee instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Total Knee Systems in their cleared Indications for Use as provided below:

MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:
inflammatory degenerative joint disease including rheumatoid arthritis;
correction of functional deformity;
revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

Non-porous MicroPort total knee replacement implants are for cemented use only.

Porous coated MicroPort total knee replacement implants, including ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants, are for use without bone cement.

MicroPort's PROPHECY® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in quiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with MicroPort's ADVANCE® and EVOLUTION® Total Knee Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for single use only.

Device Description

The device modification consists of an alteration to the sterilization instructions for FDAcleared MicroPort Orthopedics' (MPO) non-sterile knee orthopedic joint replacement instruments. The subject instruments are part of MicroPort Orthopedics' 510(k)-cleared knee product lines and are required to facilitate total knee arthroplasty procedures. The modification will allow the option to sterilize the subject instruments using an FDA-cleared containment device. The subject devices will be placed in an FDA-cleared containment device, which will be double-wrapped in an FDA-cleared CSR wrap or similar type nonwoven, medical grade wrapping material, and then steam sterilized.

The modified sterilization process of the subject instruments was successfully challenged and validated through worst-case load configurations using an FDA-cleared containment device. The intended use and sterilization parameters, such as cycle, temperature, and exposure time, remain identical to the predicate devices.

AI/ML Overview

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance Study for MPO Knee Instruments Reprocessing Change (K213817)

This submission (K213817) focuses on a modification to the sterilization instructions for existing, FDA-cleared MicroPort Orthopedics' non-sterile knee instruments. The device itself (the instruments) remains unchanged in its design or intended use. The study specifically validates the modified sterilization process.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for a sterilization process change rather than a new diagnostic or AI-driven device, the acceptance criteria are related to the effectiveness of the sterilization and the integrity of the instruments after the new process.

Acceptance Criteria	Reported Device Performance
Sterilization Efficacy (per AAMI ST77:2013 and AAMI ST79:2017): Achieves sufficient device sterility when instruments are placed in an FDA-cleared containment device (single-level and double-level trays) and steam sterilized.	Met: "The modified sterilization process of the subject instruments was successfully challenged and validated through worst-case load configurations using an FDA-cleared containment device." "MicroPort non-sterile orthopedic joint replacement instruments are able to withstand the reported sterilization cycles and achieve sufficient device sterility."
Instrument Integrity after Sterilization: Instruments maintain their functionality and structural integrity after undergoing the modified sterilization process.	Met: Implied by the "Technological Characteristics Comparison" stating that instruments successfully withstand sterilization cycles, and the absence of any reported failures in nonclinical testing.
Vibration Resistance (per ISTA 2A): Packaging and instruments withstand vibration during transport after sterilization.	Met: "Vibration Test of MicroPort orthopedic joint replacement instruments using FDA-cleared containment device per ISTA 2A."

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

The document does not explicitly state a numerical "sample size" in terms of how many individual instruments were tested or how many sterilization cycles were run. However, the testing was conducted under "worst-case load configurations," implying a robust validation approach.

Sample Size: Not explicitly stated as a numerical count of individual instruments or cycles. Testing was performed under "worst-case load configurations" and for "MicroPort orthopedic joint replacement instruments."
Data Provenance: The studies were non-clinical validation tests performed by MicroPort Orthopedics Inc. There is no mention of country of origin for data or whether it was retrospective or prospective, as it pertains to laboratory validation of a manufacturing process change.

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

This section is not applicable to this submission. The device is a set of surgical instruments, and the study is a non-clinical validation of a sterilization process. There is no "ground truth" to be established by human experts in the way that would apply to diagnostic imaging or AI devices. The conformity to sterilization standards (AAMI ST77:2013 and AAMI ST79:2017) and vibration testing (ISTA 2A) serves as the "ground truth" for the performance of the modified process.

4. Adjudication Method for the Test Set

This section is not applicable. Since there are no human experts establishing a ground truth for a diagnostic outcome, there is no adjudication method. The test results are objective measurements against established engineering and sterilization standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. A MRMC comparative effectiveness study is designed for evaluating human performance, often with and without AI assistance, typically in diagnostic tasks. This submission is for surgical instruments and a sterilization process change, so such a study is not relevant or required.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This question typically applies to AI algorithms. The device being discussed is physical surgical instrumentation, and the study is evaluating a sterilization process, not an algorithm's performance.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established by adherence to recognized industry standards and validated testing protocols for sterilization and material integrity:

Sterility: Demonstrated by successful validation according to AAMI ST77:2013 and AAMI ST79:2017, likely involving biological indicator testing and sterility assurance level (SAL).
Physical Integrity/Durability: Demonstrated by successful vibration testing according to ISTA 2A.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of validating a sterilization process for physical surgical instruments. Training sets are relevant for machine learning algorithms.

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

This section is not applicable, as there is no training set for this type of submission.

Summary

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January 5, 2022

Image /page/0/Picture/1 description: The image shows 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

MicroPort Orthopedics Inc. Gillen Gonzales Regulatory Affairs Specialist I 5677 Airline Road Arlington, Tennessee 38002

Re: K213817

Trade/Device Name: MPO Knee Instruments: MPO PROPHECY Knee Instruments Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH, OOG Dated: December 6, 2021 Received: December 7, 2021

Dear Gillen Gonzales:

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

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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,

Ting Song, PhD 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

e
E
Se

Submission Number (if known)

K213817

Device Name

MPO Knee Instruments;

MPO PROPHECY Knee Instruments

Indications for Use (Describe)

MicroPort knee instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Total Knee Systems in their cleared Indications for Use as provided below:

MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:
inflammatory degenerative joint disease including rheumatoid arthritis;
correction of functional deformity;
revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

Non-porous MicroPort total knee replacement implants are for cemented use only.

Porous coated MicroPort total knee replacement implants, including ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants, are for use without 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a white circle inside, containing a red diamond shape. To the right of the icon is the text "MicroPort" in a bold, blue font, with the word "Orthopedics" underneath in a smaller, lighter blue font.

510(k) Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for MPO Knee Instruments Reprocessing Change.

Submitted by:	MicroPort Orthopedics Inc.5677 Airline Road, Arlington, TN 38002Phone: 866-872-0211Fax: 855-446-2247
Date:	December 6, 2021
Contact Person:	Gillen GonzalesRegulatory Affairs Specialist I
Proprietary Name:	MPO Knee Instruments; MPO PROPHECY Knee Instruments
Common Name:	Orthopedic Surgical Instruments
Classification Name andReference:	21 CFR888.3565 Knee joint Patellofemorotibialmetal/Polymer Porous-Coated Uncemented prosthesisClass II21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesisClass II
Subject Product Code andPanel Code:	Orthopedics/87/ MBH, JWH, OOG
Predicate Devices:	EVOLUTION® MP CS/CR Porous Femur (K140735)EVOLUTION® Adaptive CS and PS Inserts (K140735)EVOLUTION® MP Revision Femoral System (K142550)ADVANCE® Porous Coated Spiked Tibial Base (K143366)EVOLUTION® BIOFOAM® Tibial System (K152298)ADVANCE® BIOFOAM® Tibia (K152298)EVOLUTION® Revision Tibial System (K162026)EVOLUTION® Revision CCK System (K171389)EVOLUTION® Stemmed CS Femur (K182125)PROPHECY® ADVANCE® Navigation Guides (K093405)PROPHECY® EVOLUTION® Navigation Guides (K103598)

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Image /page/5/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners on the left side, inside of which is a red star-like shape with a white outline. To the right of the square is the text "MicroPort" in a larger, bold, blue font, and below that is the text "Orthopedics" in a smaller, blue font.

DEVICE INFORMATION

A. Device Description

B. Intended Use

MicroPort knee instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Knee Systems in their cleared Indications for Use as provided below:

MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
1. inflammatory degenerative joint disease including rheumatoid arthritis;
1. correction of functional deformity;
1. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

Non-porous MicroPort total knee replacement implants are for cemented use only.

Porous coated MicroPort total knee replacement implants, including ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants, are for use without bone cement.

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Image /page/6/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners on the left side, inside of which is a white circle with a red diamond shape in the center. To the right of the square is the text "MicroPort" in a bold, blue font, with the word "Orthopedics" underneath in a smaller, blue font.

cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with MicroPort's ADVANCE® and EVOLUTION® Total Knee Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for single use only.

C. Technological Characteristics Comparison

MicroPort subject non-sterile knee orthopedic joint replacement instruments were successfully validated and sterilized using an FDA-cleared containment device. MicroPort non-sterile orthopedic joint replacement instruments are able to withstand the reported sterilization cycles and achieve sufficient device sterility.

D. Nonclinical Testing

Provided below is a summary table of the non-clinical testing that were performed using the subject device. The result demonstrated that the subject device nonclinical test results met the acceptance criteria of the standards.

Steam Sterilization Validation of MicroPort orthopedic joint replacement instruments ● using FDA-cleared containment device (single-level tray) per AAMI ST77:2013
Steam Sterilization Validation of MicroPort orthopedic joint replacement instruments ● using FDA-cleared containment device (double-level tray) per AAMI ST79:2017
Vibration Test of MicroPort orthopedic joint replacement instruments using FDA-● cleared containment device per ISTA 2A.

E. Clinical and Animal Testing

No clinical or animal testing were required.

F. Conclusions

The sterilization of the subject devices is substantially equivalent to the predicate devices. The safety and effectiveness of the modified sterilization method of the subject devices is adequately supported by the substantial equivalence information, materials information, and design control summaries data provided within this Premarket Notification. Validation testing and analysis data adequately support the substantial equivalence of MPO Knee Instruments Reprocessing Change.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.