(29 days)
No
The 510(k) summary describes a modification to the sterilization instructions for existing knee orthopedic joint replacement instruments. The focus is on the sterilization process and validation, not on any AI/ML capabilities. While patient imaging scans are mentioned in relation to the PROPHECY® Pre-Operative Navigation Alignment Guides (a predicate device), the description of the current modification does not indicate the use of AI/ML for processing these scans or for any other function of the instruments. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device described is an accessory instrument used during knee arthroplasty procedures, and patient-specific surgical instrumentation (navigation guides). These are tools that assist in the implantation of prosthetic devices and guide surgical procedures, rather than directly treating a condition or restoring function themselves. The actual "therapeutic devices" in this context would be the Total Knee Systems (implants).
No
The device is an accessory for surgical implantation and patient-specific surgical instrumentation that assists in positioning and guiding marking before cutting, which are functions related to treatment and procedure assistance, not diagnosis. The "patient imaging scans" are used to identify landmarks, not to diagnose a condition.
No
The device description explicitly states the device modification is an alteration to the sterilization instructions for "non-sterile knee orthopedic joint replacement instruments," which are physical hardware components. While there is mention of "patient imaging scans" and "Pre-Operative Navigation Alignment Guides," the core device being modified and described is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are "accessory devices and are intended to be used to assist in the implantation of MicroPort Total Knee Systems". This describes a surgical instrument used during a procedure, not a device used to test samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the sterilization process of "non-sterile knee orthopedic joint replacement instruments". This further reinforces that these are surgical tools.
- No mention of in vitro testing: There is no indication that the device is used to analyze biological samples (blood, tissue, etc.) or perform any kind of diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
MBH, JWH, OOG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient imaging scans
Anatomical Site
knee
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Nonclinical Testing:
- 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.
The result demonstrated that the subject device nonclinical test results met the acceptance criteria of the standards.
No clinical or animal testing were required.
Key Metrics
Not Found
Predicate Device(s)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
Indications for Use
e
E
Se
Submission Number (if known)
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.
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.
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.
3
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4
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 38002
Phone: 866-872-0211
Fax: 855-446-2247 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 6, 2021 |
| Contact Person: | Gillen Gonzales
Regulatory Affairs Specialist I |
| Proprietary Name: | MPO Knee Instruments; MPO PROPHECY Knee Instruments |
| Common Name: | Orthopedic Surgical Instruments |
| Classification Name and
Reference: | 21 CFR888.3565 Knee joint Patellofemorotibial
metal/Polymer Porous-Coated Uncemented prosthesis
Class II
21 CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented prosthesis
Class II |
| Subject Product Code and
Panel 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) |
5
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
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.
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:
-
- 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 guiding the marking of bone before
6
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.