(55 days)
No
The description focuses on patient-specific guides based on CT images and preoperative planning, with no mention of AI or ML algorithms for image analysis, planning, or guide design.
No
The device aids in surgical planning and guiding instrument placement during knee replacement surgery, but it does not directly treat or cure a disease or condition.
No
This device is described as an "anatomical pin positioner" and "patient-specific pin positioner blocks" used intraoperatively to assist in positioning total knee replacement components and guiding bone marking. Its function is to facilitate a surgical procedure, not to diagnose a condition or disease.
No
The device description explicitly states that the MyKnee R Pin Positioners are manufactured from medical grade nylon and are physical blocks, indicating they are hardware, not software-only.
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 MyKnee® R Pin Positioners are used intraoperatively to assist in positioning total knee replacement components and guiding bone marking during surgery. This is a surgical aid, not a diagnostic test performed on samples outside the body.
- Device Description: The description reinforces that these are patient-specific pin positioner blocks used to position pins for standard surgical instruments.
- Lack of Diagnostic Function: The device does not analyze biological samples (blood, tissue, etc.) to provide information about a patient's health status, disease, or condition. Its function is purely mechanical and related to surgical guidance.
- Input Imaging Modality: While it uses CT images for design, the device itself is a physical tool used during surgery, not a system that interprets images for diagnostic purposes.
IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The MyKnee® R Pin Positioners do not fit this definition.
N/A
Intended Use / Indications for Use
MyKnee® R Pin Positioners are intended for use as anatomical pin positioners specific for a single patient anatomy in case of revision total knee replacement. They are designed based on CT images of a patient's knee and the primary TKA implant in situ to assist in positioning the total knee replacement components intraoperatively and in guiding the marking of bone prior to cutting. MyKnee® R Pin Positioners are intended for single use only. Resections are performed through the standard or revision cutting guides. These are positioned on the holes drilled through the MyKnee® R Pin Positioner blocks after removal of the primary total knee implant components and according to the surgeon's preoperative planning. MyKnee® R Pin Positioners are intended for use with GMK® Primary, GMK® SpheriKA, GMK® Revision, GMK® Hinge and their cleared indications for use.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
MyKnee R Pin Positioners are a line extension to the currently marketed MyKnee Cutting Blocks (K093806) and MyKnee PPS-Pin Positioners (K170106).
The MyKnee R blocks are single use, patient-specific pin positioner blocks designed based on CT images of a patient's knee and the primary TKA implant in situ. They are intended to position the pins for placement of the standard instruments according to the surgeon's preoperative surgical planning.
The MyKnee R Pin Positioners are manufactured from medical grade nylon for sintering which is identical to the predicate devices.
They are available in left and right configuration with sizes 1-6 for the both the femurs and the tibia and, as the predicate devices, they can be provided in both non-sterile version.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
patient's knee
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies
- Software validation;
- Cadaver testing validating subject devices' intended use, functional characteristics and features.
Biocompatibility data and sterilization studies submitted in support of the predicate devices were leveraged.
Clinical Studies:
- No clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). 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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
May 4, 2022
Medacta International S.A. % Chris Lussier Senior Director, Ouality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K220705
Trade/Device Name: MyKnee R Pin Positioners Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 9, 2022 Received: March 10, 2022
Dear Chris Lussier:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
For Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name MyKnee R Pin Positioners
Indications for Use (Describe)
MyKnee® R Pin Positioners are intended for use as anatomical pin positioners specific for a single patient anatomy in case of revision total knee replacement. They are designed based on CT images of a patient's knee and the primary TKA implant in situ to assist in positioning the total knee replacement components intraoperatively and in guiding the marking of bone prior to cutting. MyKne® R Pin Positioners are intended for single use only. Resections are performed through the standard or revision cutting guides. These are positioned on the holes drilled through the MyKnee® R Pin Positioner blocks after removal of the primary total knee implant components and according to the surgeon's preoperative planning. MyKnee® R Pin Positioners are intended for use with GMK® Primary, GMK® SpheriKA, GMK® Revision, GMK® Hinge and their cleared indications for use.
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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3
510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Sr. Director, Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: March 9, 2022 Date Revised: May 3, 2022
II. Device
| Device Proprietary Name: | MyKnee R Pin Positioners |
|---|---|
| Common or Usual Name: | Total Joint Replacement |
| Classification Name: | Knee joint patellofemorotibial polymer/metal//polymer |
| semiconstrained cemented prosthesis | |
| Primary Product Code: | JWH |
| Regulation Number: | 21 CFR 888.3560 |
| Device Classification: | II |
III. Predicate Device
Substantial equivalence is claimed to the following primary predicate device:
-
MyKnee PPS-Pin Positioners, K170106, Medacta Interational SA A
In addition, the following reference device is cited within the submission: -
A My Knee Cutting Blocks, K093806, Medacta International SA
IV. Device Description
MyKnee R Pin Positioners are a line extension to the currently marketed MyKnee Cutting Blocks (K093806) and MyKnee PPS-Pin Positioners (K170106).
The MyKnee R blocks are single use, patient-specific pin positioner blocks designed based on CT images of a patient's knee and the primary TKA implant in situ.
4
K220705 page 2 of 3
They are intended to position the pins for placement of the standard instruments according to the surgeon's preoperative surgical planning.
The MyKnee R Pin Positioners are manufactured from medical grade nylon for sintering which is identical to the predicate devices.
They are available in left and right configuration with sizes 1-6 for the both the femurs and the tibia and, as the predicate devices, they can be provided in both non-sterile version.
V. Indications for Use
MyKnee® R Pin Positioners are intended for use as anatomical pin positioners specific for a single patient anatomy in case of revision total knee replacement. They are designed based on CT images of a patient's knee and the primary TKA implant in situ to assist in positioning the total knee replacement components intraoperatively and in guiding the marking of bone prior to cutting. MyKnee® R Pin Positioners are intended for single use only. Resections are performed through the standard or revision cutting guides. These are positioned on the pins placed in the holes drilled through the MyKnee® R Pin Positioner blocks after removal of the primary total knee implant components and according to the surgeon's preoperative planning. MyKnee® R Pin Positioners are intended for use with GMK® Primary, GMK® Sphere, GMK® SpheriKA, GMK® Revision, GMK® Hinge and their cleared indications for use.
VI. Comparison of Technological Characteristics
The subject MyKnee R Pin Positioners and the predicate MyKnee PPS Pin Positioners (K170106) are substantially equivalent with regards to the following characteristics:
- guide design; ●
- checking features; ●
- manufacturing process; ●
- material;
- biocompatibility;
- device usage;
- sterility;
- shelf life; and
- packaging.
The MyKnee R Pin Positioners differs from the predicate device, MyKnee PPS Pin Positioners (K170106), with regards to the following characteristics:
- anchoring points; .
- sizes range; ●
- instruments compatibility; and ●
- applicable image file. ●
Discussion
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K220705 page 3 of 3
The slight differences between the subject and predicate devices do not raise new questions of safety and effectiveness. Medacta International SA has not made any changes to the manufacturing process, material, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices with respect to the predicate devices.
The comparison of technological characteristics and performance data provided within this submission, supports the substantial equivalence of the subject devices with respect to the predicate devices.
VII. Performance Data
Based on the risk analysis, testing activities were conducted to written protocols. The following validation and tests are provided in support of the substantial equivalence determination:
Non-Clinical Studies
- · Software validation;
- · Cadaver testing validating subject devices' intended use, functional characteristics and features.
Biocompatibility data and sterilization studies submitted in support of the predicate devices were leveraged.
Clinical Studies:
- No clinical studies were conducted. ●
VIII. Conclusion
The information provided above supports that the MyKnee R Pin Positioner are substantially equivalent to the predicate devices.