(281 days)
No
The description focuses on patient-specific anatomical guides derived from MRI data using standard CAD/CAM software (Mimics, Solidworks). There is no mention of AI/ML algorithms for image analysis, planning, or guide design.
No
The device is described as an anatomical pin positioner to assist in positioning total knee replacement components and guiding bone before cutting, which are surgical aids, not devices that provide therapy directly.
No
The device is described as an anatomical pin positioner designed to assist in the positioning of total knee replacement components and guide bone cutting, based on patient-specific MRI data. Its function is to facilitate surgical procedures, not to diagnose medical conditions or diseases.
No
The device description explicitly states that the MyKnee® PPS-Pin Positioners are "single use femoral and tibial pin positioning patient-specific blocks" manufactured from "medical grade nylon for sintering." This indicates a physical hardware component, not a software-only device. While software is used in the design process (processing MRI data into 3D models), the final medical device is a physical object.
Based on the provided information, the MyKnee® PPS-Pin Positioners are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MyKnee® PPS-Pin Positioners Function: The MyKnee® PPS-Pin Positioners are physical, patient-specific surgical guides used intraoperatively to assist in the positioning of knee replacement components and guide bone cutting. They are based on anatomical imaging (MRI) but do not analyze biological specimens.
- Intended Use: The intended use clearly states they are for assisting in surgical procedures, not for analyzing biological samples.
Therefore, the MyKnee® PPS-Pin Positioners fall under the category of surgical instruments or guides, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
MyKnee® PPS-Pin Positioners are intended to be used as anatomical pin positioners specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding of bone before cutting. MyKnee® PPS-Pin Positioners are intended for use with the GMK Total Knee System and its cleared indications for use. MyKnee® PPS-Pin Positioners are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The MyKnee® PPS-Pin Positioners are single use femoral and tibial pin positioning patient-specific blocks. The MyKnee® PPS-Pin Positioners are designed and manufactured from patient MRI imaging data so the positioners match the patient's anatomy. The MyKnee® PPS-Pin Positioners are used with Medacta International SA's existing GMK Total Knee System. GMK Primary, GMK Sphere and GMK-Primary Narrow. The pin positioners are developed only for placement of the standard metal instruments (distal/tibial cut guide and 4-in-1 femoral cut guide) following the positions planned by the surgeon.
The MRI images are provided by the hospitals to Medacta International SA prepared according to a specific protocol for an individual patient. Medacta International SA uses these images in combination with Mimics (Materialise) and Solidworks (Dassault Systemes) to import DICOM images from a patient's MRI scans and these scans are then processed into accurate 3D models. The Solidworks validation plan and report were reviewed as part of the predicate 510(k) MyKnee® Cutting Blocks (K093806).
The MyKnee® PPS-Pin Positioners are manufactured from medical grade nylon for sintering which is identical to the predicate devices. MyKnee® PPS-Pin Positioners blocks are available in sizes 1-7 for the femur and sizes 1-6 for the tibia. The pin positioners will be provided in both non-sterile and sterile versions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
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:
- design comparison (dimensional/geometrical);
- breakage evaluation;
- manufacturing process evaluation; and
- functional and fitting evaluation.
Sterilization:
- sterilization dimensional and functional impact study; and
- gamma sterilization criticality assessment.
Clinical Studies:
- no clinical studies were conducted.
Key results: The information provided supports that the MyKnee® PPS-Pin Positioners are as safe and effective as the predicate devices. Although minor differences in design exist between the subject and predicate devices, the evaluation supports that the differences do not raise any new questions of safety or effectiveness. Therefore, it is concluded that the MyKnee® PPS-Pin Positioners are substantially equivalent to the predicate devices.
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.
K153273, K090988, K120790, K121416, K140826, K122232
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
October 20, 2017
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medacta International SA % Elizabeth Rose Manager, Regulatory Affairs Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
Re: K170106
Trade/Device Name: MyKnee® PPS-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: September 20, 2017 Received: September 21, 2017
Dear Ms. Rose:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Elizabeth Rose
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name MyKnee® PPS-Pin Positioners
Indications for Use (Describe)
MyKnee® PPS-Pin Positioners are intended to be used as anatomical pin positioners specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding of bone before cutting. MyKnee® PPS-Pin Positioners are intended for use with the GMK Total Knee System and its cleared indications for use. MyKnee® PPS-Pin Positioners 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) |
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3
3.0 510(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 Affairs Manager Date Prepared: January 10, 2017 Date Revised: September 20, 2017
| II. | Device |
|---|---|
| Device Proprietary Name: | MyKnee® PPS-Pin Positioners |
| Common or Usual Name: | Total Joint Replacement |
| Classification Name: | Knee joint patellofemorotibial polymer/metal//polymer semi- |
| constrained cemented prosthesis | |
| Primary Product Code: | JWH |
| Regulation Number: | 21 CFR 888.3560 |
| Device Classification | 2 |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary Predicate:
-
0 MyKnee® Cutting Blocks, K093806, Medacta International SA
Reference Devices -
MySpine Pedicle Screw Placement Guides-LP, K153273, Medacta International SA
-
GMK Total Knee System, K090988, Medacta International SA
-
GMK-Line Extension, K120790, Medacta International SA (also referred to as GMK-● Primary)
-
GMK Sphere, K121416, Medacta International SA
-
GMK Sphere Extension, K140826, Medacta International SA ●
-
GMK Narrow, K122232, Medacta International SA (also referred to as GMK-Primary o Narrow)
IV. Device Description
The purpose of this submission is to gain clearance for the MyKnee® PPS-Pin Positioners which is a line extension to the currently marketed MyKnee® Cutting Blocks (K093806). The integrated
4
cut slots have been removed to make the pin positioners suitable for use in Standard or MIS (muscle sparing approach) surgical techniques.
The MyKnee® PPS-Pin Positioners are single use femoral and tibial pin positioning patientspecific blocks. The MyKnee® PPS-Pin Positioners are designed and manufactured from patient MRI imaging data so the positioners match the patient's anatomy. The MyKnee® PPS-Pin Positioners are used with Medacta International SA's existing GMK Total Knee System. GMK Primary, GMK Sphere and GMK-Primary Narrow. The pin positioners are developed only for placement of the standard metal instruments (distal/tibial cut guide and 4-in-1 femoral cut guide) following the positions planned by the surgeon.
The MRI images are provided by the hospitals to Medacta International SA prepared according to a specific protocol for an individual patient. Medacta International SA uses these images in combination with Mimics (Materialise) and Solidworks (Dassault Systemes) to import DICOM images from a patient's MRI scans and these scans are then processed into accurate 3D models. The Solidworks validation plan and report were reviewed as part of the predicate 510(k) MyKnee® Cutting Blocks (K093806).
The MyKnee® PPS-Pin Positioners are manufactured from medical grade nylon for sintering which is identical to the predicate devices. MyKnee® PPS-Pin Positioners blocks are available in sizes 1-7 for the femur and sizes 1-6 for the tibia. The pin positioners will be provided in both non-sterile and sterile versions.
V. Indications for Use
MyKnee® PPS-Pin Positioners are intended to be used as anatomical pin positioners specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. MyKnee® PPS-Pin Positioners are intended for use with the GMK Total Knee System and its cleared indications for use. MyKnee® PPS-Pin Positioners are intended for single use only.
VI. Comparison of Technological Characteristics
The MyKnee® PPS-Pin Positioners and the predicate devices share the following characteristics:
- . indications for use;
- materials; ●
- packaging;
- sizes; and
- o applicable mechanical axis.
The MyKnee® PPS-Pin Positioners are technologically different from the predicate devices as follows:
- design, removal of cut slots;
- image file applicable, MRI only; and
- sterile and non-sterile. ●
5
Biocompatibility testing was conducted on the predicate devices for the same material and testing supports the biological safety of the MyKnee® PPS-Pin Positioners. Additional biocompatibility testing was deemed unnecessary because the materials and manufacturing process are identical to the predicate devices described below.
A comparison of the subject and predicate devices is provided in the table below.
| Parameter | MyKnee® PPS-Pin Positioners
(Subject Device) | MyKnee® Cutting Blocks
K093806
(Predicate Device) |
|-----------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Design/Types | Distal femoral and proximal
tibial pin positioning blocks. | Distal femoral and proximal
tibial cutting blocks. |
| Material | Medical Grade Nylon for
sintering | Medical Grade Nylon for
sintering |
| Sizes | Femoral blocks- Sizes 1-7
Tibial blocks- Sizes 1-6 | Femoral blocks- Sizes 1-7
Tibial blocks- Sizes 1-6 |
| Compatibility
with implant
system | GMK Total Knee System
GMK Primary Femur (size 7)
GMK Sphere
GMK-Primary Narrow | GMK Total Knee System |
| Device usage | Single Use | Single Use |
| Shelf Life | 6 months | 6 months |
| Biocompatibility | Short term