MyKnee PPS-Pin Positioners

K170106 · Medacta International S.A. · JWH · Oct 20, 2017 · Orthopedic

Device Facts

• Record ID: K170106
• Device Name: MyKnee PPS-Pin Positioners
• Applicant: Medacta International S.A.
• Product Code: JWH · Orthopedic
• Decision Date: Oct 20, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2

Intended 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.

Device Story

MyKnee® PPS-Pin Positioners are patient-specific, single-use femoral and tibial blocks used in total knee replacement surgery. Input consists of patient MRI data, processed using Mimics and Solidworks software to create 3D anatomical models. The device acts as a physical guide for surgeons to place pins for standard metal cutting instruments (distal/tibial and 4-in-1 femoral guides) based on a pre-operative plan. Used intraoperatively by orthopedic surgeons, the positioners facilitate accurate bone marking and component alignment. By matching the patient's specific anatomy, the device aims to improve the precision of knee replacement component positioning compared to traditional instrumentation, potentially enhancing surgical outcomes.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by non-clinical bench testing, including design comparison (dimensional/geometrical), breakage evaluation, manufacturing process evaluation, and functional/fitting evaluation. Sterilization validation included dimensional and functional impact studies and gamma sterilization criticality assessment.

Technological Characteristics

Patient-specific femoral and tibial positioning blocks manufactured from medical grade nylon via sintering. Dimensions vary by patient anatomy (femoral sizes 1-7, tibial sizes 1-6). Operates as a mechanical guide for surgical instrumentation. Compatible with GMK Total Knee System. Provided in sterile and non-sterile versions. Software-assisted design process using MRI data.

Indications for Use

Indicated for patients undergoing total knee replacement requiring anatomical pin positioning to assist in component placement and bone marking. Intended for use with the GMK Total Knee System. Single use only.

Regulatory Classification

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).

Predicate Devices

• MyKnee® Cutting Blocks (K093806)

Reference Devices

• MySpine Pedicle Screw Placement Guides-LP (K153273)
• GMK Total Knee System (K090988)
• GMK-Line Extension (K120790)
• GMK Sphere (K121416)
• GMK Sphere Extension (K140826)
• GMK Narrow (K122232)

Submission Summary (Full Text)

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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);

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# 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 [phone] or [phone] 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known)

K170106

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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# 3.0 510(k) Summary

### I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone [phone] Fax [phone]

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-<br>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

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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. ●

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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<br>(Subject Device) | MyKnee® Cutting Blocks<br>K093806<br>(Predicate Device) |
|-----------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Design/Types | Distal femoral and proximal<br>tibial pin positioning blocks. | Distal femoral and proximal<br>tibial cutting blocks. |
| Material | Medical Grade Nylon for<br>sintering | Medical Grade Nylon for<br>sintering |
| Sizes | Femoral blocks- Sizes 1-7<br>Tibial blocks- Sizes 1-6 | Femoral blocks- Sizes 1-7<br>Tibial blocks- Sizes 1-6 |
| Compatibility<br>with implant<br>system | GMK Total Knee System<br>GMK Primary Femur (size 7)<br>GMK Sphere<br>GMK-Primary Narrow | GMK Total Knee System |
| Device usage | Single Use | Single Use |
| Shelf Life | 6 months | 6 months |
| Biocompatibility | Short term <24 hours contact<br>(Equivalency determined) | Short term <24 hours contact<br>Tested to ISO 10993-1, -5, -10 |
| Sterilization | Non Sterile and Gamma | Non Sterile and Gamma |
| Packaging | Individual packaging | Individual packaging |
| Image Files<br>Applicable | MRI | CT, MRI |
| Alignment<br>Technique | Mechanical axis | Mechanical axis |

Technological comparison

# Discussion

As seen above, the differences between the subject and predicate devices are the subject devices do not have an integrated cut slot like the predicate devices. This technological difference does not raise new questions of safety or effectiveness. A comparison evaluation shows there are no new risks associated with the subject devices design.

Medacta International SA has not made any changes to the patient contacting material of the subject devices which is identical to the predicate devices. There have been no changes to subject devices' sterilization method, sterilization process or packaging materials which are identical to the predicate devices.

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### VII. Performance Data

Based on the risk analysis, a design comparison and cadaver workshops were conducted according to written protocols. The following studies were performed in support of a substantial equivalence determination:

Non-Clinical Studies

- o design comparison (dimensional/geometrical);
- breakage evaluation;
- o manufacturing process evaluation; and
- o functional and fitting evaluation.

Sterilization

- sterilization dimensional and functional impact study; and ●
- gamma sterilization criticality assessment. ●

Clinical Studies

- no clinical studies were conducted. ●
# VIII. Conclusion

The information provided above 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.