UNIKO PointCloud™ Knee Instruments

K240327 · Unik Orthopedics, Inc. · JWH · Jun 27, 2024 · Orthopedic

Device Facts

• Record ID: K240327
• Device Name: UNIKO PointCloud™ Knee Instruments
• Applicant: Unik Orthopedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jun 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2

Intended Use

The UNIKO PointCloud™ Knee Instruments are intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient MRI scans. The UNIKO PointCloud™ Knee Instruments are compatible with the femoral and tibial components of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System. The Indications for Use of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System remain the same as those cleared in the manufacturer's clearances for the implant system.

Device Story

Patient-specific cutting guides (jigs) for total knee arthroplasty (TKA); machined from polyoxymethylene. Input: patient MRI scans processed via Vault® System Surgical Planning Software (K124051) to create individualized surgical plan. Output: physical cutting guides used intraoperatively by orthopedic surgeons to guide initial distal femoral and proximal tibial bone cuts. Guides establish references for femoral orientation; surgeon completes procedure using standard implant-specific instrumentation. Benefits: improved alignment accuracy compared to conventional instrumentation; consistent bone resection based on pre-operative plan. Used in clinical/surgical settings.

Clinical Evidence

Cadaver study with 3 experienced orthopedic surgeons performing 3 TKAs each (9 total). Primary endpoints: angular measurements (varus/valgus, flexion/extension, internal/external rotation) and resection thickness accuracy compared to pre-operative plan, predicate (K193312), and literature (Matziolis 2007, Ensini 2007). Results: accuracy comparable to predicate and superior to conventional surgery literature; pinning accuracy rated excellent; bone resections consistent.

Technological Characteristics

Materials: polyoxymethylene. Design: patient-specific, single-use, non-sterile cutting guides. Connectivity: utilizes output from external surgical planning software (Vault® System). Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for patients undergoing total knee replacement requiring assistance in positioning components and marking bone, provided anatomic landmarks are identifiable on MRI. Compatible with DJO Surgical EMPWR 3D and Maxx Orthopedics Freedom Total Knee systems.

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

• Stryker ShapeMatch Cutting Guides (K122053)
• UNIKO PointCloud™ Knee Instruments (K193312)

Submission Summary (Full Text)

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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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 27, 2024

Unik Orthopedics, Inc. Charlie Chi Founder & CTO 701 Fortune Drive. Unit E San Jose, California 95131

Re: K240327

Trade/Device Name: UNIKO PointCloudTM Knee Instruments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Codes: JWH. OOG. MBH Dated: April 5, 2024 Received: April 8, 2024

Dear Charlie Chi:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

| Peter G. | Digitally signed by Peter G. Allen -S |
|----------|---------------------------------------|
| Allen -S | Date: 2024.06.27<br>12:06:43 -04'00' |

For: Lixin Liu, Ph.D. 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

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## Indications for Use

510(k) Number (if known) K240327

Device Name UNIKO PointCloud™ Knee Instruments

#### Indications for Use (Describe)

The UNIKO PointCloud™ Knee Instruments are intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient MRI scans.

The UNIKO PointCloud™ Knee Instruments are compatible with the femoral and tibial components of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System. The Indications for Use of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System remain the same as those cleared in the manufacturer's clearances for the implant system.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for UNIKO Orthopedics. The word "UNIKO" is written in large, blue, sans-serif font. Below the word "UNIKO" is the phrase "UNIK ORTHOPEDICS" in a smaller, black, sans-serif font. To the right of the word "UNIKO" is a large, gray circle.

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## Applicant Information:

| Owner Name: | Unik Orthopedics, Inc. |
|-----------------|----------------------------|
| Address: | 1701 Fortune Drive, Unit E |
| | San Jose, CA 95131 |
| Phone: | [phone] |
| Contact Person: | Charlie Chi, Ph.D. |
| Phone: | [phone] |
| Date Prepared: | 21 June 2024 |

## Device Information:

| Classification: | ClassII |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | UNIKOPointCloud™ KneeInstruments |
| Common name: | CuttingGuide |
| Classification name: | Knee joint patellofemorotibial polymer/metal/<br>polymer semi-constrained cemented prosthesis<br>Knee joint patellofemorotibial metal/polymer porous-<br>coated uncemented prosthesis |
| Regulation number: | 21 CFR 888.3560 and 21 CFR 888.3565 |
| Classification Code: | JWH, OOG, MBH |

## Predicate Device:

The subject of this submission, the UNIKO PointCloud™ Knee Instruments, is substantially equivalent to the Primary Predicate, Stryker ShapeMatch Cutting Guides cleared by FDA through 510(k) K122053, and the Secondary Predicate, UNIKO PointCloud™ Knee Instruments which were cleared by FDA through 510(k) K193312. The subject device has the same intended use, indications for use, design, material, operational principles, and performance as the secondary predicate device, UNIKO PointCloud™ Knee Instruments. Additionally, the subject device has substantially equivalent intended use, indications for use, design, materials, and operational principles to the Primary Predicate, Stryker ShapeMatch Cutting Guides.

## Device Description:

The purpose of this submission is to add an additional cleared knee implant system to the previously cleared UNIKO PointCloud™ Knee Instruments cleared through 510(k) K193312. The predicate device was cleared for compatibility with the DJO Surgical EMPWR 3D Knee System and this submission provides for additional compatibility with the Maxx Orthopedics Freedom Total Knee System

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Image /page/4/Picture/1 description: The image shows the logo for UNIKO UNIK ORTHOPEDICS. The word UNIKO is in blue, with the O being a gray circle. Underneath UNIKO is the text UNIK ORTHOPEDICS.

The UNIKO PointCloud™ Knee Instruments use the TKA surgical plan that is output from the Vault® System Surgical Planning Software which was previously cleared by FDA through K124051. The surgeon plans a primary total knee replacement surgery using the Vault System and the output data file from the individualized surgical plan is utilized by the UNIKO PointCloud™ Knee Instruments to create the necessary files for the production of patient specific cutting guides for the initial cuts to the distal femur and proximal tibia.

The UNIKO PointCloud™ Knee Instruments are patient specific cutting quides which are machined from polyoxymethylene material by the by means of customized off-the-shelf software. These guides (also called jigs) aid the surgeon in making the initial distal femoral and the initial proximal tibial bone cuts along with establishing the references for femoral orientations used during total knee arthroplasty surgery. The surgeon then continues the surgical procedure with the conventional knee instrumentation provided by the implant manufacturer for the implant and size specific cuts required for implantation of the femoral and tibial total knee implants.

The UNIKO PointCloud™ Knee Instruments are patient specific and are intended as single use instruments compatible with the TKA femoral and tibial components of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System. The Indications for Use of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System remain the same as those cleared in the manufacturer's clearance for those implant systems.

#### Intended Use / Indication for Use:

The UNIKO PointCloud™ Knee Instruments are intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient MRI scans.

The UNIKO PointCloud™ Knee Instruments are compatible with the femoral and tibial components of the DJO Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System. The Indications for Use of the DJO Surqical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System remain the same as those cleared in the manufacturer's clearances for the implant system.

## Substantial Equivalence:

Like the Primary Predicate, Stryker ShapeMatch Cutting Guides, and the Secondary Predicate, UNIKO PointCloud™ Knee Instruments, the subject UNIKO PointCloud™ Knee Instruments are intended to be used as a Knee Arthroplasty Implantation System. That is, a device accessory or set of device accessories that aids the surgeon in performing the implantation of the knee implant. Also, like both predicate devices, the UNIKO PointCloud™ Knee Instruments is indicated for use with femoral and tibial components of compatible FDA cleared total knee implant systems. See the table below for the specific implant systems for each of the predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for UNIKO Orthopedics. The word "UNIKO" is written in large, blue, sans-serif font. Below the word "UNIKO" is the phrase "UNIK ORTHOPEDICS" in a smaller, sans-serif font. To the right of the word "UNIKO" is a gray circle.

## Technological Characteristics/Performance Data:

Substantial equivalence in materials and technological characteristics of the UNIKO PointCloud™ Knee Instruments and the predicate device is outlined in the table below:

| Product | UNIKO<br>PointCloud™ Knee<br>Instruments | Stryker<br>ShapeMatch<br>Cutting Guides | UNIKO<br>PointCloud™ Knee<br>Instruments | |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| 510(k) number | K240327 | K122053 – Primary<br>Predicate | K193312 –<br>Secondary Predicate | Conclusion<br>Substantially<br>Equivalent |
| Manufacturer | Unik Orthopedics Inc. | Stryker Corporation | Unik Orthopedics Inc. | |
| Product Code | MBH, JWH, OOG* | MBH, JWH, OOG* | MBH, OOG* | |
| Regulation | 21 CFR 888.3565<br>21 CFR 888.3560 | 21 CFR 888.3565**<br>21 CFR 888.3560** | 21 CFR 888.3565***<br>21 CFR 888.3560*** | SAME |
| Intended Use /<br>Indication | | | | |
| Intended Use | Intended to be used<br>as a Knee<br>Arthroplasty<br>Implantation System.<br>Intended to be used<br>to assist in the<br>implantation of a<br>specific knee<br>arthroplasty device or<br>a set of specific knee<br>arthroplasty devices. | Intended to be used<br>as a Knee<br>Arthroplasty<br>Implantation System.<br>Intended to be used<br>to assist in the<br>implantation of a<br>specific knee<br>arthroplasty device<br>or a set of specific<br>knee arthroplasty<br>devices. | Intended to be used<br>as a Knee<br>Arthroplasty<br>Implantation System.<br>Intended to be used<br>to assist in the<br>implantation of a<br>specific knee<br>arthroplasty device<br>or a set of specific<br>knee arthroplasty<br>devices. | SAME |
| Indications for<br>Use | The UNIKO<br>PointCloud™ Knee<br>Instruments are<br>intended to be used<br>as a surgical<br>instrument to assist<br>in the positioning of<br>Total Knee<br>Replacement<br>components intra-<br>operatively and in<br>guiding the marking<br>of bone before<br>cutting provided that<br>anatomic landmarks<br>necessary for<br>alignment and<br>positioning of the<br>Implant are<br>identifiable on patient<br>MRI scans.<br><br>The UNIKO<br>PointCloud™ Knee<br>Instruments are<br>compatible with the<br>femoral and tibial<br>components of the<br>DIO Surgical | The ShapeMatch<br>Cutting Guides are<br>intended to be used<br>as patient-specific<br>surgical<br>instrumentation to<br>assist in the<br>positioning of total<br>knee arthroplasty<br>components<br>intraoperatively and<br>in guiding the<br>marking of bone<br>before cutting<br>provided that<br>anatomic landmarks<br>necessary for<br>alignment and<br>positioning of the<br>implant are<br>identifiable on<br>patient imaging<br>scans.<br><br>The ShapeMatch<br>Cutting Guides are<br>intended for use with<br>the CR, PS, CS<br>components of the<br>Triathlon Knee | The UNIKO<br>PointCloud™ Knee<br>Instruments are<br>intended to be used<br>as a surgical<br>instrument to assist<br>in the positioning of<br>Total Knee<br>Replacement<br>components intra-<br>operatively and in<br>guiding the marking<br>of bone before<br>cutting provided that<br>anatomic landmarks<br>necessary for<br>alignment and<br>positioning of the<br>Implant are<br>identifiable on patient<br>imaging scans.<br><br>The UNIKO<br>PointCloud™ Knee<br>Instruments are<br>compatible with the<br>femoral and tibial<br>components of the<br>DIO Surgical | Substantially<br>Equivalent<br>(The only<br>differences<br>are in the<br>compatible<br>knee implant<br>systems) |
| Product | UNIKO<br>PointCloud™ Knee<br>Instruments | Stryker<br>ShapeMatch<br>Cutting Guides | UNIKO<br>PointCloud™ Knee<br>Instruments | Conclusion |
| 510(k) number | K240327 | K122053 – Primary<br>Predicate | K193312 –<br>Secondary Predicate | |
| Manufacturer | Unik Orthopedics Inc. | Stryker Corporation | Unik Orthopedics Inc. | |
| | EMPWR 3D Knee<br>System and the<br>Maxx Orthopedic<br>Freedom Total Knee<br>System. The<br>Indications for Use of<br>the DJO Surgical<br>EMPWR 3D Knee<br>System and the<br>Maxx Orthopedic<br>Freedom Total Knee<br>System remain the<br>same as those<br>cleared in the<br>manufacturer's<br>clearance for the<br>implant system. | System. The<br>indications for use of<br>the Triathlon Knee<br>System when used<br>with the ShapeMatch<br>Cutting Guides are:<br><i>General Total Knee<br/>Arthroplasty (TKA)</i><br>Indications:<br>-Painful, disabling<br>joint disease of the<br>knee resulting from;<br>degenerative<br>arthritis, rheumatoid<br>arthritis or post-<br>traumatic arthritis.<br>-Post-traumatic loss<br>of knee joint<br>configuration and<br>function.<br>-Moderate varus,<br>valgus, or flexion<br>deformity in which<br>the ligamentous<br>structures can be<br>returned to adequate<br>function and stability.<br>-Failed<br>reconstruction<br>procedures which did<br>not involve the<br>implantation of<br>hardware on the<br>condylar surfaces.<br><i>Additional<br/>Indications for<br/>Posterior<br/>Stabilized(PS)</i> :<br>-Ligamentous<br>instability requiring<br>implant bearing<br>surface geometries<br>with increased<br>constraint.<br>-Absent or non-<br>functioning posterior<br>cruciate ligament.<br>-Severe<br>anteroposterior<br>instability of the knee<br>joint. | EMPWR 3D Knee<br>System. The<br>Indications for Use of<br>the DJO Surgical<br>EMPWR 3D Knee<br>System remain the<br>same as those<br>cleared in the<br>manufacturer's<br>clearance for the<br>implant system. | |
| Product | UNIKO<br>PointCloud™ Knee<br>Instruments | Stryker<br>ShapeMatch<br>Cutting Guides | UNIKO<br>PointCloud™ Knee<br>Instruments | Conclusion |
| 510(k) number | K240327 | K122053 – Primary Predicate | K193312 – Secondary Predicate | |
| Manufacturer | Unik Orthopedics Inc. | Stryker Corporation | Unik Orthopedics Inc. | |
| Materials | | | | |
| Femur Jig Guide | polyoxymethylene | polyoxymethylene | polyoxymethylene | SAME |
| Femur Cutslot | polyoxymethylene | polyoxymethylene | polyoxymethylene | SAME |
| Tibia Jig Guide | polyoxymethylene | polyoxymethylene | polyoxymethylene | SAME |
| Tibia Cutslot | polyoxymethylene | N/A – one piece | polyoxymethylene | SAME |
| Design | | | | |
| Two part jig and cutslot | Yes | No, one piece jig and cut slot | Yes | Substantially Equivalent |
| Cutting Jigs are single use | Yes | Yes | Yes | SAME |
| Cutting Slots are single use | Yes | Yes | Yes | SAME |
| Cutting Guides are provided non-sterile | Yes | Yes | Yes | SAME |
| Technological Characteristics | | | | |
| Software creates pre-op surgical plan based on MRI data | Yes | Yes…