(146 days)
No
The description focuses on patient-specific cutting guides machined from polyoxymethylene using off-the-shelf software, with no mention of AI or ML in the device description, intended use, or performance studies. The "Not Found" entries for mentions of AI/ML and descriptions of training/test sets further support this.
No.
This device is described as a surgical instrument used to assist in the positioning of Total Knee Replacement components, not to provide therapy itself.
No
The device is described as a surgical instrument and patient-specific cutting guide designed to assist in the positioning of Total Knee Replacement components and guide bone marking. It does not provide a diagnosis or information about a patient's medical condition.
No
The device description explicitly states that the UNIKO PointCloud™ Knee Instruments are "patient specific cutting guides which are machined from polyoxymethylene material". This indicates a physical, hardware component, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The UNIKO PointCloud™ Knee Instruments are surgical instruments used during surgery (intraoperatively) to assist in positioning and guiding bone cuts for total knee replacement. They interact directly with the patient's bone, not with specimens taken from the body.
- Intended Use: The intended use clearly states the device is used "intraoperatively" to assist in surgical procedures.
- Device Description: The description confirms they are "patient specific cutting guides" used during surgery.
The device utilizes patient MRI scans for planning, but the device itself is a physical surgical tool used on the patient during the procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications 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 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.
Product codes
JWH, OOG, MBH
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI scans
Anatomical Site
Knee joint (femur, tibia)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical instrument for orthopedic surgeons during Total Knee Replacement.
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)
A cadaver study was conducted to test the accuracy of the UNIKO PointCloud™ Knee Instruments cutting quides relative to the pre-operative plan, the previously cleared predicate and published literature. A total of 3 experienced orthopedic surgeons participated in the study. All 3 surgeons had prior experience using patient-specific instruments from different manufacturers. Each surgeon performed 3 TKAs on 3 different knees. This testing included measuring of the following angular measurements: varus/valgus, flexion/extension and internal/external rotation of the femur and varus/valgus and flexion/extension of the tibia. In all cases the accuracy of the measured angles was at least comparable to those of the UNIKO PointCloud™ Knee Instruments (K193312). These measures were also compared to published papers by (Matziolis - JBJS 2007: 89(2):236-243 and Ensini - CORR April 2007: 457:156-62) comparing data from a randomized study of computer-assisted and convention total knee arthroscopy. For all of the measured parameters, the results from the UNIKO PointCloud™ Knee Instruments were substantially better than the literature reported results from convention total knee surgery and comparable to those reported for the UNIKO PointCloud™ Knee Instruments.
The cadaver study also examined the measured accuracy of the resection thickness versus that specified in the pre-operative plan and demonstrated a comparable accuracy relative to the planned values. Overall, the fit of the cutting quides to the cadaver bone was considered to be excellent. All surgeons rated the pinning accuracy of the cutting guides as excellent meaning that the cut guides matched the bony landmarks consistently. The surgeons also evaluated the maximum extension, flexion and stability of the operated knees which demonstrated that the bone resections were consistent, and the values obtained were comparable to those of the predicate device.
The cadaver study demonstrated that the overall performance of the UNIKO PointCloud™ Knee Instruments performed favorably compared to the pre-operative plan and was at least comparable to the performance of the secondary predicate and to the accuracy reported for conventional surgical instruments in the literature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| Peter G. | Digitally signed by Peter G. Allen -S |
|---|---|
| Allen -S | Date: 2024.06.27 |
| 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
2
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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3
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: | (408) 883-5842 |
| Contact Person: | Charlie Chi, Ph.D. |
| Phone: | (408) 887-5842 |
| Date Prepared: | 21 June 2024 |
Device Information:
| Classification: | ClassII |
|---|---|
| Trade Name: | UNIKOPointCloud™ KneeInstruments |
| Common name: | CuttingGuide |
| Classification name: | Knee joint patellofemorotibial polymer/metal/ |
| polymer semi-constrained cemented prosthesis | |
| Knee joint patellofemorotibial metal/polymer porous- | |
| 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
4
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
PointCloud™ Knee
Instruments | Stryker
ShapeMatch
Cutting Guides | UNIKO
PointCloud™ Knee
Instruments | |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| 510(k) number | K240327 | K122053 – Primary
Predicate | K193312 –
Secondary Predicate | Conclusion
Substantially
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
21 CFR 888.3560 | 21 CFR 888.3565**
21 CFR 888.3560** | 21 CFR 888.3565***
21 CFR 888.3560*** | SAME |
| Intended Use /
Indication | | | | |
| Intended Use | Intended to be used
as a Knee
Arthroplasty
Implantation System.
Intended to be used
to assist in the
implantation of a
specific knee
arthroplasty device or
a set of specific knee
arthroplasty devices. | Intended to be used
as a Knee
Arthroplasty
Implantation System.
Intended to be used
to assist in the
implantation of a
specific knee
arthroplasty device
or a set of specific
knee arthroplasty
devices. | Intended to be used
as a Knee
Arthroplasty
Implantation System.
Intended to be used
to assist in the
implantation of a
specific knee
arthroplasty device
or a set of specific
knee arthroplasty
devices. | SAME |
| Indications 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 intra-
operatively 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
DIO Surgical | The ShapeMatch
Cutting Guides are
intended to be used
as patient-specific
surgical
instrumentation to
assist in the
positioning of total
knee arthroplasty
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 imaging
scans.
The ShapeMatch
Cutting Guides are
intended for use with
the CR, PS, CS
components of the
Triathlon Knee | The UNIKO
PointCloud™ Knee
Instruments are
intended to be used
as a surgical
instrument to assist
in the positioning of
Total Knee
Replacement
components intra-
operatively 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
imaging scans.
The UNIKO
PointCloud™ Knee
Instruments are
compatible with the
femoral and tibial
components of the
DIO Surgical | Substantially
Equivalent
(The only
differences
are in the
compatible
knee implant
systems) |
| Product | UNIKO
PointCloud™ Knee
Instruments | Stryker
ShapeMatch
Cutting Guides | UNIKO
PointCloud™ Knee
Instruments | Conclusion |
| 510(k) number | K240327 | K122053 – Primary
Predicate | K193312 –
Secondary Predicate | |
| Manufacturer | Unik Orthopedics Inc. | Stryker Corporation | Unik Orthopedics Inc. | |
| | EMPWR 3D Knee
System and the
Maxx Orthopedic
Freedom Total Knee
System. The
Indications for Use of
the DJO Surgical
EMPWR 3D Knee
System and the
Maxx Orthopedic
Freedom Total Knee
System remain the
same as those
cleared in the
manufacturer's
clearance for the
implant system. | System. The
indications for use of
the Triathlon Knee
System when used
with the ShapeMatch
Cutting Guides are:
General Total Knee
Arthroplasty (TKA)
Indications:
-Painful, disabling
joint disease of the
knee resulting from;
degenerative
arthritis, rheumatoid
arthritis or post-
traumatic arthritis.
-Post-traumatic loss
of knee joint
configuration and
function.
-Moderate varus,
valgus, or flexion
deformity in which
the ligamentous
structures can be
returned to adequate
function and stability.
-Failed
reconstruction
procedures which did
not involve the
implantation of
hardware on the
condylar surfaces.
Additional
Indications for
Posterior
Stabilized(PS) :
-Ligamentous
instability requiring
implant bearing
surface geometries
with increased
constraint.
-Absent or non-
functioning posterior
cruciate ligament.
-Severe
anteroposterior
instability of the knee
joint. | EMPWR 3D Knee
System. The
Indications for Use of
the DJO Surgical
EMPWR 3D Knee
System remain the
same as those
cleared in the
manufacturer's
clearance for the
implant system. | |
| Product | UNIKO
PointCloud™ Knee
Instruments | Stryker
ShapeMatch
Cutting Guides | UNIKO
PointCloud™ Knee
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 | Yes | SAME |
| Surgeon approves plan | Yes | Yes | Yes | SAME |
| Patient specific cutting guides manufactured based on surgical plan | Yes | Yes | Yes | SAME |
| Guides for initial distal femoral and proximal tibial bone cuts | Yes | Yes | Yes | SAME |
| Implant manufacturer's implant specific guides used to complete implant specific cuts | Yes | Yes | Yes | SAME |
| Performance Testing | | | | |
| Accuracy compared to Literature | At Least Equivalent to the Published Literature | Unknown | At Least Equivalent to the Published Literature | Substantially Equivalent |
| Accuracy compared to Predicate K193312 | At Least Equivalent to Predicate | Unknown | N/A | Substantially Equivalent |
| Product | UNIKO
PointCloud™ Knee
Instruments | Stryker
ShapeMatch
Cutting Guides | UNIKO
PointCloud™ Knee
Instruments | |
| 510(k) number | K240327 | K122053 – Primary Predicate | K193312 – Secondary Predicate | |
| Manufacturer | Unik Orthopedics Inc. | Stryker Corporation | Unik Orthopedics Inc. | Conclusion |
| Meets the
Acceptance
Criteria of the
Planned
Surgery | Yes | N/A | Yes | Substantially
Equivalent |
| Meets
Biocompatibility
according to
ISO 10993 | Yes | Yes | Yes | SAME |
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Image /page/6/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 the word UNIKO is the phrase UNIK ORTHOPEDICS.
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Image /page/7/Picture/1 description: The image shows the logo for UNIKO Orthopedics. The word "UNIKO" is written in large, blue, sans-serif font. To the right of the word "UNIKO" is a gray circle. Below the word "UNIKO" is the phrase "UNIK ORTHOPEDICS" in a smaller, sans-serif font.
8
Image /page/8/Picture/1 description: The image shows the logo for UNIKO Orthopedics. The word "UNIKO" is written in large, bold letters, with the letters "UNI" in blue and the letter "O" in gray. Below the word "UNIKO" is the phrase "UNIK ORTHOPEDICS" in smaller, black letters.
Performance Testing
A cadaver study was conducted to test the accuracy of the UNIKO PointCloud™ Knee Instruments cutting quides relative to the pre-operative plan, the previously cleared predicate and published literature. A total of 3 experienced orthopedic surgeons participated in the study. All 3 surgeons had prior experience using patient-specific instruments from different manufacturers. Each surgeon performed 3 TKAs on 3 different knees. This testing included measuring of the following angular measurements: varus/valgus, flexion/extension and internal/external rotation of the femur and varus/valgus and flexion/extension of the tibia. In all cases the accuracy of the measured angles was at least comparable to those of the UNIKO PointCloud™ Knee Instruments (K193312). These measures were also compared to published papers by (Matziolis - JBJS 2007: 89(2):236-243 and Ensini - CORR April 2007: 457:156-62) comparing data from a randomized study of computer-assisted and convention total knee arthroscopy. For all of the measured parameters, the results from the UNIKO PointCloud™ Knee Instruments were substantially better than the literature reported results from convention total knee surgery and comparable to those reported for the UNIKO PointCloud™ Knee Instruments.
The cadaver study also examined the measured accuracy of the resection thickness versus that specified in the pre-operative plan and demonstrated a comparable accuracy relative to the planned values. Overall, the fit of the cutting quides to the cadaver bone was considered to be excellent. All surgeons rated the pinning accuracy of the cutting guides as excellent meaning that the cut guides matched the bony landmarks consistently. The surgeons also evaluated the maximum extension, flexion and stability of the operated knees which demonstrated that the bone resections were consistent, and the values obtained were comparable to those of the predicate device.
The cadaver study demonstrated that the overall performance of the UNIKO PointCloud™ Knee Instruments performed favorably compared to the pre-operative plan and was at least comparable to the performance of the secondary predicate and to the accuracy reported for conventional surgical instruments in the literature.
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Conclusion
In summary, the UNIKO PointCloud™ Knee Instruments is equivalent to the predicates, Stryker ShapeMatch Cutting Guides and the UNIKO PointCloud™ Knee Instruments cleared through K193312. It has the same intended use, and substantially equivalent Indications for Use, technological characteristics and operating principles, design, and materials to both predicates. The results of performance testing demonstrate that the UNIKO PointCloud™ Knee Instruments performed favorably compared to the preoperative plan and was at least equivalent to the secondary predicate and to the accuracy reported for conventional surqical instruments in the literature. Furthermore, it did not raise any new questions of safety or effectiveness. The data presented supports a determination of Substantial Equivalence.