(146 days)
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.
The UNIKO PointCloud™ Knee Instruments are patient specific cutting guides 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" with numerical targets in a formal table separate from the performance data. However, the study aims to demonstrate that the device's accuracy is "at least comparable to those of the UNIKO PointCloud™ Knee Instruments (K193312)" (the secondary predicate device) and "substantially better than the literature reported results from convention total knee surgery."
Therefore, the implicit acceptance criteria are defined by the performance of the predicate device (K193312) and improvements over conventional surgery.
| Acceptance Criteria (Implicit) | Reported Device Performance (UNIKO PointCloud™ Knee Instruments) |
|---|---|
| Accuracy of Angular Measurements: | |
| - Varus/Valgus (Femur) comparable to Predicate K193312 | At least comparable to K193312. Substantially better than literature for conventional TKA. |
| - Flexion/Extension (Femur) comparable to Predicate K193312 | At least comparable to K193312. Substantially better than literature for conventional TKA. |
| - Internal/External Rotation (Femur) comparable to Predicate K193312 | At least comparable to K193312. Substantially better than literature for conventional TKA. |
| - Varus/Valgus (Tibia) comparable to Predicate K193312 | At least comparable to K193312. Substantially better than literature for conventional TKA. |
| - Flexion/Extension (Tibia) comparable to Predicate K193312 | At least comparable to K193312. Substantially better than literature for conventional TKA. |
| Accuracy of Resection Thickness | Comparable accuracy relative to the planned values. |
| Fit of Cutting Guides to Bone | Excellent. |
| Pinning Accuracy of Cutting Guides | Excellent (meaning matching bony landmarks consistently). |
| Consistency of Bone Resections | Consistent (demonstrated by maximum extension, flexion, and stability of operated knees, comparable to predicate). |
| Biocompatibility | Yes, according to ISO 10993. |
| Meets the Acceptance Criteria of the Planned Surgery | Yes. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 3 experienced orthopedic surgeons each performed 3 TKAs on 3 different cadaveric knees. This implies a total of 9 cadaveric knees in the test set.
- Data Provenance: The study was a cadaver study, which is a prospective study using human cadaveric specimens. The country of origin is not specified but is likely the US given the FDA submission.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: 3 experienced orthopedic surgeons.
- Qualifications of Experts: All 3 surgeons had prior experience using patient-specific instruments from different manufacturers. More specific qualifications (e.g., years of experience, fellowship training) are not provided.
4. Adjudication Method
The document does not explicitly describe an adjudication method for establishing ground truth or evaluating disagreements among the three surgeons. The text states: "All 3 surgeons had prior experience using patient-specific instruments from different manufacturers. Each surgeon performed 3 TKAs on 3 different knees." It then describes how measurements were taken and compared. There's no mention of a consensus process, independent review, or tie-breaking mechanism.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done to evaluate human readers with AI vs. without AI assistance.
The study involved surgeons using the UNIKO PointCloud™ Knee Instruments (which are derived from AI/software planning). Their performance was compared to:
- The UNIKO PointCloud™ Knee Instruments (K193312) – the secondary predicate device.
- Published literature on conventional Total Knee Arthroplasty (TKA), which would represent the "without AI assistance" or conventional approach.
While it makes a comparison, it's not structured as a typical MRMC study evaluating reader performance with and without an AI tool in a diagnostic or image interpretation context. Instead, it assesses the surgical accuracy achieved by surgeons using the AI-derived guides against historical data/predicate.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "cadaver study" directly evaluated the accuracy of the UNIKO PointCloud™ Knee Instruments (the algorithm-generated cutting guides) in terms of angular measurements and resection thickness when used by surgeons. This study assesses the performance of the device itself (the guides produced by the algorithm) after the pre-operative planning.
7. Type of Ground Truth Used
The ground truth used for performance evaluation appears to be:
- Pre-operative plan: The "accuracy of the resection thickness versus that specified in the pre-operative plan" was examined. This implies the pre-operative plan generated by the Vault® System Surgical Planning Software serves as a reference.
- Direct measurements: The study involved "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." The comparison of these direct measurements to planned values or predicate performance forms the basis of the ground truth for accuracy.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set used for the "Vault® System Surgical Planning Software" or for the UNIKO PointCloud™ Knee Instruments. It mentions that the Vault System was "previously cleared by FDA through K124051," and that the UNIKO PointCloud™ Knee Instruments use the output from this software.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set of the underlying Vault® System Surgical Planning Software or the UNIKO PointCloud™ Knee Instruments was established. It only states that the planning software "creates pre-op surgical plan based on MRI data" and that "Surgeon approves plan" before guides are manufactured.
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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 (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: 2024.06.2712:06:43 -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: | (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 prosthesisKnee 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
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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 | UNIKOPointCloud™ KneeInstruments | StrykerShapeMatchCutting Guides | UNIKOPointCloud™ KneeInstruments | |
|---|---|---|---|---|
| 510(k) number | K240327 | K122053 – PrimaryPredicate | K193312 –Secondary Predicate | ConclusionSubstantiallyEquivalent |
| Manufacturer | Unik Orthopedics Inc. | Stryker Corporation | Unik Orthopedics Inc. | |
| Product Code | MBH, JWH, OOG* | MBH, JWH, OOG* | MBH, OOG* | |
| Regulation | 21 CFR 888.356521 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 usedas a KneeArthroplastyImplantation System.Intended to be usedto assist in theimplantation of aspecific kneearthroplasty device ora set of specific kneearthroplasty devices. | Intended to be usedas a KneeArthroplastyImplantation System.Intended to be usedto assist in theimplantation of aspecific kneearthroplasty deviceor a set of specificknee arthroplastydevices. | Intended to be usedas a KneeArthroplastyImplantation System.Intended to be usedto assist in theimplantation of aspecific kneearthroplasty deviceor a set of specificknee arthroplastydevices. | SAME |
| Indications forUse | The UNIKOPointCloud™ KneeInstruments areintended to be usedas a surgicalinstrument to assistin the positioning ofTotal KneeReplacementcomponents intra-operatively and inguiding the markingof bone beforecutting provided thatanatomic landmarksnecessary foralignment andpositioning of theImplant areidentifiable on patientMRI scans.The UNIKOPointCloud™ KneeInstruments arecompatible with thefemoral and tibialcomponents of theDIO Surgical | The ShapeMatchCutting Guides areintended to be usedas patient-specificsurgicalinstrumentation toassist in thepositioning of totalknee arthroplastycomponentsintraoperatively andin guiding themarking of bonebefore cuttingprovided thatanatomic landmarksnecessary foralignment andpositioning of theimplant areidentifiable onpatient imagingscans.The ShapeMatchCutting Guides areintended for use withthe CR, PS, CScomponents of theTriathlon Knee | The UNIKOPointCloud™ KneeInstruments areintended to be usedas a surgicalinstrument to assistin the positioning ofTotal KneeReplacementcomponents intra-operatively and inguiding the markingof bone beforecutting provided thatanatomic landmarksnecessary foralignment andpositioning of theImplant areidentifiable on patientimaging scans.The UNIKOPointCloud™ KneeInstruments arecompatible with thefemoral and tibialcomponents of theDIO Surgical | SubstantiallyEquivalent(The onlydifferencesare in thecompatibleknee implantsystems) |
| Product | UNIKOPointCloud™ KneeInstruments | StrykerShapeMatchCutting Guides | UNIKOPointCloud™ KneeInstruments | Conclusion |
| 510(k) number | K240327 | K122053 – PrimaryPredicate | K193312 –Secondary Predicate | |
| Manufacturer | Unik Orthopedics Inc. | Stryker Corporation | Unik Orthopedics Inc. | |
| EMPWR 3D KneeSystem and theMaxx OrthopedicFreedom Total KneeSystem. TheIndications for Use ofthe DJO SurgicalEMPWR 3D KneeSystem and theMaxx OrthopedicFreedom Total KneeSystem remain thesame as thosecleared in themanufacturer'sclearance for theimplant system. | System. Theindications for use ofthe Triathlon KneeSystem when usedwith the ShapeMatchCutting Guides are:General Total KneeArthroplasty (TKA)Indications:-Painful, disablingjoint disease of theknee resulting from;degenerativearthritis, rheumatoidarthritis or post-traumatic arthritis.-Post-traumatic lossof knee jointconfiguration andfunction.-Moderate varus,valgus, or flexiondeformity in whichthe ligamentousstructures can bereturned to adequatefunction and stability.-Failedreconstructionprocedures which didnot involve theimplantation ofhardware on thecondylar surfaces.AdditionalIndications forPosteriorStabilized(PS) :-Ligamentousinstability requiringimplant bearingsurface geometrieswith increasedconstraint.-Absent or non-functioning posteriorcruciate ligament.-Severeanteroposteriorinstability of the kneejoint. | EMPWR 3D KneeSystem. TheIndications for Use ofthe DJO SurgicalEMPWR 3D KneeSystem remain thesame as thosecleared in themanufacturer'sclearance for theimplant system. | ||
| Product | UNIKOPointCloud™ KneeInstruments | StrykerShapeMatchCutting Guides | UNIKOPointCloud™ KneeInstruments | 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 | UNIKOPointCloud™ KneeInstruments | StrykerShapeMatchCutting Guides | UNIKOPointCloud™ KneeInstruments | |
| 510(k) number | K240327 | K122053 – Primary Predicate | K193312 – Secondary Predicate | |
| Manufacturer | Unik Orthopedics Inc. | Stryker Corporation | Unik Orthopedics Inc. | Conclusion |
| Meets theAcceptanceCriteria of thePlannedSurgery | Yes | N/A | Yes | SubstantiallyEquivalent |
| MeetsBiocompatibilityaccording toISO 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.
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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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Image /page/9/Picture/1 description: The image shows the logo for UNIK Orthopedics. The word "UNIK" is written in large, blue letters. Below the word "UNIK" is the word "ORTHOPEDICS" in smaller, black letters. The "O" in UNIK is gray.
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.
§ 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.