(259 days)
Not Found
No
The summary describes a mechanical knee implant system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are bench tests evaluating mechanical properties.
Yes
Explanation: The device is indicated for "reduction or relief of pain and/or improved knee function" in patients with severe knee conditions, which are therapeutic benefits.
No
Explanation: The device described is a Total Knee System, consisting of prosthetic components designed for surgical implantation to replace damaged knee joints. Its intended use is for the reduction or relief of pain and improved knee function in patients with severe knee conditions, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly outlines physical components made of materials like cobalt-chromium-molybdenum alloy, ultra high molecular weight polyethylene, and titanium alloy, which are implanted in the body. This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for knee arthroplasty to treat various knee conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a total knee replacement system (femoral component, tibial insert, patellar component, tibial base plate). These are physical implants designed to replace damaged joint structures.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status through in vitro analysis.
- Performance Studies: The performance studies described are bench tests evaluating the mechanical properties and performance of the implant components, not diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis,collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device system is designed for cement use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Prolixus™ Cruciate Retaining (CR) Total Knee System consists of three primary components: Cruciate Retaining (CR) Femoral Component, Cruciate Retaining (CR) Tibial Insert, Patellar component and Tibial base plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Test by EndoLab Mechanical Engineering GmbH
- 1.Fatigue test (Tibial base plate)
- 2.Knee constraint test
- 3.Knee Tibia and inserter component interlock strength test
- 4.Knee Femoral and Tibial insert contact area/pressure distribution test
- 5.Knee Femoral and Patella contact area/pressure distribution
- 6.Knee geometry and surfaces
- 7.Range of motion CAD analysis
B. Greenpia Technology, South Korea -
- Bacterial endotoxins test (BET), also known as the Lims Amebocyte Lysate (LAL) test)
C. Summary & Conclusions from Testings
- 1. Fatigue test (Tibial base plate)
- Five tibial trays tested herein at a maximum load of 900 N (200 lbs) passed 10 million load cycles without failure and therefore meet the suggested minimum fatigue strength by the ISO 21536. This results in a max. run- out bending moment of 22.5 Nm.
- 2. Knee constraint test
- Anterior-posterior constraint test
- The knee implant tested by the constraint test was found to withstand at 0° flexion a mean anterior load of -348 N (StdDev 9) and a mean posterior load of 149 N (StdDev4).
- The knee implant tested by the constraint test was found to withstand at 15° flexion a mean anterior load of -348 N (StdDev12) and a mean posterior load of 147 N (StdDev2).
- The knee implant tested by the constraint test was found to withstand at 90° flexion a mean anterior load of -349 N (StdDev3) and a mean posterior load of 154 N (StdDev4).
- The knee implant tested by the constraint test was found to withstand at 135° flexion a mean anterior load of -331 N (StdDev5) and a mean posterior load of 152 N (StdDev4).
- Medial lateral constraint test
- The knee implant tested by the constraint test was found to withstand at 0° flexion a mean lateral load of -396 N (StdDev3) and a mean medial load of 387 N (StdDev6).
- The knee implant tested by the constraint test was found to withstand at 15° flexion a mean lateral load of -385 N (StdDev7) and a mean medial load of 383 N (StdDev3).
- The knee implant tested by the constraint test was found to withstand at 90° flexion a mean lateral load of -415 N (StdDev3) and a mean medial load of 365 N (StdDev3).
- The knee implant tested by the constraint test was found to withstand at 135° flexion a mean lateral load of -370 N (StdDev21) and a mean medial load of 413 N (StdDev5).
- Internal-external rotation constraint test
- The knee implant tested by the constraint test was found to withstand at 0° flexion a mean external torque of -5.7 Nm (StdDev 0.4) and a mean internal torque of 5.8 Nm (StdDev 0.2).
- The knee implant tested by the constraint test was found to withstand at 15° flexion a mean external torque of -6.2 Nm (StdDev 0.3) and a mean internal torque of 5.8 Nm (StdDev 0.1).
- The knee implant tested by the constraint test was found to withstand at 90° flexion a mean external torque of -5.4 Nm (StdDev 0.1) and a mean internal torque of 6.3 Nm (StdDev 0.1).
- The knee implant tested by the constraint test was found to withstand at 135° flexion a mean external torque of -5.1 Nm (StdDev 0.4) and a mean internal torque of 5.7Nm (StdDev 0.1).
- Anterior-posterior constraint test
- 3. Knee Tibia and inserter component interlock strength test
- i. Disassembly Test by Anterior/Posterior Loading
- A total of six specimens were tested for tibial insert and tibial baseplate assembly in anteriorposterior loading direction. In this loading direction the established mean assembly load was found to be 138 N (StdDev 22). An additional orthogonal load was found required for complete assembly.
- A total of six specimens were tested for tibial insert and tibial baseplate disassembly in posterioranterior loading direction. In this loading direction the established mean disassembly load was found to be 1,459 N (StdDev 31). Plastic deformation of the snap-in locking mechanism was found as failure mode.
- ii. Disassembly Test by Medial/Lateral Loading
- One tibial insert and tibial baseplate assembly loaded in medial-lateral load direction was found to withstand loads > 754 N. At this load the point of load application was plastically deformed and test was stopped. No failure at the interconnection mechanism between the tibial insert and the tibial baseplate was found.
- One tibial insert and tibial baseplate assembly loaded in lateral-medial load direction was found to withstand loads > 720 N. At this load the point of load application was plastically deformed and test was stopped. No failure at the interconnection mechanism between the tibial insert and the tibial baseplate was found.
- iii. Disassembly Test by Pull-off Loading
- Tibial insert and tibial baseplate assemblies loaded in tensile mode was found to withstand a mean ultimate load of 2,015 N (StdDev 187) without the ability of tibia tilt.
- iv. Assembly Test in anteriorposterior direction
- A total of five specimens were tested for tibial insert and tibial baseplate assembly in anteroposterior loading direction with a tibial baseplate inclination of 70°(30° in top). In this loading direction a mean assembly load of 132 N (StdDev. 24) was determined at a displacement of 4.5 mm.
- v. Disassembly Test in anteriorposterior direction and lateral direction
- A total of five specimens were tested for tibial insert and tibial baseplate disassembly in anterior to posterior loading direction. In this loading direction a mean ultimate disassembly load of 804 N (StdDev. 70) was determined.
- i. Disassembly Test by Anterior/Posterior Loading
- 4. Knee Femoral and Tibial insert contact area/pressure distribution test
- The area of the contact stresses above 20 MPa found corresponds to typical findings. A direct comparison to the EndoLab database (n=19 test series) can be found. Please note that the data comprises different designs and implant sizes. It can be stated that the contact stresses and total contact areas of implant tested herein are within the common range of the predicate devices.
- 5. Knee Femoral and patella contact area/pressure distribution
- The aim of the test performed was to evaluate the pressure distribution and total contact area of the patella-femoral components under different flexion angles and loads. The smallest total contact area of the patella-femoral joint was 20.44 mm² (SD 0.29 mm2) at 15° flexion and the largest total contact area was 86.87 mm² (SD 0.92 mm²) at 135° flexion. The smallest contact area above 20 MPa was 11.61 mm² (SD 0.50 mm2) at 15° flexion and the highest contact area above 20 MPa was 66.07 mm² (SD 1.35 mm²) at 135° flexion.
- 6. Knee geometry and surfaces
- Femoral component-
- In accordance to ISO 7207-2 the articulating surface roughness has been described by the parameters Ra, Rz and Rt for five femoral components. Related to the demands of ISO 7207-1 the geometric dimensions were determined for the same five femoral components
- Surface finish:
- A total mean Ra value of 0.013 µm (Std. Dev. 0.001 µm) was measured.
- A total mean Rz value of 0.194 um (Std.Dev. 0.279 um) was measured.
- A total mean Rt value of 0.127 µm (Std.Dev. 0.003 µm) was measured. Referenced to the surface finish requirements according to ISO 7207-2 no femoral component exceeded a roughness value Ra grated than 0.1 µm.
- Tibia base component-
- The purpose of this analysis was to determine the geometric dimensions of five tibial trays according to ISO 7207-1 and to determine the surface roughness at the femoral surface of the tibial trays.
- Surface finish:
- A total mean Ra value of 0.62 um (Std. Dev. 0.078 um) was measured.
- A total mean Rz value of 3.37 um (Std.Dev. 0.410 um) was measured.
- A total mean Rt value of 5.05 µm (Std.Dev. 0.954 µm) was measured.
- Tibia insert component-
- The purpose of this analysis was to determine the minimum thickness of five unconstrained bi compartmental (fixed bearing) tibial inserts and to determine the surface roughness at the load bearing side of the tibial inserts.
- Surface finish:
- An overall mean Ra value of 0.212 um (Std. Dev. 0.079 um) was measured.
- An overall mean Rz value of 1.084 um (Std. Dev. 0.391 um) was measured.
- An overall mean Rt value of 1.776 um (Std. Dev. 0.598 um) was measured.
- Referenced to the surface finish requirements according to ISO 7207-2 , no insert exceeded a roughness value Ra greater than 2.0 µm. The surface roughness values determined for each insert at the different locations are shown
- Minimum thickness:
- A total mean lateral thickness of 6.77 mm (Std. Dev. 0.05 mm) and a total mean medial thickness of 6.77 (Std. Dev. 0.05 mm) have been determined. ISO 21536: 2007 (Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants) requires a minimum thickness in the load bearing area of 6 mm for components having a tibial tray. None of the inserts analyzed showed a minimum thickness smaller than 6 mm.
- Patella component-
- In accordance to ISO 7207-2 the interested articulating surface roughness has been determined by the parameters Ra, Rz and Rt for six patella components. Related to the demands of ISO 7207-1 the minimum thicknesses of have been determined for the same six patella components listed above.
- Surface finish:
- An overall mean Ra value of 0.79 µm (Std. Dev. 0.20 µm), an overall mean Rz value of 3.20 µm (Std.Dev. 0.65 µm) and an overall mean Rt value of 4.18 µm (Std. Dev. 0.98 um) were determined. Referenced to the surface finish requirements according to ISO 7207-2 (see section 5.1) no patella component exceeded a roughness value Ra greater than 2.0 um. The surface roughness values determined for each patella component at the different locations are shown.
- Minimum thickness and width dimensions:
- An overall mean thickness of 8.01 mm (Std. Dev. 0.05 mm) and an overall mean width of 25.98 (Std.Dev. 0.02 mm) have been determined.
- Femoral component-
- 7. Range of motion CAD analysis
- A CAD analysis of the TKR Otis Size 1 system has been performed using IGES files. A total of four different rotations/translations have been investigated: Flexion/extension, rotation, medial-lateral and anterior posterior translation. In addition, the medial as well as the lateral contact point have been investigated for seven different flexion angles. All motions observed correspond to typical findings as expected for fixed type bearings. The sliding/rolling analysis supports the common theory of mixed sliding/rolling articulations for this type of bearing. Varus/valgus rotation and proximal/distal translation are not constrained by this type of implant and have not been simulated. Due to the low degree of constraint, different types of articulating motions are expected in-vivo depending on the soft tissue balance, the muscular status as well as the daily living activities of the patient. The analysis of the kinematics presented herein therefore should be regarded as average positioning within an array of possible motions.
- 8. Pyrogen and Endotoxins Testing : Bacterial endotoxins test (BET), also known as the Limulus amebocyte lysate (LAL) test)
- As a result of endotoxin test validation for thThe PROLIXUS™ Cruciate Retaining (CR) Total Knee System, it was confirmed that the endotoxin test reagent (PTS cartridge) and the laboratory environment were suitable for endotoxin test by the initial qualification test. Inhibition/enhancement Tests conclude that the product is suitable for endotoxin testing using both PTS readers and PTS cartridge, meeting both endotoxin standards and established criteria for testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K863668, K032163, K040267, K933785, K023211
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
November 9, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
OTIS Biotech Co., Ltd. Sanjay Lingot Research Scientist 15-118. Mtv Buk-ro, 193beon-gil Building 14, 2nd Floor, Siheung-Siheung-si, 15118 Korea
Re: K170534
Trade/Device Name: Prolixus™ Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 10, 2017 Received: October 10, 2017
Dear Mr. Lingot:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
PROLIXUS™ TOTAL KNEE SYSTEM
006. Indications for Use
510(k) Number:
Device Name: PROLIXUS™ TOTAL KNEE SYSTEM
Indications for Use:
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis,collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device system is designed for cement use only.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
007. 510 (k) Summary
[As Required by 21 CFR 807.87(h) & 21 CFR 807.92]
1. Submission information
Name of Company: OTIS Biotech Co., Ltd FDA registration No. 3005140381 15-118. MTV buk-ro, 193beon-gil, Building 14, 2nd floor, Siheung-si, Gyeonggi-do, Korea. Zip Code: 15118 Tel: 82-31-319-0406 Fax: 82-31-319-0414
Contact: Sanjay Lingot
E-mail: otis-1@otisbiotech.com Tel: + 82-31-319-0406 Cell No: + 82-10355-64618 Fax: + 82-31-319-0414
Prepared Date: 15-02-2017 Updated Date : 08-11-2017
2. Device Identification
| Trade Name: | PROLIXUS™ TOTAL KNEE SYSTEM |
|---|---|
| Common Name: | Cruciate Retaining Total Knee Replacement |
| Classification: | Class II (Special Control) |
| > 21 CFR 888.3560 - Knee Joint Patellofemorotibial | |
| Polymer/Metal/Polymer Semi-Constrained |
Product Code : JWH.
3. Substantial Equivalence Predicate Legally Marketed Devices
The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operational principles to the below listed predicate devices.
| Manufacturer | Device Name | Submission
Number | Clearance date |
|-------------------------------------------------------|----------------------------------|----------------------|----------------|
| Osteonics Corp | Omnifit® Total
Knee System | K863668 | 12/19/1986 |
| Stryker Orthopaedics
(Howmedica
Osteonics Corp) | Duracon® Total
Knee System | K032163 | 09/12/2003 |
| | Triathlon™
Cruciate Retaining | K040267 | 05/05/2004 |
4
| | (CR) Total Knee
System | | |
|--------------|--------------------------------------------------------------------|---------|------------|
| Zimmer, Inc | NexGen CR knee | K933785 | 30/01/1995 |
| | NexGen ( CR) -
Flex Femoral
components | K023211 | 17/10/2002 |
| Otis Biotech | MultiFitM Total Hip
System
(Instruments &
Sterilization ) | K101472 | 05/01/2011 |
| | ULC spinal pedicl
e screw system
(Instruments only ) | K083077 | 26/10/2009 |
4. Device Description
The Prolixus™ Cruciate Retaining (CR) Total Knee System consists of three primary components: Cruciate Retaining (CR) Femoral Component, Cruciate Retaining (CR) Tibial Insert, Patellar component and Tibial base plate.
The Prolixus™ CR components are described below:
PROLIXUSTMTotal Knee Cruciate Retaining (CR) Femoral Component
Prolixus™ Total Knee Cruciate Retaining (CR) Femoral Component is fabricated from cast cobalt-chromium-molybdenum alloy, and is intended for cemented application to replace the articulating surface of the distal femur. This cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present.
The Cruciate Retaining (CR) Femoral Component is available in right and left configurations, and six proportional sizes (sizes A to F) to accommodate differences in patient anatomy. The interior surface of the component is grit-blasted to increase surface roughness - this is intended to promote interdigitation of the polymethylmethacrylate (PMMA) bone cement with the surface texture and the apposing bone. This femoral component features cast-in pegs to help in femoral component placement, and to provide rotational stability.
PROLIXUS™ Cruciate Retaining (CR) Tibial Insert
The Cruciate Retaining (CR) Tibial Insert is neutral in configuration, and is available in six proportional sizes (sizes 1 to 6) and varying thicknesses (10mm, 12mm,14mm, 16mm, 18mm and 20 mm). The insert is fabricated from ultra high molecular weight polyethylene(medical grade PUR 1020 UHMPE) .The tibial insert is designed to accommodate the posterior cruciate ligament if it is present. There is a relief on the
5
anterior aspect of the tibial insert to accommodate the patellar tendon and patellar fat pad.
PROLIXUS™ Tibial base plate
Stem tibial baseplate components (tibial baseplate) are made from Ti-The angled 6Al-4V titanium alloy. Tibial baseplates are available in 6 sizes (1 to 6).
PROLIXUS™ | Patellar components
patellar component is made from ultra high molecular weight The polyethylene(medical grade PUR 1020 UHMPE). The patella is available in five diameters, 26mm, 29mm, 32mm, 35mm and 38mm, which permit optimal bone coverage and surgical options.
5. Indications for Use
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyar-thritis,collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device system is designed for cemented use only.
6. List of the Bench tests conducted
A. Test by EndoLab Mechanical Engineering GmbH
- 1.Fatigue test (Tibial base plate)
- 2.Knee constraint test
- 3.Knee Tibia and inserter component interlock strength test
- 4.Knee Femoral and Tibial insert contact area/pressure
- distribution test
- 5.Knee Femoral and Patella contact area/pressure distribution
- 6.Knee geometry and surfaces
- 7.Range of motion CAD analysis
B. Greenpia Technology, South Korea
-
- Bacterial endotoxins test (BET), also known as the Lims Amebocyte Lysate (LAL) test)
C. Summary & Conclusions fromTestings
-
- Fatigue test (Tibial base plate)
Five tibial trays tested herein at a maximum load of 900 N (200 lbs) passed 10 million load cycles without failure and therefore meet the suggested minimum
- Fatigue test (Tibial base plate)
6
fatigue strength by the ISO 21536.This results in a max. run- out bending moment of 22.5 Nm.
2. Knee constraint test
Anterior-posterior constraint test
The knee implant tested by the constraint test was found to withstand at 0° flexion a mean anterior load of -348 N (StdDev 9) and a mean posterior load of 149 N (StdDev4).
The knee implant tested by the constraint test was found to withstand at 15° flexion a mean anterior load of -348 N (StdDev12) and a mean posterior load of 147 N (StdDev2).
The knee implant tested by the constraint test was found to withstand at 90° flexion a mean anterior load of -349 N (StdDev3) and a mean posterior load of 154 N (StdDev4).
The knee implant tested by the constraint test was found to withstand at 135° flexion a mean anterior load of -331 N (StdDev5) and a mean posterior load of 152 N (StdDev4).
Medial lateral constraint test
The knee implant tested by the constraint test was found to withstand at 0° flexion a mean lateral load of -396 N (StdDev3) and a mean medial load of 387 N (StdDev6).
The knee implant tested by the constraint test was found to withstand at 15° flexion a mean lateral load of -385 N (StdDev7) and a mean medial load of 383 N (StdDev3).
The knee implant tested by the constraint test was found to withstand at 90° flexion a mean lateral load of -415 N (StdDev3) and a mean medial load of 365 N (StdDev3).
The knee implant tested by the constraint test was found to withstand at 135° flexion a mean lateral load of -370 N (StdDev21) and a mean medial load of 413 N (StdDev5).
Internal-external rotation constraint test
The knee implant tested by the constraint test was found to withstand at 0° flexion a mean external torque of -5.7 Nm (StdDev 0.4) and a mean internal torque of 5.8 Nm (StdDev 0.2).
The knee implant tested by the constraint test was found to withstand at 15° flexion a mean external torque of -6.2 Nm (StdDev 0.3) and a mean internal torque of 5.8 Nm (StdDev 0.1).
The knee implant tested by the constraint test was found to withstand at 90° flexion a mean external torque of -5.4 Nm (StdDev 0.1) and a mean internal torque of 6.3 Nm (StdDev 0.1).
The knee implant tested by the constraint test was found to withstand at 135° flexion a mean external torque of -5.1 Nm (StdDev 0.4) and a mean internal torque of 5.7Nm (StdDev 0.1).
7
3. Knee Tibia and inserter component interlock strength test i. Disassembly Test by Anterior/Posterior Loading
- A total of six specimens were tested for tibial insert and tibial baseplate a. assembly in anteriorposterior loading direction. In this loading direction the established mean assembly load was found to be 138 N (StdDev 22). An additional orthogonal load was found required for complete assembly.
- b. A total of six specimens were tested for tibial insert and tibial baseplate disassembly in posterioranterior loading direction. In this loading direction the established mean disassembly load was found to be 1,459 N (StdDev 31). Plastic deformation of the snap-in locking mechanism was found as failure mode.
Disassembly Test by Medial/Lateral Loading ii.
One tibial insert and tibial baseplate assembly loaded in medial-lateral load direction was found to withstand loads > 754 N. At this load the point of load application was plastically deformed and test was stopped. No failure at the interconnection mechanism between the tibial insert and the tibial baseplate was found.
One tibial insert and tibial baseplate assembly loaded in lateral-medial load direction was found to withstand loads > 720 N. At this load the point of load application was plastically deformed and test was stopped. No failure at the interconnection mechanism between the tibial insert and the tibial baseplate was found.
Disassembly Test by Pull-off Loading iii.
Tibial insert and tibial baseplate assemblies loaded in tensile mode was found to withstand a mean ultimate load of 2,015 N (StdDev 187) without the ability of tibia tilt.
Assembly Test in anteriorposterior direction iv.
A total of five specimens were tested for tibial insert and tibial baseplate assembly in anteroposterior loading direction with a tibial baseplate inclination of 70°(30° in top). In this loading direction a mean assembly load of 132 N (StdDev. 24) was determined at a displacement of 4.5 mm.
Disassembly Test in anteriorposterior direction and lateral direction V.
A total of five specimens were tested for tibial insert and tibial baseplate disassembly in anterior to posterior loading direction. In this loading direction a mean ultimate disassembly load of 804 N (StdDev. 70) was determined.
4. Knee Femoral and Tibial insert contact area/pressure distribution test
The area of the contact stresses above 20 MPa found corresponds to typical findings. A direct comparison to the EndoLab database (n=19 test series) can be found.Please note that the data comprises different designs and implant sizes. It can be stated that the contact stresses and total contact areas of implant tested herein are within the common range of the predicate devices.
8
5. Knee Femoral and patella contact area/pressure distribution
The aim of the test performed was to evaluate the pressure distribution and total contact area of the patella-femoral components under different flexion angles and loads.The smallest total contact area of the patella-femoral joint was 20.44 mm² (SD 0.29 mm2) at 15° flexion and the largest total contact area was 86.87 mm² (SD 0.92 mm²) at 135° flexion.The smallest contact area above 20 MPa was 11.61 mm² (SD 0.50 mm2) at 15° flexion and the highest contact area above 20 MPa was 66.07 mm² (SD 1.35 mm²) at 135° flexion.
6. Knee geometry and surfaces
Femoral component-
In accordance to ISO 7207-2 the articulating surface roughness has been described by the parameters Ra, Rz and Rt for five femoral components. Related to the demands of ISO 7207-1 the geometric dimensions were determined for the same five femoral components
Surface finish:
A total mean Ra value of 0.013 µm (Std. Dev. 0.001 µm) was measured. A total mean Rz value of 0.194 um (Std.Dev. 0.279 um) was measured. A total mean Rt value of 0.127 µm (Std.Dev. 0.003 µm) was measured. Referenced to the surface finish requirements according to ISO 7207-2 no femoral component exceeded a roughness value Ra grated than 0.1 µm.
Tibia base component-
The purpose of this analysis was to determine the geometric dimensions of five tibial trays according to ISO 7207-1 and to determine the surface roughness at the femoral surface of the tibial trays.
Surface finish:
A total mean Ra value of 0.62 um (Std. Dev. 0.078 um) was measured. A total mean Rz value of 3.37 um (Std.Dev. 0.410 um) was measured. A total mean Rt value of 5.05 µm (Std.Dev. 0.954 µm) was measured.
Tibia insert component-
The purpose of this analysis was to determine the minimum thickness of five unconstrained bi compartmental (fixed bearing) tibial inserts and to determine the surface roughness at the load bearing side of the tibial inserts. Surface finish:
An overall mean Ra value of 0.212 um (Std. Dev. 0.079 um) was measured. An overall mean Rz value of 1.084 um (Std. Dev. 0.391 um) was measured. An overall mean Rt value of 1.776 um (Std. Dev. 0.598 um) was measured.
Referenced to the surface finish requirements according to ISO 7207-2 , no insert exceeded a roughness value Ra greater than 2.0 µm. The surface roughness values determined for each insert at the different locations are shown
9
Minimum thickness:
A total mean lateral thickness of 6.77 mm (Std. Dev. 0.05 mm) and a total mean medial thickness of 6.77 (Std. Dev. 0.05 mm) have been determined.
ISO 21536: 2007 (Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants) requires a minimum thickness in the load bearing area of 6 mm for components having a tibial tray. None of the inserts analyzed showed a minimum thickness smaller than 6 mm .
Patella component-
In accordance to ISO 7207-2 the interested articulating surface roughness has been determined by the parameters Ra, Rz and Rt for six patella components. Related to the demands of ISO 7207-1 the minimum thicknesses of have been
determined for the same six patella components listed above.
Surface finish:
An overall mean Ra value of 0.79 µm (Std. Dev. 0.20 µm), an overall mean Rz value of 3.20 µm (Std.Dev. 0.65 µm) and an overall mean Rt value of 4.18 µm (Std. Dev. 0.98 um) were determined.Referenced to the surface finish requirements according to ISO 7207-2 (see section 5.1) no patella component exceeded a roughness value Ra greater than 2.0 um. The surface roughness values determined for each patella component at the different locations are shown .
Minimum thickness and width dimensions:
An overall mean thickness of 8.01 mm (Std. Dev. 0.05 mm) and an overall mean width of 25.98 (Std.Dev. 0.02 mm) have been determined.
7. Range of motion CAD analysis
A CAD analysis of the TKR Otis Size 1 system has been performed using IGES files .A total of four different rotations/translations have been investigated: Flexion/extension, rotation,medial-lateral and anterior posterior translation. In addition, the medial as well as the lateral contact point have been investigated for seven different flexion angles. All motions observed correspond to typical findings as expected for fixed type bearings. The sliding/rolling analysis supports the common theory of mixed sliding/rolling articulations for this type of bearing. Varus/valgus rotation and proximal/distal translation are not constrained by this type of implant and have not been simulated. Due to the low degree of constraint, different types of articulating motions are expected in-vivo depending on the soft tissue balance, the muscular status as well as the daily living activities of the patient. The analysis of the kinematics presented herein therefore should be regarded as average positioning within an array of possible motions.
8. Pyrogen and Endotoxins Testing : Bacterial endotoxins test (BET), also known as the Limulus amebocyte lysate (LAL) test) :
As a result of endotoxin test validation for thThe PROLIXUS™ Cruciate Retaini ng (CR) Total Knee System, it was confirmed that the endotoxin test reagent (PTS
10
cartridge) and the laboratory environment were suitable for endotoxin test by the initial qualification test. Inhibition/enhancement Tests conclude that the product is suitable for endotoxin testing using both PTS readers and PTS cartridge, meeting both endotoxin standards and established criteria for testing.
11
7. Summary of the technological similarities of the new device in comparison to those of the predicate device
| Parameter | OTIS Biotech.
PROLIXUS™ Knee system | Osteonics Corp
Omnifit® Total Knee System | Stryker Orthopaedics
(Howmedica Osteonics Corp)
Triathlon™ (CR) Total Knee System
Duracon® Total Knee System | Zimmer, Inc
NexGen CR and
(CR)-Flex knee | Remark |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Product
Code | JWH | JWH | JWH ,MBH | JWH | Similar with
predicate
device |
| Indication
for Use | 1.knee arthroplasty for reduction or relief of
pain
2. Improved knee function in skeletally
mature patients
3. knee pain and disability due to
rheumatoid arthritis
3.Osteoarthritis, primary and secondary
traumatic arthritis
4.Polyar-thritis,collagen disorders, avascular | | 1.Painful, disabling joint disease of
the knee resulting from: non
inflammatory degenerative joint
disease (including osteoarthritis,
traumatic arthritis or avascular
necrosis) or rheumatoid arthritis
2. Post-traumatic loss of knee joint
configuration and function
3. Moderate varus, valgus or | 1.knee arthroplasty for
reduction or relief of pain
2. Improved knee function in
skeletally mature patients
3. knee pain and disability due
to rheumatoid arthritis
3.Osteoarthritis, primary and
secondary traumatic arthritis
4.Polyar-thritis,collagen | Similar with
predicate
device |
12
| necrosis of the femoral condyle
5.Pseudogout, osttraumatic loss of joint
configuration
6. Patellofemoral erosion, dysfunction
7. Moderate valgus, varus, or flexion
deformities
8. Device system is designed for cemented
use only. | flexion deformity in which the
ligamentous structures can be
returned to adequate function and
stability
4. Revision of previous
unsuccessful knee replacement or
other procedure
5. Fracture of the distal femur
and/or proximal tibia that cannot
be stabilized by standard fracture
management techniques
Duracon knee products are
intended to achieve fixation
with and without bone
cement | disorders, avascular necrosis of
the femoral condyle
5.Pseudogout, osttraumatic loss
of joint configuration
- Patellofemoral erosion,
dysfunction - Moderate valgus, varus, or
flexion deformities - Device system is designed for
cemented use only. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
13
PROLIXUS™ TOTAL KNEE SYSTEM
- 510(k) Summary
Premarket Notification 510(k)
| Intended
for Cement
use only | Yes | yes | > Duracon knee products are
intended to achieve fixation
with and without bone
cement | yes | Similar with
predicate
device |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Design and
components | Knee design contains
Femoral component
Tibial component
UHMWPE inserter
patella component
Femoral component- 6 sizes of Left and
right side components
-AP-52,56,60,64,68,72 mm and ML-
56,60,64,68,72,76 mm
Tibial component- 6sizes of tibial component
-AP-42,44.5,47,50.5,50.5,55.5 mm and ML-
63,67,71,71,80,80 mm
UHMWPE insert- 6 sizes of inserter
components | Design is almost similar
except in component sizes
and liner inter locking
system between Tibia base
plate and UHMWPE | The Triathlon CR Total Knee
System consists of femoral
component tibial insert, and all
polyethylene patellar components
that are intended to be used with
previously cleared Triathlon
Primary Cemented Tibial Tray in
primary or revision total knee
arthroplasty. The Triathlon All
Polyethylene Patellar components
are intended to be used with
femoral components of the
previously released Triatihlon PS
femoral components of the | Knee design contains
Femoral component
Tibial component
UHMWPE inserter
patella component
Design is almost similar except
in component sizes and liner
inter locking system between
Tibia base plate and UHMWPE | Design is
almost similar
except in
component
sizes and
Tibia base
plate and
UHMWPE
liner inter
locking |
| | -AP-42,44.5,47,50.5,50.5,55.5 mm and ML- 63,67,71,71,80,80 mm
Patella component- 5 sizes of patella component
- Patella-XS(d=26&t=8),
Patella-S(d=29&t=8.5),
Patella-M(d=32&t=8.5),
Patella-L(d=35&t=9),
Patella-XL(d=38&t=9.5) | previously released Druacon Total Knee System, as well as the previously released Triathlon PS femoral component in situations where replacement of the articular surface of the patella is required. The Triathlon CR Total Knee System is intended to accommodate the posterior circulate ligament (PCL) if it is present. Components:
Femoral Component Tibial Implant
Tibial Implant
Metal backed tibial component
Patellar component | | system | |
| ROM | 0° to 135° | > Duracon knee system- 0° to 130° | NexGen
CR knee system-0° to | Similar with predicate | 0° to 115° |
| Materials | > Femoral- Cast CoCr to ISO 5832-4 /
ASTM F75
Tibia- Ti-6Al-4V ASTM F.136-ISO 5832/3
UHMWPE insert- GUR 1020
Patella component- GUR 1020 | > Femoral- Cast CoCr to ISO 5832-4 / ASTM F75
Tibia- Ti-6Al-4V ASTM F.136-ISO 5832/3
UHMWPE insert- GUR 1020
Patella component- GUR 1020 | > Triathlon™ (CR) Total
Knee System-0° to 150°
Femoral Implant CoCrMo
Metal-Backed Tibial Components;
Tibial tray-CoCrMo
Tibial Insert-UHMWPE with CoCrMo locking wire
All Polymer Patellar Component-(UHMWPE) | 120°
CR-flex knee system-0° to 155°
Femoral- Cast CoCr to ISO 5832-4 / ASTM F75
Tibia- Ti-6Al-4V ASTM F.136-ISO 5832/3
UHMWPE insert- GUR 1020
Patella component- GUR 1020 | device range
Similar with predicate device |
| Principle of Operation | Cemented use fixed bearing design | Cemented use fixed bearing design | Same and Duracon knee system used with and without cement | Cemented use fixed bearing design | Similar with predicate device |
Artificial Joint Research Center ©OTISBiotech co., Ltd.
14
- 510(k) Summary
Premarket Notification 510(k)
Artificial Joint Research Center ©OTISBiotech co., Ltd.
15
16
- 510(k) Summary
| Sterility | Gamma sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | Similar with
predicate
device |
|-----------|---------------------|---------------------|---------------------|---------------------|-------------------------------------|
| | | | | | |
| | | | | | |
Premarket Notification 510(k)
17