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.

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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "PROLIXUS™ TOTAL KNEE SYSTEM". This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through bench testing comparing the new device's mechanical properties, materials, and design to established standards and predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit from ISO/Standard)	Reported Device Performance
Fatigue Test (Tibial Base Plate)	ISO 21536 suggested minimum fatigue strength (10 million load cycles at 900 N without failure)	Five tibial trays passed 10 million load cycles at 900 N without failure. Max run-out bending moment of 22.5 Nm.
Knee Constraint Test (Anterior-Posterior)	Implied to be comparable to predicate devices and within expected physiological ranges for stability.	0° flexion: Mean anterior load -348 N (StdDev 9), posterior load 149 N (StdDev 4).15° flexion: Mean anterior load -348 N (StdDev 12), posterior load 147 N (StdDev 2).90° flexion: Mean anterior load -349 N (StdDev 3), posterior load 154 N (StdDev 4).135° flexion: Mean anterior load -331 N (StdDev 5), posterior load 152 N (StdDev 4).
Knee Constraint Test (Medial-Lateral)	Implied to be comparable to predicate devices and within expected physiological ranges for stability.	0° flexion: Mean lateral load -396 N (StdDev 3), medial load 387 N (StdDev 6).15° flexion: Mean lateral load -385 N (StdDev 7), medial load 383 N (StdDev 3).90° flexion: Mean lateral load -415 N (StdDev 3), medial load 365 N (StdDev 3).135° flexion: Mean lateral load -370 N (StdDev 21), medial load 413 N (StdDev 5).
Knee Constraint Test (Internal-External Rotation)	Implied to be comparable to predicate devices and within expected physiological ranges for stability.	0° flexion: Mean external torque -5.7 Nm (StdDev 0.4), internal torque 5.8 Nm (StdDev 0.2).15° flexion: Mean external torque -6.2 Nm (StdDev 0.3), internal torque 5.8 Nm (StdDev 0.1).90° flexion: Mean external torque -5.4 Nm (StdDev 0.1), internal torque 6.3 Nm (StdDev 0.1).135° flexion: Mean external torque -5.1 Nm (StdDev 0.4), internal torque 5.7 Nm (StdDev 0.1).
Knee Tibia and Inserter Component Interlock Strength (Disassembly - AP Loading)	Implied to be sufficient to prevent unintended disassembly during expected use.	Mean assembly load 138 N (StdDev 22). Mean disassembly load 1,459 N (StdDev 31). Failure mode: plastic deformation of snap-in locking mechanism.
Knee Tibia and Inserter Component Interlock Strength (Disassembly - ML Loading)	Implied to be sufficient to prevent unintended disassembly during expected use.	Withstood loads > 754 N (medial-lateral) and > 720 N (lateral-medial) with plastic deformation at load application point, no failure of interconnection mechanism.
Knee Tibia and Inserter Component Interlock Strength (Disassembly - Pull-off Loading)	Implied to be sufficient to prevent unintended disassembly during expected use.	Mean ultimate load 2,015 N (StdDev 187) without tibia tilt.
Knee Tibia and Inserter Component Interlock Strength (Assembly - AP Direction with tilt)	Implied to be within acceptable range for surgical assembly.	Mean assembly load of 132 N (StdDev 24) at 4.5 mm displacement.
Knee Tibia and Inserter Component Interlock Strength (Disassembly - AP and Lateral Direction)	Implied to be sufficient to prevent unintended disassembly during expected use.	Mean ultimate disassembly load of 804 N (StdDev 70).
Knee Femoral and Tibial Insert Contact Area/Pressure Distribution	Contact stresses and total contact areas fall within the common range of predicate devices (from EndoLab database of 19 test series).	Contact stresses and total contact areas are within the common range of predicate devices.
Knee Femoral and Patella Contact Area/Pressure Distribution	Implied to be comparable to predicate devices and expected physiological performance.	Smallest total contact area: 20.44 mm² (SD 0.29 mm²) at 15° flexion. Largest total contact area: 86.87 mm² (SD 0.92 mm²) at 135° flexion. Smallest contact area above 20 MPa: 11.61 mm² (SD 0.50 mm²) at 15° flexion. Highest contact area above 20 MPa: 66.07 mm² (SD 1.35 mm²) at 135° flexion.
Femoral Component Surface Finish	Ra < 0.1 µm as per ISO 7207-2.	Total mean Ra: 0.013 µm (Std. Dev. 0.001 µm). None exceeded 0.1 µm.
Tibial Base Component Surface Finish	Not explicitly stated but implied to be acceptable for comparison to predicate devices.	Total mean Ra: 0.62 µm (Std. Dev. 0.078 µm).
Tibia Insert Component Surface Finish	Ra < 2.0 µm as per ISO 7207-2.	Overall mean Ra: 0.212 µm (Std. Dev. 0.079 µm). None exceeded 2.0 µm.
Tibia Insert Component Minimum Thickness	Minimum thickness 6 mm in load-bearing area as per ISO 21536:2007.	Total mean lateral thickness: 6.77 mm (Std. Dev. 0.05 mm). Total mean medial thickness: 6.77 mm (Std. Dev. 0.05 mm). None smaller than 6 mm.
Patella Component Surface Finish	Ra < 2.0 µm as per ISO 7207-2.	Overall mean Ra: 0.79 µm (Std. Dev. 0.20 µm). None exceeded 2.0 µm.
Patella Component Minimum Thickness and Width	Implied to be appropriate for surgical use and comparison to predicate devices.	Overall mean thickness: 8.01 mm (Std. Dev. 0.05 mm). Overall mean width: 25.98 mm (Std. Dev. 0.02 mm).
Range of Motion CAD Analysis	Motions correspond to typical findings for fixed-type bearings; supports mixed sliding/rolling articulations theory.	All motions observed correspond to typical findings. Sliding/rolling analysis supports common theory of mixed sliding/rolling articulations.
Bacterial Endotoxins Test (BET/LAL)	Product is suitable for endotoxin testing, meeting endotoxin standards and established criteria for testing.	Test validation confirmed suitability of reagent (PTS cartridge) and laboratory environment. Inhibition/enhancement tests concluded product is suitable for endotoxin testing.

2. Sample Size Used for the Test Set and the Data Provenance

The "studies" described are primarily bench tests conducted on physical device components.

Fatigue Test (Tibial base plate): 5 tibial trays.
Knee Constraint Test: Specific number not explicitly stated for each measurement, but implied to be multiple units as "mean" and "StdDev" are reported.
Knee Tibia and Inserter Component Interlock Strength:
- Disassembly Test by Anterior/Posterior Loading: 6 specimens for assembly, 6 specimens for disassembly.
- Disassembly Test by Medial/Lateral Loading: 2 specimens (one for medial-lateral, one for lateral-medial).
- Disassembly Test by Pull-off Loading: Not explicitly stated, but statistical data suggests multiple specimens.
- Assembly Test in anteriorposterior direction: 5 specimens.
- Disassembly Test in anteriorposterior direction and lateral direction: 5 specimens.
Knee Femoral and Tibial insert contact area/pressure distribution test: Not explicitly stated, but compared to an "EndoLab database (n=19 test series)."
Knee Geometry and Surfaces:
- Femoral component: 5 components.
- Tibia base component: 5 tibial trays.
- Tibia insert component: Not explicitly stated, but discussed for "each insert" and statistical data provided.
- Patella component: 6 patella components.
Bacterial Endotoxins Test (BET/LAL): Not explicitly stated, but validation testing was performed.

Data Provenance: The studies were conducted by "EndoLab Mechanical Engineering GmbH" (likely Germany) and "Greenpia Technology, South Korea" (South Korea). The data is retrospective in the sense that it's laboratory bench testing of the manufactured device components, not data collected from patients. There is no mention of patient data or country of origin for such data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. These are bench tests against engineering standards and internal databases, not clinical studies requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" for these tests is the specified ISO standard (e.g., ISO 21536, ISO 7207-2) or established engineering principles.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring adjudication of expert readings. Test results are quantitative measurements against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document does not pertain to an AI or diagnostic imaging device. It describes a total knee replacement system, a physical medical device. MRMC studies are not relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth used for these bench tests included:

International Standards: e.g., ISO 21536 for fatigue strength and minimum thickness, ISO 7207-2 for surface roughness, ISO 7207-1 for geometric dimensions.
Internal Databases/Predicate Device Data: For contact area/pressure distribution, the device performance was compared to an "EndoLab database (n=19 test series)" which contained data from predicate devices.
Engineering Specifications: Implied acceptable ranges for mechanical loads, torques, and material properties.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical implant, not a machine learning model. There is no "training set." The design and manufacturing processes are likely informed by prior engineering knowledge and predicate device designs.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a machine learning model. The "ground truth" for the design and testing of a knee implant is based on established biomechanical principles, material science, clinical needs, and performance of existing devices (predicates).

Summary

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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

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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

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PROLIXUS™ TOTAL KNEE SYSTEM

006. Indications for Use

510(k) Number:

Device Name: PROLIXUS™ TOTAL KNEE SYSTEM

Indications for Use:

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)

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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 PatellofemorotibialPolymer/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	SubmissionNumber	Clearance date
Osteonics Corp	Omnifit® TotalKnee System	K863668	12/19/1986
Stryker Orthopaedics(HowmedicaOsteonics Corp)	Duracon® TotalKnee System	K032163	09/12/2003
	Triathlon™Cruciate Retaining	K040267	05/05/2004

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	(CR) Total KneeSystem
Zimmer, Inc	NexGen CR knee	K933785	30/01/1995
	NexGen ( CR) -Flex Femoralcomponents	K023211	17/10/2002
Otis Biotech	MultiFitM Total HipSystem(Instruments &Sterilization )	K101472	05/01/2011
	ULC spinal pedicle screw system(Instruments only )	K083077	26/10/2009

4. Device Description

The Prolixus™ CR components are described below:

PROLIXUSTMTotal Knee Cruciate Retaining (CR) Femoral Component

PROLIXUS™ Cruciate Retaining (CR) Tibial Insert

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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

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

1. Bacterial endotoxins test (BET), also known as the Lims Amebocyte Lysate (LAL) test)

C. Summary & Conclusions fromTestings

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

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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).

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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.

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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

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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

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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.

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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 CorpOmnifit® Total Knee System	Stryker Orthopaedics(Howmedica Osteonics Corp)Triathlon™ (CR) Total Knee SystemDuracon® Total Knee System	Zimmer, IncNexGen CR and(CR)-Flex knee	Remark
ProductCode	JWH	JWH	JWH ,MBH	JWH	Similar withpredicatedevice
Indicationfor Use	1.knee arthroplasty for reduction or relief ofpain2. Improved knee function in skeletallymature patients3. knee pain and disability due torheumatoid arthritis3.Osteoarthritis, primary and secondarytraumatic arthritis4.Polyar-thritis,collagen disorders, avascular		1.Painful, disabling joint disease ofthe knee resulting from: noninflammatory degenerative jointdisease (including osteoarthritis,traumatic arthritis or avascularnecrosis) or rheumatoid arthritis2. Post-traumatic loss of knee jointconfiguration and function3. Moderate varus, valgus or	1.knee arthroplasty forreduction or relief of pain2. Improved knee function inskeletally mature patients3. knee pain and disability dueto rheumatoid arthritis3.Osteoarthritis, primary andsecondary traumatic arthritis4.Polyar-thritis,collagen	Similar withpredicatedevice

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necrosis of the femoral condyle5.Pseudogout, osttraumatic loss of jointconfiguration6. Patellofemoral erosion, dysfunction7. Moderate valgus, varus, or flexiondeformities8. Device system is designed for cementeduse only.	flexion deformity in which theligamentous structures can bereturned to adequate function andstability4. Revision of previousunsuccessful knee replacement orother procedure5. Fracture of the distal femurand/or proximal tibia that cannotbe stabilized by standard fracturemanagement techniques> Duracon knee products areintended to achieve fixationwith and without bonecement	disorders, avascular necrosis ofthe femoral condyle5.Pseudogout, osttraumatic lossof joint configuration6. Patellofemoral erosion,dysfunction7. Moderate valgus, varus, orflexion deformities8. Device system is designed forcemented use only.
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PROLIXUS™ TOTAL KNEE SYSTEM

510(k) Summary

Premarket Notification 510(k)

Intendedfor Cementuse only	Yes	yes	> Duracon knee products areintended to achieve fixationwith and without bonecement	yes	Similar withpredicatedevice
Design andcomponents	Knee design contains> Femoral component> Tibial component> UHMWPE inserter> patella componentFemoral component- 6 sizes of Left andright side components-AP-52,56,60,64,68,72 mm and ML-56,60,64,68,72,76 mmTibial 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 mmUHMWPE insert- 6 sizes of insertercomponents	Design is almost similarexcept in component sizesand liner inter lockingsystem between Tibia baseplate and UHMWPE	The Triathlon CR Total KneeSystem consists of femoralcomponent tibial insert, and allpolyethylene patellar componentsthat are intended to be used withpreviously cleared TriathlonPrimary Cemented Tibial Tray inprimary or revision total kneearthroplasty. The Triathlon AllPolyethylene Patellar componentsare intended to be used withfemoral components of thepreviously released Triatihlon PSfemoral components of the	Knee design contains> Femoral component> Tibial component> UHMWPE inserter> patella componentDesign is almost similar exceptin component sizes and linerinter locking system betweenTibia base plate and UHMWPE	Design isalmost similarexcept incomponentsizes andTibia baseplate andUHMWPEliner interlocking
	-AP-42,44.5,47,50.5,50.5,55.5 mm and ML- 63,67,71,71,80,80 mmPatella 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) TotalKnee 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 rangeSimilar 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

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510(k) Summary

Premarket Notification 510(k)

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510(k) Summary

Sterility	Gamma sterilization	Gamma sterilization	Gamma sterilization	Gamma sterilization	Similar withpredicatedevice

Premarket Notification 510(k)

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Regulation Number and Section

§ 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.