A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The porous coated (CoCr beads with Titanium) femoral and tibial components may be used with or without cement.

Device Description

The Consensus Total Knee System (CKS) is a primary fixed-bearing total knee system that has been on the market since 1990's.

The CKS has been designed to replicate the natural anatomy of the knee in order to restore knee function. It has been developed to preserve and utilize healthy ligamentous structures. For cases where the soft tissues are not functional, the PCL substituting tibial inserts or the posterior stabilized system are available for increased stability.

The CKS incorporates femoral, tibial, and patellar components and all associated instrumentation needed for implantation. The CKS can be used for total knee replacement with posterior cruciate ligament (PCL) retaining or substituting.

The femoral components are provided in left and right side versions and are designed to replicate natural kinematic motion between the femur, tibia and patella. The Consensus femoral component is designed to provide uniform contact zones in the coronal plane throughout the range of motion when the knee is properly aligned. The femoral component is also designed with a large distal radius to optimize contact areas and reduce contact stress. The trochlear groove in the femur is designed to allow the load from the patella to be evenly distributed on the femur with adequate lateral constraint.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

Acceptance Criteria and Device Performance for Consensus® Knee System (K102927)

This submission (K102927) is primarily to expand the indications for the already cleared Consensus® Knee System (CKS) porous-coated components to allow for uncemented use. The non-clinical performance data provided specifically addresses the porous coating's mechanical and chemical properties, demonstrating its suitability for this expanded use.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document includes a clear table outlining the specifications, acceptance criteria, and verification results for the modified surface (porous CoCr bead with Ti coating).

Specification	Acceptance Criteria	Verification Results
Microstructure of the modified surface	N/A	Bead to Bead Neck Diameter: 0.33 mm
		Pore Size: 0.432 mm
		Volume % Porosity: 37%
		Coating Thickness: 0.889 mm
Corrosion of the modified surface (shall be equal or less than that measured in a legally marketed device)	Equal to or improved corrosion resistance when compared with CoCr beads using ASTM F746 & G61	Critical Potential (CoCr Beads): 1290 mV; Breakdown Potential: 1200 mV
		Critical Potential (Ti Coated CoCr Beads): 1315 mV; Breakdown Potential: 1200 mV
Modified surface shall exhibit adequate static tensile strength	The static tensile strength will exceed 20 MPa.	Static Tensile Strength: 58.32 MPa
Modified surface shall exhibit adequate static shear strength	The static shear strength will exceed 20 MPa.	Static Shear Strength: 58.32 MPa
Modified surface shall exhibit adequate shear fatigue strength	The shear fatigue strength will exceed 10 million cycles.	10 million cycles achieved with a strength of 13.78 MPa
Modified surface shall exhibit adequate rotating beam fatigue strength	The rotating beam fatigue strength will exceed 10 million cycles.	10 million cycles achieved with a strength of 206.7 MPa
Modified surface shall not exhibit excessive abrasion	N/A	200N load: Avg. mass loss 0.006 g, Avg. thickness loss 6%
		1500N load: Avg. Mass loss 0.179 g, Avg. thickness loss 23%

Note: For microstructure and abrasion, the "Acceptance Criteria" are listed as "N/A" in the table, indicating these are descriptive measurements rather than pass/fail thresholds in this summary. However, the reported values are provided as verification results. For corrosion, the results for both CoCr beads and Ti Coated CoCr Beads demonstrate a comparable or improved resistance against the breakdown potential.

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

The document describes non-clinical performance data which typically involves laboratory testing of materials and components, not clinical data from patients. Therefore, terms like "test set" in the context of patient data, "country of origin of the data," or "retrospective/prospective" studies are not applicable here.

The sample sizes for the mechanical and corrosion tests are not explicitly stated in this summary. It's common in such submissions for the detailed test reports (which would include sample sizes, testing methodologies, and raw data) to be referenced but not fully reproduced in the 510(k) summary. These tests are performed on material coupons or device components in a laboratory setting.

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

This question is not applicable to this submission. The "test set" here refers to material samples or device components tested in a lab. The "ground truth" is established by direct physical and chemical measurements (e.g., measuring dimensions, applying forces, assessing corrosion) using standardized test methods (like ASTM standards mentioned). Therefore, human expert consensus on image interpretation or clinical outcomes is not relevant for this type of non-clinical data.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts when establishing ground truth, typically in clinical studies or image review. Since this involves non-clinical laboratory testing, there is no human adjudication process of this nature.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This type of study assesses how human readers' diagnostic performance changes with and without AI assistance, which is irrelevant for a submission concerning the material properties and expanded uncemented use of a knee implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone algorithm performance study was done. This typically refers to the performance of an AI algorithm on its own. The Consensus® Knee System is a medical device (a knee implant), not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for this non-clinical performance data is direct physical and chemical measurement against predefined specifications and ASTM standards. This includes:

Physical dimensions and morphology (e.g., bead neck diameter, pore size, coating thickness).
Electrochemical properties (e.g., critical potential, breakdown potential for corrosion resistance).
Mechanical properties (e.g., static tensile strength, static shear strength, shear fatigue strength, rotating beam fatigue strength, mass and thickness loss from abrasion).

8. Sample Size for the Training Set

This question is not applicable. There is no AI model or algorithm being trained within the scope of this 510(k) submission. The data presented are for validating the material properties of the porous coating.

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

This question is not applicable, as there is no training set mentioned or implied in the context of this device submission.

Summary

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2. 510(k) SUMMARY

Sponsor Name:	Consensus Orthopedics, Inc.1115 Windfield Way, Suite 100El Dorado Hills, CA 95762	JAN 2 6 2011
510(k) Contact:	Matthew M. Hull, RACPhone: (916) 355-7156/ Fax: (916) 355-7190mhull@consensusortho.com
Date Prepared:	30 September, 2010
Trade Name:	Consensus® Knee System
Common Name:	Porous-coated knee prosthesis for cemented or cementless use
Classification Name:	Knee joint patellofemorotibial metal/polymer/metal semi-constrained cemented prosthesis is a class II device per 21 CFR888.3560 (Product Code JWH)
	Knee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis is a Class II device per 21 CFR888.3565 (Product Code MBH)
Review Panel:	Orthopedic Devices

Device Description:

The Consensus Total Knee System (CKS) is a primary fixed-bearing total knee system that has been on the market since 1990's.

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contact stress. The trochlear groove in the femur is designed to allow the load from the patella to be evenly distributed on the femur with adequate lateral constraint.

Indications for Use:

The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The porous coated (CoCr beads with Titanium) femoral and tibial components may be used with or without cement.

Substantial Equivalence:

The CKS porous coated components that are the subject of this submission were previously cleared by FDA for cemented use in K001456 (femoral components) and K983004 (tibial components). This submission is to expand the indications to allow their uncemented use. The previous 510(k)'s for these devices were cleared prior to the change in our company's name from Hayes Medical, inc. to Consensus Orthopedics. Inc. in 2008. The CKS implants are also substantially equivalent to the following knee systems that are cleared for cementless use: Smith & Nephew's "ProFix Total Knee" (K051229 & K030623), Biomet's "AGC Total Knee" (K033489), and Zimmer's "Natural Knee" (K073286 & K070214).

Non-Clinical Performance Data:

Modified Surface Testing Specifications and Results:

The porous CoCr bead with Ti coating surface that is being indicated for cementless use is identical to the porous surface that was approved in K001456 and K983004. Below is a summary of the testing related to the porous coating.

Specification	Acceptance Criteria	Verification Results
Microstructure of themodified surface	N/A	Bead to Bead Neck Diameter 0.33 mm
		Pore Size0.432 mm
		Volume % Porosity37%
		Coating Thickness0.889 mm
Corrosion of the modifiedsurface shall be equal of lessthan that measured in alegally marketed device.	Equal to or improvedcorrosion resistance whencompared with CoCr beadsusing ASTM F746 & G61	Critical PotentialCoCr Beads 1290 mV	Breakdown Potential1200 mV
		Ti CoatedCoCr Beads 1315 mV	1200 mV
Modified surface shallexhibit adequate statictensile strength	The static tensile strengthwill exceed 20 MPa.	Static Tensile Strength of58.32 MPa

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Modified surface shallexhibit adequate static shearstrength.	The static shear strengthwill exceed 20 MPa.	Static Shear Strength of58.32 MPa
Modified surface shallexhibit adequate shearfatigue strength.	The shear fatigue strengthwill exceed 10 millioncycles.	10 million cycles achieved witha strength of 13.78 MPa
Modified surface shallexhibit adequate rotatingbeam fatigue strength.	The rotating beam fatiguestrength will exceed 10million cycles.	10 million cycles achieved witha strength of 206.7 MPa
Modified surface shall notexhibit excessive abrasion.	N/A	200N load:Avg. mass loss 0.006 gAvg. thickness loss 6%1500N load:Avg. Mass loss 0.179 gAvg. thickness loss 23%

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three wavy lines below it.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Consensus Orthopedics, Inc. % Mr. Matthew M. Hull. RAC 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762

JAN 2 6 2011

Re: K102927

Trade/Device Name: Consensus® Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prothesis Regulatory Class: Class II Product Code: MBH, JWH Dated: January 18, 2011 Received: January 20, 2011

Dear Mr. Hull:

. . .

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

. . . .

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Page 2 - Mr. Matthew M. Hull, RAC

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K 102927

Device Name; Consensus® Knee System

Indications for Use:

The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
D. The porous coated (CoCr beads with Titanium) femoral and tibial components may be used with or without cement.

X Prescription Use (21 CFR Part 801 Subpart D) AND/OR

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M.Mdkurm

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102927

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.