(114 days)
No
The summary describes a traditional knee implant system and its mechanical properties, with no mention of AI or ML.
Yes
The device is a knee replacement system designed to restore knee function in patients with various forms of arthritis and failed previous surgeries, which are therapeutic interventions.
No
This device, the CONSENSUS® KNEE SYSTEM Primary Knee, is designed as a total knee replacement system. Its purpose is to replace failed knee components or address conditions like arthritis, not to diagnose a medical condition.
No
The device description explicitly states that the device incorporates femoral, tibial, and patellar components, which are physical hardware implants. The performance studies also focus on the mechanical properties of these physical components.
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 replacing knee joints due to various conditions like arthritis and failed previous surgeries. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details the physical components of a knee replacement system (femoral, tibial, patellar components) and associated instrumentation for implantation. This is consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
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)
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.
- Microstructure of the modified surface
- 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 of less than that measured in a legally marketed device.
- Acceptance Criteria: Equal to or improved corrosion resistance when compared with CoCr beads using ASTM F746 & G61
- Verification Results:
- Critical Potential CoCr Beads 1290 mV
- Breakdown Potential 1200 mV
- Ti Coated CoCr Beads 1315 mV
- 1200 mV
- Modified surface shall exhibit adequate static tensile strength
- Acceptance Criteria: The static tensile strength will exceed 20 MPa.
- Verification Results: Static Tensile Strength of 58.32 MPa
- Modified surface shall exhibit adequate static shear strength.
- Acceptance Criteria: The static shear strength will exceed 20 MPa.
- Verification Results: Static Shear Strength of 58.32 MPa
- Modified surface shall exhibit adequate shear fatigue strength.
- Acceptance Criteria: The shear fatigue strength will exceed 10 million cycles.
- Verification Results: 10 million cycles achieved with a strength of 13.78 MPa
- Modified surface shall exhibit adequate rotating beam fatigue strength.
- Acceptance Criteria: The rotating beam fatigue strength will exceed 10 million cycles.
- Verification Results: 10 million cycles achieved with a strength of 206.7 MPa
- Modified surface shall not exhibit excessive abrasion.
- Verification Results:
- 200N load: Avg. mass loss 0.006 g; Avg. thickness loss 6%
- 1500N load: Avg. Mass loss 0.179 g; Avg. thickness loss 23%
- Verification Results:
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.
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.
K051229, K030623, K033489, K073286, K070214
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
§ 888.3565 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.
0
Page 1 of 3
2. 510(k) SUMMARY
| Sponsor Name: | Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills, CA 95762 | JAN 2 6 2011 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 510(k) Contact: | Matthew M. Hull, RAC
Phone: (916) 355-7156/ Fax: (916) 355-7190
mhull@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 CFR
888.3560 (Product Code JWH) | |
| | Knee joint patellofemorotibial metal/polymer porous-coated
uncemented prosthesis is a Class II device per 21 CFR
888.3565 (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.
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
1
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 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 of 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 | |||
| Ti Coated | |||
| CoCr Beads 1315 mV | 1200 mV | ||
| Modified surface shall | |||
| exhibit adequate static | |||
| tensile strength | The static tensile strength | ||
| will exceed 20 MPa. | Static Tensile Strength of | ||
| 58.32 MPa |
2
.
| Modified surface shall
exhibit adequate static shear
strength. | The static shear strength
will exceed 20 MPa. | Static Shear Strength of
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% |
3
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
. . . .
4
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.
$\overline{A}$ vs. in
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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