(84 days)
No
The summary describes a traditional knee replacement system with mechanical components and instrumentation, with no mention of AI or ML technologies.
Yes
The device, the CONSENSUS® KNEE SYSTEM, is designed for primary intervention of various types of arthritis and replacement of unsatisfactory knee components to restore knee function, which directly addresses therapeutic purposes.
No
Explanation: The device is a total knee replacement system designed to restore knee function, not to identify or diagnose medical conditions.
No
The device description explicitly states it incorporates femoral, tibial, and patellar components, which are hardware. The performance studies also focus on the physical properties and performance of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the CONSENSUS® KNEE SYSTEM is a "primary fixed-bearing total knee system" consisting of "femoral, tibial, and patellar components and all associated instrumentation needed for implantation." These are physical implants used within the body during surgery.
- Intended Use: The intended uses listed are all related to surgical procedures for treating knee conditions (arthritis, failed replacements, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, laboratory procedures, or providing diagnostic information based on such analysis.
Therefore, the CONSENSUS® KNEE SYSTEM is a surgical implant, not an In Vitro Diagnostic device.
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) components may be used with or without cement.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
The Consensus Total Knee System (CKS) is a primary fixed-bearing total knee system that has been on the market since the mid-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.
The CKS metallic components are available in non-porous and porous coated variants for cemented use and in a porous coated (CoCr beads with Titanium) version for uncemented use.
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:
Porous Coating: CoCr beads with Ti coating (applicable for all CoCr implants)
- Microstructure of the modified surface
- Verification Results: 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 Breakdown Potential CoCr Beads 1290 mV 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%
RLP Femoral Components
- The articulating surface of the RLP components shall match that of their standard and PS counterparts.
- Acceptance Criteria: Similar contact area and surface stress distributions.
- Verification Results: RLP had the same contact area as the original CKS. The PS RLP matches the articulating surface of the RLP.
Size 0 Tibial Base Plate and Insert
- Size 0 tibial baseplate/insert assembly shall permit adequate push-in/push-out force.
- Acceptance Criteria: Similar push-in/push-out loads when compared with existing baseplate/insert combinations.
- Verification Results: Minimum push-out load was 428 lbs with failure mode being deformation of anterior snap recess in poly insert; Similar to other insert/baseplate combinations. Components can be easily inserted by hand.
Thicker Tibial Insert
- Insert thickness per FDA Guidance Jan. 16, 2003.
- Acceptance Criteria: Insert thickness must be >6mm.
- Verification Results: Insert thickness was greater than 6mm.
Porous Coated Metal Backed Patella
- The articulating surface of the porous coated metal backed patella shall match that of current patellas.
- Acceptance Criteria: Identical articulating surface.
- Verification Results: Articulating surface of the porous coated metal backed patella is identical to existing patella.
- The mating geometry between the UHMWPE and metal back of the porous coated metal backed patella shall match that of current metal backed patella.
- Acceptance Criteria: Identical mating geometry.
- Verification Results: The mating geometry of the porous coated metal backed patella is identical to the existing metal backed patella.
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.
K932837, K954818, K962215, K001456, K983004, K102927
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.
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
KI10950 Page 1 of 4
JUN 2 7 2011
2. 510(k) SUMMARY
| Sponsor Name: | Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills, CA 95762 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Matthew M. Hull, RAC
Phone: (916) 355-7156/ Fax: (916) 355-7190
mhull@consensusortho.com |
| Date Prepared: | 1 April 2011 |
| Trade Name: | Consensus® Knee System, Line Extensions |
| Common Name: | Total knee prosthesis for cemented or uncemented 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 the mid-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
1
the femur is designed to allow the load from the patella to be evenly distributed on the femur with adequate lateral constraint.
The CKS metallic components are available in non-porous and porous coated variants for cemented use and in a porous coated (CoCr beads with Titanium) version for uncemented 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) components may be used with or without cement.
Substantial Equivalence:
The CKS components were originally cleared by FDA in K932837* with a posterior stabilizing (PS) version cleared in K954818* & K962215*. The CKS was expanded in K001456** (femoral components) and K983004** (tibial components) and most recently cleared for uncemented use in K102927.
*These 510(k)'s were cleared prior to the purchase of U.S. Medical Products by Hayes Medical in 1996. **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.
This submission is to add the following line extensions to the Consensus Knee System:
-
- Reduced Lateral Profile (RLP) femoral component in standard and PS versions
-
- Porous coated PS femoral component
-
- Size 0 tibial baseplate and inserts
-
- 20 & 22 mm thick poly inserts
-
- Porous coated patella for uncemented use.
The CKS implants are also substantially equivalent to the Gender Solutions™ Natural Knee® Flex System by Zimmer, Inc. cleared in K073286 & K070214 with the above options.
2
Non-Clinical Performance Data:
| Porous Coating: CoCr beads with Ti coating (applicable for all CoCr implants) | ||
|---|---|---|
| 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 | Equal to or improved corrosion resistance when | Critical Potential Breakdown Potential |
| CoCr Beads 1290 mV 1200 mV | ||
| than that measured in a legally marketed device. | compared with CoCr beads using ASTM F746 & G61 | 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 |
| 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% |
| RLP Femoral Components | | |
| Specification | Acceptance Criteria | Verification Results |
| The articulating surface of the RLP components shall
match that of their standard and PS counterparts. | Similar contact area and surface stress distributions. | RLP had the same contact area as the original CKS. The PS
RLP matches the articulating surface of the RLP. |
| Size 0 Tibial Base Plate and Insert | | |
| Specification | Acceptance Criteria | Verification Results |
| Size 0 tibial baseplate/insert assembly shall permit
adequate push-in/push-out force. | Similar push-in/push-out loads when compared with existing baseplate/insert combinations. | Minimum push-out load was 428 lbs with failure mode being deformation of anterior snap recess in poly insert; Similar to other insert/baseplate. |
| | | combinations. Components
can be easily inserted by hand. |
| Thicker Tibial Insert | | |
| Specification | Acceptance Criteria | Verification Results |
| Insert thickness per FDA
Guidance Jan. 16, 2003. | Insert thickness must be
6mm. | Insert thickness was greater
than 6mm. |
| Porous Coated Metal Backed Patella | | |
| Specification | Acceptance Criteria | Verification Results |
| The articulating surface of the
porous coated metal backed
patella shall match that of
current patellas. | Identical articulating surface. | Articulating surface of the porous
coated metal backed patella is
identical to existing patella. |
| The mating geometry between
the UHMWPE and metal back
of the porous coated metal
backed patella shall match that
of current metal backed
patella. | Identical mating geometry. | The mating geometry of the
porous coated metal backed
patella is identical to the existing
metal backed patella. |
Below is a summary of the testing related to the various aspects of the CKS line extension.
3
:
·
.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Consensus Orthopedics, Inc. % Mr. Matthew Hull 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762
JUN 2 7 2011
Re: K110950
Trade/Device Name: Consensus® Knee System, Line Extensions Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH. JWH Dated: April 1, 2011 Received: April 4, 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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Mr. Matthew Hull
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/CDRHOffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erind Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
1. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
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) components may be used with or without cement.
Prescription Use ※ (21 CFR Part 801 Subpart D)
AND/OR
Over the Counter Use (21 CFR Part 801 Subpart C)
KI10950
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ar M. Melleron
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110950