(203 days)
No
The document describes a knee implant system and its components, focusing on material composition and mechanical properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, a knee implant component, directly treats conditions like arthritis and failed joint replacements by replacing or assisting a damaged biological structure.
No
The device, a tibial insert for knee replacement systems, is designed for therapeutic purposes (primary intervention, replacement of failed components) and does not gather or interpret data about a patient's condition to make a diagnosis.
No
The device description clearly describes a physical implant (tibial insert and patellae) made of UHMWPE with a vitamin E additive, intended for use in knee replacement surgery. It is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a component of a knee replacement system used for surgical intervention in various knee conditions. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The device is described as a tibial insert and patella made of a specific material, designed to function as a gliding surface within a knee implant. This is a physical component for implantation, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is used within the knee joint itself, not for analyzing samples taken from the body.
Therefore, the device described is a medical device (specifically, an implantable orthopedic device), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used with the components of the Consensus Knee System:
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 non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
- E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.
When used as a component of the Consensus Revision Knee System:
The Consensus® Revision Knee System is designed as a system and is only intended to be used with compatible components of the Consensus® Knee System. The revision knee femoral and tibial components are intended for cemented use only.
The indications for use are:
- A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
- B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion. dvsfunction, or prior patellectomy)
- C. Failed osteotomy or unicompartmental replacements.
- D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
- E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery
- F. Moderate valgus, varus, or flexion deformities
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH, OIY
Device Description
The VitalitE Tibial Insert is a vitamin E version of the UHMWPE tibial insert that has been a component of both the Consensus Knee System (CKS) and the Consensus Revision Knee System (RKS). The new insert still serves as the gliding surface between the metallic femoral component and the metallic tibial base plate of these knee systems. The new VitalitE insert will also be available in a cruciate retaining (CR) or ultra-congruent/ PCL substituting designs in sizes 0 through 6 and in thicknesses from 10 to 22 mm. The proprietary locking mechanism design on the underside of the insert will remain unchanged. The only difference will be the vitamin E additive in the UHMWPE which is a-tocopherol. This is the exact same polymer that is used in the Consensus VitalitE Acetabular insert but with a slightly lower radiation dose. Consensus will also offer our current CKS all-poly patellae in the new vitamin E UHMWPE material. This includes both the round and oval configurations with either a 7.5 mm or 10 mm thickness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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 testing and analysis were provided, including bench testing, material characterization, and biocompatibility testing. Bench testing of the new insert material included wear testing of the worst case tibial insert, and anterior disassembly testing of the locking mechanism (push-out testing) on a range of various sizes and types of inserts.
All of the observed results indicate that the VitalitE Tibial Inserts and Patellas are substantially equivalent to devices currently marketed. Therefore, the devices are as safe, as effective, and perform at least as safely and effectively as legally marketed predicates.
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, K953443, K110950, K100542
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
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K133919 Page 1 of 3
2014
2. 510(k) SUMMARY
| Sponsor Name: | Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills, CA 95762 | JUL 1 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| 510(k) Contact: | Matthew M. Hull, RAC
Phone: (916) 355-7156/ Fax: (916) 355-7190
mhull@consensusortho.com | |
| Date Prepared: | 20 December 2013 | |
| Trade Name: | VitalitE Tibial Insert & Patellar Components | |
| Common Name: | Total Knee Arthroplasty System | |
| Classification Name: | Knee joint patellofemorotibial Polymer/metal/polymer semi-
constrained cemented prosthesis is a Class 2 device per 21 CFR
888.3560 (Product Code JWH/OIY) | |
| | Knee joint patellofemorotibial metal/polymer porous-coated
uncemented prosthesis is a Class II device per 21 CFR
888.3565 (Product Code MBH) | |
Device Description:
The VitalitE Tibial Insert is a vitamin E version of the UHMWPE tibial insert that has been a component of both the Consensus Knee System (CKS) and the Consensus Revision Knee System (RKS). The new insert still serves as the gliding surface between the metallic femoral component and the metallic tibial base plate of these knee systems. The new VitalitE insert will also be available in a cruciate retaining (CR) or ultra-congruent/ PCL substituting designs in sizes 0 through 6 and in thicknesses from 10 to 22 mm. The proprietary locking mechanism design on the underside of the insert will remain unchanged. The only difference will be the vitamin E additive in the UHMWPE which is a-tocopherol. This is the exact same polymer that is used in the Consensus VitalitE Acetabular insert but with a slightly lower radiation dose. Consensus will also offer our current CKS all-poly patellae in the new vitamin E UHMWPE material. This includes both the round and oval configurations with either a 7.5 mm or 10 mm thickness.
1
Indications for Use:
When used with the components of the Consensus Knee System:
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 non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
- E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.
When used as a component of the Consensus Revision Knee System:
The Consensus® Revision Knee System is designed as a system and is only intended to be used with compatible components of the Consensus® Knee System. The revision knee femoral and tibial components are intended for cemented use only.
The indications for use are:
- A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
- B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion. dvsfunction, or prior patellectomy)
- C. Failed osteotomy or unicompartmental replacements.
- D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
- E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery
- F. Moderate valgus, varus, or flexion deformities
Substantial Equivalence:
Technological Characteristics/ Substantial Equivalence:
The new VitalitE tibial insert is the exact same design as cleared for use with the Consensus Knee System in K932837, K953443 & K110950 and also with the Consensus Revision Knee in K 100542 and is compatible with all of the metallic femoral and tibial components from those systems. The UHMWPE (GUR 1020) with a-tocopherol is the same polymer as that cleared in K 130652 for the Consensus VitalitE Acetabular Insert with the exception of the slightly lower radiation dose. The use of Vitamin E infused UHMWPE tibial insert for knee systems has been cleared for use in DJO/ Encore systems via K091956 and K103223. The UHMWPE used in the current
2
K133919
Page 3 of 3
Consensus tibial inserts is GUR 1050. The VitalitE inserts are cleaned, packaged, and sterilized using the same validated processes as the current inserts and will also have a 5 year shelf-life.
Non-Clinical Performance Data:
Non-clinical testing and analysis were provided, including bench testing, material characterization, and biocompatibility testing. Bench testing of the new insert material included wear testing of the worst case tibial insert, and anterior disassembly testing of the locking mechanism (push-out testing) on a range of various sizes and types of inserts.
All of the observed results indicate that the VitalitE Tibial Inserts and Patellas are substantially equivalent to devices currently marketed. Therefore, the devices are as safe, as effective, and perform at least as safely and effectively as legally marketed predicates.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The image is a black and white picture of the address.
July 14, 2014
Consensus Orthopedics, Incorporated Mr. Matthew M. Hull QS & RA Director 1115 Windfield Way, Suite 100 El Dorado Hills. California 95762
Re: K133919
Trade/Device Name: VitalitE Tibial Inserts & Patellar Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OIY Dated: June 10, 2014 Received: June 12, 2014
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 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
4
Page 2 - Mr. Matthew M. Hull - .
(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 contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1. INDICATIONS FOR USE STATEMENT
510(k) Number: K133919
Device Name: VitalitE Tibial Inserts & Patellar Components
Indications for Use:
When used with the components of the Consensus Knee System:
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 theumatoid 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 non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
- E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.
When used as a component of the Consensus Revision Knee System:
The Consensus® Revision Knee System is designed as a system and is only intended to be used with compatible components of the Consensus® Knee System. The revision knee femoral and tibial components are intended for cemented use only.
The indications for use are:
- A. Primary intervention of rheumatoid arthritis, osteoarthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or B. prior patellectomy )
- C. Failed osteotomy or unicompartmental replacements.
- D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
- The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized u at the time of surgery
- Moderate valgus, varus, or flexion deformities F.
Prescription Use X (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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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