(65 days)
No
The document describes a mechanical knee implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.
No.
The Consensus Knee System is a medical device designed for primary knee replacement in cases of arthritis, failed osteotomy, or replacement of unsatisfactory components. It is used to restore function to a damaged knee joint, which falls under the definition of a therapeutic device. However, the FDA defines a therapeutic device as a device that treats or prevents a disease. While a knee replacement helps alleviate symptoms and improve mobility, it is a structural replacement, not a treatment in the sense of addressing the underlying disease process or preventing its progression.
No
The device is a knee replacement system, which is a therapeutic device designed to replace damaged or diseased knee joints. It is not used to diagnose a condition.
No
The device description clearly details physical components made of materials like CoCrMo and UHMWPE, indicating it is a hardware-based medical device (a knee implant system).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this is a knee implant system designed for surgical implantation to replace damaged knee joints. It is a physical device used in the body, not a test performed on samples from the body.
- Lack of Diagnostic Function: The intended use and device description focus on the surgical replacement of a joint and the materials and design of the implant. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, the CONSENSUS® KNEE SYSTEM Primary Knee 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.
The indications for use are:
- 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.
Product codes
JWH, OIY
Device Description
The Consensus Knee System (CKS) modular tibial baseplate is a non-porous (uncoated), anatomic, fixed-bearing design made from cast CoCrMo (ASTM F75). Its boss-and-fin type keel employs a modular 12/14 female taper for assembly with Consensus Revision Knee System (RKS) stems or the RKS taper plug. The CKS modular baseplate is offered in pegged, pegless, and holed configurations. Holed configurations are supplied with preassembled cement dams manufactured from UHMWPE (ASTM F648). All configurations are supplied with a distal plug intended for assembly in the operating room when stems are not desired. Distal plugs are manufactured from UHMWPE (ASTM F648). Other components compatible with the CKS modular baseplate include all CKS tibial inserts, femoral components, and patella components; all RKS femoral components; and the 6.5mm cancellous bone screw used with CKS holed baseplates.
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
Bench testing was carried out on the CKS modular baseplate and distal plug to verify their safety and effectiveness for clinical use. The baseplate tray region was tested per ASTM F1800-12 to ensure the tray would not fail under fatigue when fully supported by its lateral compartment. The keel and its taper connection were tested per ASTM F1800-12 to verify that the keel would not fail under fatigue when fully supported by an intramedullary stem. The distal plug was tested to ensure that it would resist involuntary dislocation from the keel and to ensure that it could be manually inserted and extracted in the operating room using available instrumentation.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2015
Consensus Orthopedics, Incorporated Mr. Matthew M. Hull Senior Director, QS & RA 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762
Re: K143725
Trade/Device Name: Consensus Knee System Modular Tibial Baseplate 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, OIY Dated: January 6, 2015 Received: January 7, 2015
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
1
(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 (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.
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" (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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -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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1. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K143725
Device Name: Consensus Knee System Modular Tibial Baseplate
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.
The indications for use are:
- 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.
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)
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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: | 23 December 2014 |
| Trade Name: | Consensus Knee System Modular Tibial Baseplate |
| Common Name: | Modular Tibial Baseplate |
| 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) |
Device Description:
The Consensus Knee System (CKS) modular tibial baseplate is a non-porous (uncoated), anatomic, fixed-bearing design made from cast CoCrMo (ASTM F75). Its boss-and-fin type keel employs a modular 12/14 female taper for assembly with Consensus Revision Knee System (RKS) stems or the RKS taper plug. The CKS modular baseplate is offered in pegged, pegless, and holed configurations. Holed configurations are supplied with preassembled cement dams manufactured from UHMWPE (ASTM F648). All configurations are supplied with a distal plug intended for assembly in the operating room when stems are not desired. Distal plugs are manufactured from UHMWPE (ASTM F648). Other components compatible with the CKS modular baseplate include all CKS tibial inserts, femoral components, and patella components; all RKS femoral components; and the 6.5mm cancellous bone screw used with CKS holed baseplates.
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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.
The indications for use are:
- 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.
Substantial Equivalence:
Technological Characteristics/ Substantial Equivalence:
The CKS modular baseplate is substantially equivalent to the CKS uncoated CoCr baseplate (K945589, K001456; K110950), the Consensus RKS CoCr baseplate (K100542), and the Natural-Knee II cemented modular baseplate (K023528) regarding its indications for use, technology, and performance. The distal plug used with the CKS modular baseplate, is substantially equivalent to the taper plug used with the NexGen stemmed tibial baseplate (K933785). As with the CKS modular baseplate, all predicate baseplate components are intended for cemented use.
Non-Clinical Performance Data:
Bench testing was carried out on the CKS modular baseplate and distal plug to verify their safety and effectiveness for clinical use. The baseplate tray region was tested per ASTM F1800-12 to ensure the tray would not fail under fatigue when fully supported by its lateral compartment. The keel and its taper connection were tested per ASTM F1800-12 to verify that the keel would not fail under fatigue when fully supported by an intramedullary stem. The distal plug was tested to ensure that it would resist involuntary dislocation from the keel and to ensure that it could be manually inserted and extracted in the operating room using available instrumentation.