(120 days)
Not Found
No
The summary describes a mechanical implant system for knee arthroplasty and revision procedures. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies are mechanical tests, not related to data analysis or image processing.
Yes.
This device is designed for total knee arthroplasty procedures to address various conditions affecting the knee joint, such as osteoarthritis, rheumatoid arthritis, and deformities, and is also used in revision procedures. This demonstrates its therapeutic intent to treat or alleviate these medical conditions.
No
Explanation: The device description and intended use clearly state that this is a system for total knee arthroplasty procedures and revision knee surgery. It is an implantable medical device designed to replace or support anatomical structures, not to identify or assess a medical condition.
No
The device description explicitly details physical implants (femoral and tibial sleeves, tapered junction box, locking bolt, tibial tray) made of materials intended for surgical implantation. The performance studies also focus on mechanical testing of these physical 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is a system of implants (femoral and tibial sleeves, etc.) intended for use within the human body during total knee arthroplasty procedures. It is a surgical implant, not a device that analyzes samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic testing, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These devices are intended for use in total knee arthroplasty procedures for the following conditions:
- Loss of joint configuration and joint function.
- Osteoarthritis of the knee joint.
- Rheumatoid arthritis of the knee joint.
- Post-traumatic arthritis of the knee joint.
- Valgus, varus, or flexion deformities of the knee joint.
- Revision procedures where other treatments or devices have failed.
The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.
The BKS Revision is indicated for cemented application only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented biological fixation application.
Product codes
JWH, MBH
Device Description
The BKS® Revision Sleeves System expands the capabilities of the Balanced Knee® System (BKS®) Revision through the introduction of femoral and tibial sleeves, a tapered junction box, locking bolt, and a sleeve specific tibial tray. All new implants are a single-use modular system used in revision knee surgery to accommodate metaphyseal bone defects and provide rotational stability. The system is designed for cemented or uncemented fixation with the bone. The porous-coated femoral sleeve is affixed to the modular femoral component via a tapered junction box. The porous-coated tibial sleeve is affixed to a sleeve tibial tray.
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
The following non-clinical tests were conducted on the worst-case configurations of the BKS Revision Sleeves System and successfully met the predetermined acceptance criteria:
- Static Disassembly per ASTM F-1814 and ASTM F-2083
- Cyclic fatigue per ASTM F1800, ASTM F1814, and ASTM F2083 0
- Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72:2011
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
K031201, K060569, K103837, K160700, K140883
Reference Device(s)
Not Found
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
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Ortho Development Corporation Dan Petersen Regulatory Affairs Specialist 12187 So. Business Park Drive Draper, Utah 84020
Re: K181569 Trade/Device Name: BKS Revision Sleeves System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: June 13, 2018 Received: September 13, 2018
10/12/2018
Dear Dan Petersen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel S. Ramsey -S 2018.10.12 11:12:21 -04'00'
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181569
Device Name BKS Revision Sleeves System
Indications for Use (Describe)
These devices are intended for use in total knee arthroplasty procedures for the following conditions:
-
- Loss of joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
-
- Rheumatoid arthritis of the knee joint.
-
- Post-traumatic arthritis of the knee joint.
-
- Valgus, varus, or flexion deformities of the knee joint.
-
- Revision procedures where other treatments or devices have failed.
The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.
The BKS Revision is indicated for cemented application only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented biological fixation application.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
12187 So. Business Park Drive Draper, Utah 84020 801-553-9991/ fax 553-9993 Orthodevelopment.com
Image /page/3/Picture/2 description: The image shows the logo for "Ortho Development". The logo consists of a stylized purple circle with three gray arcs emanating from the left side, followed by the word "ORTHO" in purple, block letters. Below the word "ORTHO" is the word "DEVELOPMENT" in a smaller, less bold font.
Section 5 510(k) Summary
| Name of Sponsor: | Ortho Development Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
|------------------------------|------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Dan Petersen
Regulatory Affairs Specialist
Telephone: (801) 619-3416
Email: RA@OrthoDevelopment.com |
| Date Prepared: | August 8, 2018 |
| Submission Type: | Traditional 510(k) |
| Proprietary Name: | BKS® Revision Sleeves System |
| Common Name: | Knee Joint Replacement Prosthesis |
| Classification: | 21 CFR 888.3560: Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented prosthesis |
| | 21 CFR 888.3565: Knee joint patellofemorotibial metal/polymer
porous-coated uncemented prosthesis |
| Device Class: | Class II device |
| Device Product Code: | JWH, MBH |
| Primary Predicate Device: | BKS® Revision Knee System; Ortho Development (K031201, K060569,
K103837) |
| Additional Predicate Device: | ATTUNE® Revision Knee System; DePuy (K160700)
Vanguard® 360 OsseoTi™ Tibial Sleeve Augments, Biomet (K140883) |
5.1 Device Description
The BKS® Revision Sleeves System expands the capabilities of the Balanced Knee® System (BKS®) Revision through the introduction of femoral and tibial sleeves, a tapered junction box, locking bolt, and a sleeve specific tibial tray. All new implants are a single-use modular system used in revision knee surgery to accommodate metaphyseal bone defects and provide rotational stability. The system is designed for cemented or uncemented fixation with the bone. The porous-coated femoral sleeve is affixed to the modular femoral component via a tapered junction box. The porous-coated tibial sleeve is affixed to a sleeve tibial tray.
4
5.2 Indications for Use
These devices are intended for use in total knee arthroplasty procedures for the following conditions:
-
- Loss of joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
-
- Rheumatoid arthritis of the knee joint.
-
- Post-traumatic arthritis of the knee joint.
-
- Valgus, varus, or flexion deformities of the knee joint.
-
- Revision procedures where other treatments or devices have failed.
The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.
The BKS Revision is indicated for cemented application only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented biological fixation application.
5.3 Basis for Substantial Equivalence:
The BKS Revision Sleeves System has the same technological characteristics as the predicates. These include:
- Indications for use
- Intended use
- Basic design
- Function
- Manufacturer
- Manufacturing Process
- Packaging
- . Sterilization
The following non-clinical tests were conducted on the worst-case configurations of the BKS Revision Sleeves System and successfully met the predetermined acceptance criteria:
- Static Disassembly per ASTM F-1814 and ASTM F-2083
- Cyclic fatigue per ASTM F1800, ASTM F1814, and ASTM F2083 0
- Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72:2011
The fundamental scientific technology of the BKS Revision Sleeves System is the previously cleared predicates. The test results demonstrate that the BKS Revision Sleeves System is as safe, as effective, and performs as well as or better than the legally marketed predicates. No clinical studies were performed.
Based on similarities in intended use, design, manufacturing methods, sterilization, packaging, and the mechanical test results, the BKS Revision Sleeves System is substantially equivalent to the previously cleared predicates.