(88 days)
No
The document describes a traditional knee replacement system and does not mention any AI or ML components or functionalities.
Yes
The device description explicitly states, "The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function."
No
The b-ONE MOBIO Total Knee System is an artificial knee replacement system designed to restore joint function by replacing diseased joint components. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a modular artificial knee replacement system comprised of physical components like femoral components, tibial baseplate, tibial inserts, and a patellar resurfacing button. It also mentions reusable surgical instruments. This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the b-ONE MOBIO Total Knee System is for total knee arthroplasty, which is a surgical procedure to replace a diseased joint. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a modular artificial knee replacement system comprised of components like femoral components, tibial baseplates, tibial inserts, and a patellar button. These are all physical implants designed to replace anatomical structures.
- 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, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The b-ONE MOBIO Total Knee System is intended for total knee arthroplasty due to the following conditions:
Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis.
Post-traumatic loss of knee joint configuration and function.
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Revision of previous unsuccessful knee replacement or other procedure.
Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques.
Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components:
Ligamentous instability requiring implant bearing surface geometries with increased constraint.
Absent or nonfunctioning posterior cruciate ligament.
Severe anteroposterior instability of the knee joint.
The b-ONE MOBIO Total Knee System is intended for implantation with bone cement only. b-ONE MOBIO Total Knee System components are not intended for use with other knee systems.
Product codes
JWH, OIY
Device Description
The b-ONE™ MOBIO™ Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.
The purpose of this submission is to add a line extension to the existing system to offer the Tibial Inserts and Patella components in UHMWPE Crosslinked with 0.1% tocopherol.
All system components are supplied sterile and are single use devices.
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
Non-Clinical Studies:
Characterization of Vitamin E UHMWPE Insert Material
Wear Testing
Biocompatibility
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 28, 2019
b-One Ortho Corp. Allison Gecik Regulatory Affairs Manager 3 Wing Drive Suite #259 Cedar Knolls, New Jersey 07927
Re: K183025
Trade/Device Name: MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH, OIY Dated: January 17, 2019 Received: January 18, 2019
Dear Allison Gecik:
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,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is by Peter G. Allen -S. The date of the signature is 2019.01.28. The time of the signature is 13:46:53 -05'00'.
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K183025
Device Name b-ONE MOBIO Total Knee System
Indications for Use (Describe)
The b-ONE MOBIO Total Knee System is intended for total knee arthroplasty due to the following conditions:
· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis.
· Post-traumatic loss of knee joint configuration and function.
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.
· Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture- management techniques.
Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components:
· Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- · Absent or nonfunctioning posterior cruciate ligament.
· Severe anteroposterior instability of the knee joint.
The b-ONE MOBIO Total Knee System is intended for implantation with bone cement only. b-ONE MOBIO Total Knee System components are not intended for use with other knee systems.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K183025 Page 1/3
TRADITIONAL 510(K) SUMMARY As required by 21 CFR 807.92
Submitter Information:
| Submitter's Name: | b-ONE Ortho Corp. |
|---|---|
| Address: | 3 Wing Drive |
| Suite 259 | |
| Cedar Knolls, NJ 07927 | |
| Telephone: | 866-276-4538 |
| Contact Person: | Allison Gecik |
| Telephone: | 973-587-8431 |
| Date Prepared: | October 31, 2018 |
| Proprietary Name: | b-ONE™ MOBIO™ Total Knee System |
| Classification: | Class II |
| Classification Panel: | Orthopedic |
| Common Name: | Total Knee Joint Replacement |
| Product Code(s): | JWH, OIY |
| Classification Name(s): | |
| Regulation | |
| Number | |
| Prosthesis, Knee, Patellofemorotibial, semi-constrained | |
| cemented, Polymer/Metal/Polymer | |
| 888.3560 | |
| Prosthesis, knee, patellofemorotibial, semi-constrained, | |
| cemented, polymer + additive/metal/polymer + additive | |
| 888.3560 | |
| Legally Marketed | |
| Predicate Devices to Which | |
| Substantial Equivalence is | |
| Claimed: | b-ONE Total Knee System; K180446 |
| Legally Marketed Reference | |
| Devices Used to Support | |
| Substantial Equivalence: | Zimmer Persona The Personalized Knee System; |
| K121771 |
Intended Use:
The b-ONE™ MOBIO™ Total Knee System is intended for total knee arthroplasty due to the following conditions:
- Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint ● disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis.
4
K183025 Page 2/3
- Post-traumatic loss of knee joint configuration and function.
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability.
- . Revision of previous unsuccessful knee replacement or other procedure
- Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-● management techniques.
Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components:
- Ligamentous instability requiring implant bearing surface geometries with increased constraint. ●
- Absent or nonfunctioning posterior cruciate ligament. ●
- Severe anteroposterior instability of the knee joint
The b-ONE™ MOBIO™ Total Knee System is intended for implantation with bone cement only.
b-ONE™ MOBIO™ Total Knee System components are not intended for use with other knee
systems.
Device Description/Technological Characteristics:
The b-ONE™ MOBIO™ Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.
The purpose of this submission is to add a line extension to the existing system to offer the Tibial Inserts and Patella components in UHMWPE Crosslinked with 0.1% tocopherol.
All system components are supplied sterile and are single use devices.
Comparison of Technological Characteristics
The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The b-ONE™ MOBIO™ Total Knee System and the predicate devices share the following characteristics:
- Materials of construction
- Manufacturing processes
- Sizes offered ●
- Product design for shape and macrostructures
- Sterilization methods .
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K183025 Page 3/3
Performance Data
The following performance data were provided in support of the substantial equivalence determination. All performance testing performed for the predicate system was conducted on the subject material and therefore is applicable to the subject devices. Additional performance testing condiucted to support the Vitamin E UHMWPE material is listed below.
Non-Clinical Studies
- Characterization of Vitamin E UHMWPE Insert Material ●
- Wear Testing
- Biocompatibility ●
Conclusion
The information provided above supports that the b-ONE™ Total Knee System is as safe and effective as the predicate devices with the same intended use. Applicable reference devices have been cited to support the conclusion that the addition of new material does not raise any new questions of safety and effectiveness. The b-ONE™ MOBIO™ Total Knee System is substantially equivalent to the predicate devices.