(61 days)
No
The document describes a mechanical knee replacement system and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies listed are mechanical and material tests.
Yes
The device is described as "a modular artificial knee replacement system" and its "therapeutic effect is replacement of the diseased joint with artificial components to restore joint function." This clearly indicates it is a therapeutic device designed to treat a medical condition.
No
This device is a total knee replacement system (prosthetic device) intended to restore joint function, not to identify or diagnose a disease or condition. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is a "modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial trav, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments." These are all physical hardware components.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The MOBIO Total Knee System is a surgical implant designed to replace a diseased knee joint. It is comprised of physical components (femoral components, tibial tray, tibial inserts, patellar button) that are surgically implanted into the patient's body.
- Intended Use: The intended use is to treat painful and disabling knee conditions by replacing the joint, not by analyzing samples from the body.
The device is a Class II or Class III medical device (depending on the specific components and regulatory classification) used in a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The 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 the PS and PS+:
- Ligamentous instability requiring implant bearing surface geometries with increased ● constraint
- Absent or nonfunctioning posterior cruciate ligament .
- Severe anteroposterior instability of the knee joint
The MOBIO Total Knee System is intended for implantation with bone cement only. MOBIO Total Knee System components are not intended for use with other knee systems.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial trav, 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. This submission is to add a condylar stabilizing (CR+) Tibial Insert device type to the system. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies.
The CR PLUS Tibial Inserts are offered in a total of 50 sizes, size A/1-3 through HJ/8-10, with 10 thicknesses ranging from 9 to 25mm. The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies:
- Locking Mechanism Strength
- Range of Constraint
- Contact Area and Contact Stress
- Tibiofemoral Range of Motion
- Characterization of UHMWPE Insert Material
- Bacterial Endotoxin Testing
- Shelf Life Studies
- Biocompatibility
Key results: The information provided above supports that the MOBIO Total Knee System is as safe and effective as the predicate devices with the same intended use. Some minor differences in design and technology exist between the subject and predicate devices, however applicable reference devices have been cited to support the conclusion that these differences do not raise any new questions of safety and effectiveness. The MOBIO Total Knee System is substantially equivalent to the predicate devices.
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.
MOBIO Total Knee System; K202429
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.
Stryker Triathlon CS Lipped Insert, K063423, Smith + Nephew LEGION Deep Dished Inserts, K071071, MOBIO Total Knee System, K180446
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
April 21, 2021
Image /page/0/Picture/1 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 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.
b-ONE ORTHO, Corp. Allison Gecik Regulatory Affairs Associate Director 3 Wing Drive Suite # 259 Cedar Knolls, New Jersey 07927
Re: K210483
Trade/Device Name: MOBIO Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: February 17, 2021 Received: February 19, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song. PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K210483
Device Name MOBIO Total Knee System
Indications for Use (Describe)
The 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 standard fracture- management techniques
Additional Indications for the Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+):
- · Ligamentous instability requiring implant bearing surface geometries with increased constraint
- · Absent or nonfunctioning posterior cruciate ligament
- · Severe anteroposterior instability of the knee joint
The MOBIO Total Knee System is intended for implantation with bone cement only. 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K210483
Page 1
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 | |
| agecik@b1.co | ||
| Telephone: | 973-587-8431 | |
| Date Prepared: | August 21, 2020 | |
| Proprietary Name: | MOBIO Total Knee System | |
| Classification: | Class II | |
| Classification Panel: | Orthopedic | |
| Common Name: | Total Knee Joint Replacement | |
| Product Code(s): | JWH | |
| Classification Name(s): | Regulation | |
| Number | ||
| Prosthesis, Knee, Patellofemorotibial, Semi- | ||
| Constrained, Cemented, Polymer/Metal Polymer knee | ||
| joint patellofemorotibial polymer/metal/polymer semi- | ||
| constrained cemented prosthesis | 888.3560 | |
| Legally Marketed | ||
| Predicate Devices to Which | ||
| Substantial Equivalence is | ||
| Claimed: | MOBIO Total Knee System; K202429 | |
| Legally Marketed Reference | ||
| Devices Used to Support | ||
| Substantial Equivalence: | Stryker Triathlon CS Lipped Insert, K063423 | |
| Smith + Nephew LEGION Deep Dished | ||
| Inserts, K071071; MOBIO Total Knee System; | ||
| K180446 |
4
Indications for Use:
The 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 the PS and PS+:
- Ligamentous instability requiring implant bearing surface geometries with increased ● constraint
- Absent or nonfunctioning posterior cruciate ligament .
- Severe anteroposterior instability of the knee joint
The MOBIO Total Knee System is intended for implantation with bone cement only. MOBIO Total Knee System components are not intended for use with other knee systems.
Device Description/Technological Characteristics:
The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial trav, 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. This submission is to add a condylar stabilizing (CR+) Tibial Insert device type to the system. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies.
The CR PLUS Tibial Inserts are offered in a total of 50 sizes, size A/1-3 through HJ/8-10, with 10 thicknesses ranging from 9 to 25mm. The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy.
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 MOBIO Total Knee System and the predicate devices share the following characteristics:
- . Materials of construction
- . Manufacturing processes
5
- . Sizes offered
- . Product design for shape and macrostructures- only differences to the predicate are dimensions specific to the condylar stabilizing features of the subject devices.
- . Sterilization methods
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Studies
- Locking Mechanism Strength .
- . Range of Constraint
- Contact Area and Contact Stress .
- Tibiofemoral Range of Motion .
- Characterization of UHMWPE Insert Material .
- . Bacterial Endotoxin Testing
- Shelf Life Studies
- Biocompatibility .
Conclusion
The information provided above supports that the MOBIO Total Knee System is as safe and effective as the predicate devices with the same intended use. Some minor differences in design and technology exist between the subject and predicate devices, however applicable reference devices have been cited to support the conclusion that these differences do not raise any new questions of safety and effectiveness. The MOBIO Total Knee System is substantially equivalent to the predicate devices.