(56 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 suggest the use of AI or ML.
Yes
The device description states, "The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function." This clearly indicates a therapeutic purpose.
No
The device description clearly states "The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function," indicating it is a therapeutic or treatment 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 tray, tibial inserts, patellar button, and surgical instruments, all made from materials like titanium alloy. This indicates it is a hardware device, not software-only.
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 b-ONE™ MOBIO™ Total Knee System is a modular artificial knee replacement system. It is a physical implant designed to replace a diseased joint.
- Intended Use: The intended use is for total knee arthroplasty, which is a surgical procedure to replace the knee joint. This is an in-vivo (within the living body) procedure, not an in-vitro (in glass/outside the body) test.
The device is a surgical implant, not a diagnostic test performed on samples.
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 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
Device Description
The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial tray, 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 Stemmed Baseplate with modular Stem Extension options. 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 b-ONE MOBIO Total Knee System Stemmed Tibial Baseplates are manufactured from forged titanium alloy. The baseplates are offered in 9 sizes with medial lateral dimensional range from 58-85mm and anterior posterior dimensional range from 58-85mm and anterior posterior dimensional range from 38-59mm. The baseplate is intended for cemented fixation. The Stemmed Baseplates mate with stem extensions through a threaded junction. The Tibial Stems are manufactured from forged titanium alloy. The Tibial Stems are offered in 3 diameters (12, 14, and 16mm) with various lengths ranging from 20-120mm. The stems are intended for cemented fixation.
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
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:
- Tibial Baseplate Fatigue
- Torque Testing
- Locking Mechanism Strength
- Constraint
- Contact Area and Contact Stress
- Tibiofemoral Range of Motion
- Bacterial Endotoxin Testing
- Shelf Life Studies
- Biocompatibility
Key Results: The information provided above supports that the MOBIO Total Knee System Stemmed Baseplate and Stem Extension components are 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 Stemmed Baseplate and Stem Extensions are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
b-ONE MOBIO PS Tibial Baseplate; K180446
Reference Device(s)
Stryker Triathlon T/S Universal Baseplate and Cemented Stems; K070095, DePuy Attune Cemented Stems: K160700
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
October 6, 2022
b-ONE ORTHO, Corp. Allison Gecik Director, US OA & RA 3 Wing Drive Suite #259 Cedar Knolls, New Jersey 07927
Re: K222431
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: August 11, 2022 Received: August 11, 2022
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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, Ph.D. 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
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Indications for Use
510(k) Number (if known) K222431
Device Name 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 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) | ☐ |
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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: | 973-965-8940 | |
| Date Prepared: | August 11, 2022 | |
| 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: | b-ONE MOBIO PS Tibial Baseplate; K180446 | |
| Legally Marketed Reference | ||
| Devices Used to Support | ||
| Substantial Equivalence: | Stryker Triathlon T/S Universal Baseplate | |
| and Cemented Stems; K070095 | ||
| DePuy Attune Cemented Stems: K160700 |
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Intended 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 tray, 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 Stemmed Baseplate with modular Stem Extension options. 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 b-ONE MOBIO Total Knee System Stemmed Tibial Baseplates are manufactured from forged titanium alloy. The baseplates are offered in 9 sizes with medial lateral dimensional range from 58-85mm and anterior posterior dimensional range from 58-85mm and anterior posterior dimensional range from 38-59mm. The baseplate is intended for cemented fixation. The Stemmed Baseplates mate with stem extensions through a threaded junction. The Tibial Stems are manufactured from forged titanium alloy. The Tibial Stems are offered in 3 diameters (12, 14, and 16mm) with various lengths ranging from 20-120mm. The stems are intended for cemented fixation.
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
- Sterilization methods
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Studies
- Tibial Baseplate Fatigue
- Torque Testing ●
- Locking Mechanism Strength ●
- Constraint ●
- Contact Area and Contact Stress ●
- Tibiofemoral Range of Motion
- Bacterial Endotoxin Testing
- Shelf Life Studies
- . Biocompatibility
Conclusion
The information provided above supports that the MOBIO Total Knee System Stemmed Baseplate and Stem Extension components are 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 Stemmed Baseplate and Stem Extensions are substantially equivalent to the predicate devices.