(60 days)
No
The summary describes a mechanical knee replacement system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "a modular artificial knee replacement system" with a stated "therapeutic effect" of replacing the diseased joint to restore function. This indicates a direct medical intervention to treat a condition.
No
The device is a knee replacement system used for total knee arthroplasty, which is a therapeutic intervention, 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. It is a hardware device intended for surgical implantation.
Based on the provided information, the MOBIO Total Knee System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a diseased knee joint. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device description details the components of an artificial knee replacement system, including femoral components, tibial trays, inserts, and a patellar button. These are all physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. The MOBIO Total Knee System is a surgical implant used in vivo to restore joint function.
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; OIY
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. The purpose of this submission is to introduce a line extension to the b-ONE™ MOBIO™ Total Knee System CR/CR PLUS Tibial Insert components and PS/PS PLUS Tibial Insert Components. Compatibility with the b-ONE™ MOBIO™ Total Knee System tibial baseplate and femoral components remains the same. There is no allowed interchangeability with systems manufactured by other companies.
The subject b-ONE™ MOBIO™ Tibial Inserts are made from UHMWPE GUR® 1020-E Crosslinked with .1% tocopherol and conventional UHMWPE GUR® 1020. This material is the same as that used in the reference and predicate devices. The pre-assembled locking wire is the same locking wire used in the existing Tibial Inserts and is manufactured from Cobalt Chrome conforming to ASTM F90.
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
- 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
- Wear Testing
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.
b-ONE MOBIO Total Knee System CR Tibial Insert (K202429); b-ONE MOBIO Total Knee System CR PLUS Tibial Insert (K210483)
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.
b-ONE MOBIO Total Knee System PS/PS+ Tibial Insert Components (K183025; 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
Image /page/0/Picture/0 description: The image shows the date January 21, 2022. The text is written in a clear, sans-serif font. The date is written in the standard US format, with the month first, followed by the day and year.
b-ONE ORTHO, Corp. Allison Gecik Associate Director, Regulatory Affairs 3 Wing Drive Suite #259 Cedar Knolls, New Jersey 07927
Re: K213673
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. OIY Dated: November 19, 2021 Received: November 22, 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
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., R.A.C. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K213673
Device Name MOBIO Total Knee System
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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: | 973-965-8940 | |
| Date Prepared: | November 10, 2021 | |
| Proprietary Name: | 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. | ||
| Knee joint patellofemorotibial polymer/metal/polymer | ||
| semi-constrained cemented prosthesis | 888.3560 | |
| Prosthesis, knee, patellofemorotibial, semi-constrained, | ||
| cemented, polymer + additive/metal/polymer + | ||
| additive. | ||
| Knee joint patellofemorotibial polymer/metal/polymer | ||
| semi-constrained cemented prosthesis. | ||
| Legally Marketed Predicate | ||
| Devices to Which Substantial | ||
| Equivalence is Claimed: | b-ONE MOBIO Total Knee System CR Tibial Insert (K202429); | |
| b-ONE MOBIO Total Knee System CR PLUS Tibial Insert (K210483) | ||
| Legally Marketed Reference | ||
| Devices Used to Support | b-ONE MOBIO Total Knee System PS/PS+ Tibial | |
| Insert Components (K183025; K180446) |
4
Substantial Equivalence:
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
- 0 Severe anteroposterior instability of the knee ioint
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. The purpose of this submission is to introduce a line extension to the b-ONE™ MOBIO™ Total Knee System CR/CR PLUS Tibial Insert components and PS/PS PLUS Tibial Insert Components. Compatibility with the b-ONE™ MOBIO™ Total Knee System tibial baseplate and femoral components remains the same. There is no allowed interchangeability with systems manufactured by other companies.
The subject b-ONE™ MOBIO™ Tibial Inserts are made from UHMWPE GUR® 1020-E Crosslinked with .1% tocopherol and conventional UHMWPE GUR® 1020. This material is the same as that used in the reference and predicate devices. The pre-assembled locking wire is the same locking wire used in the existing Tibial Inserts and is manufactured from Cobalt Chrome conforming to ASTM F90.
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
5
- Manufacturing processes ●
- 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.
- o 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 ●
- Wear Testing .
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. The subject and predicate devices only differ in material. 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.