· 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.

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.

AI/ML Overview

Acceptance Criteria and Study Proving Device Meets Criteria: MOBIO Total Knee System (K210483)

Based on the provided FDA 510(k) summary, the device in question is a Total Knee System, not an AI/software medical device. Therefore, the traditional acceptance criteria and study design for AI/software (e.g., MRMC studies, ground truth establishment for images, training/test sets) do not apply to this submission.

The FDA 510(k) process for a physical medical device like a knee replacement focuses on substantial equivalence to a previously cleared predicate device. This is demonstrated through a comparison of technological characteristics and performance data from non-clinical studies (bench testing) rather than clinical studies with human subjects or AI model validation.

Here's a breakdown of the acceptance criteria and study information as it pertains to this orthopedic implant:

1. Table of Acceptance Criteria and Reported Device Performance

For an orthopedic implant seeking 510(k) clearance, the "acceptance criteria" are generally met by demonstrating that the new device's performance is equivalent to, or better than, the predicate device across relevant performance metrics. These metrics are often derived from recognized consensus standards and ensure the device is safe and effective for its intended use.

Acceptance Criterion (Performance Metric)	Reported Device Performance (as demonstrated by Non-Clinical Studies)
Locking Mechanism Strength (Ensuring secure assembly of components)	Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence)
Range of Constraint (Characterizing the implant's biomechanical behavior)	Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence)
Contact Area and Contact Stress (Evaluating wear and load distribution characteristics of articulating surfaces)	Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence)
Tibiofemoral Range of Motion (Assessing the functional movement range of the implant)	Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence)
Characterization of UHMWPE Insert Material (Verifying the material properties of the tibial insert)	Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence)
Bacterial Endotoxin Testing (Ensuring sterility and absence of harmful endotoxins for single-use, sterile devices)	Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence)
Shelf Life Studies (Determining the stability and integrity of the device over its storage period)	Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence)
Biocompatibility (Confirming that the device materials are not harmful to biological tissue)	Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence)
Substantial Equivalence to Predicate Device (Overall design features, materials, manufacturing, sterilization methods)	Established; differences do not raise new questions of safety/effectiveness.

Note: The FDA 510(k) summary typically lists the types of studies performed, but the detailed results and specific numerical acceptance thresholds are part of the full submission, not the public summary. The "Reported Device Performance" here refers to the fact that supporting data was submitted and found acceptable by the FDA to demonstrate equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of human "test sets" as this is a non-clinical (bench) study for a physical device. The "sample size" would refer to the number of devices or components tested for each specific non-clinical study (e.g., how many locking mechanisms were tested for strength). This specific number is not provided in the 510(k) summary.
Data Provenance: The data is generated from bench testing in a laboratory setting, not from human subjects or clinical data in a specific country. The studies are typically conducted by the manufacturer or a contract research organization following recognized standards (e.g., ISO, ASTM).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This concept is not applicable to a physical medical device bench study. "Ground truth" in this context is established by:

Engineering specifications and design requirements.
International and national consensus standards (e.g., ISO 21536 for Knee joint prostheses, ASTM standards for material testing).
Validated test methods and equipment.

The "experts" involved would be qualified engineers, material scientists, and biomechanical experts who design the device, perform the tests, and interpret the data against established engineering principles and standards. Their qualifications are inherent in their professional roles and adherence to Good Manufacturing Practices (GMP) and quality system regulations (21 CFR 820).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for consensus in subjective human assessments, often in image interpretation. For a physical device, testing involves objective measurements (e.g., force, stress, range of motion) performed according to validated protocols, not subjective interpretation. Any outliers or discrepancies in test results would be investigated through root cause analysis, not adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. MRMC studies are used to assess the impact of AI algorithms on human reader performance, typically in diagnostic imaging. This 510(k) is for a physical orthopedic implant. Clinical studies, if performed, would typically be for PMA (Premarket Approval) applications or for higher-risk devices, not typically for 510(k) clearances that rely on substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is for a physical knee implant, not a software algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for performance is defined by:

Engineering Specifications: The design parameters and expected performance characteristics set by the manufacturer.
Consensus Standards: Performance criteria defined by recognized standards organizations (e.g., ISO, ASTM) for mechanical properties, material properties, wear, and biocompatibility of orthopedic implants.
Predicate Device Performance: The demonstrated safe and effective performance of the legally marketed predicate device (MOBIO Total Knee System; K202429, and reference devices K063423, K071071, K180446). The new device must meet or exceed these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train an AI algorithm. For a physical device, the equivalent would be the R&D and design verification process, where prototypes are developed and tested, and design iterations are guided by engineering principles and previous test results. There isn't a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As explained above, "ground truth" for a physical device is established through engineering design, recognized standards, and performance of predicate devices. There is no AI model "training" in this context.

Summary

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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

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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

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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)

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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):	RegulationNumber
	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal Polymer kneejoint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis	888.3560
Legally MarketedPredicate Devices to WhichSubstantial Equivalence isClaimed:	MOBIO Total Knee System; K202429
Legally Marketed ReferenceDevices Used to SupportSubstantial Equivalence:	Stryker Triathlon CS Lipped Insert, K063423Smith + Nephew LEGION Deep DishedInserts, K071071; MOBIO Total Knee System;K180446

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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:

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

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. 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.

Regulation Number and Section

§ 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.