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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the MOBIO Total Knee System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or reporting results from a study proving the device meets those criteria in the way one might expect for an AI algorithm or a diagnostic tool.

The "acceptance criteria" in this context refer to the requirements for demonstrating substantial equivalence for a new or modified medical device. The "study" proving the device meets these criteria is the collection of non-clinical tests and comparisons presented in the 510(k) submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't present a table with explicit "acceptance criteria" and "reported device performance" in the quantitative sense typical for a diagnostic or AI device. Instead, the acceptance criteria are implicitly met by demonstrating that the new device's performance, materials, and design are substantially equivalent to those of legally marketed predicate devices.

The "reported device performance" is essentially that the MOBIO Total Knee System is as safe and effective as the predicate devices based on the non-clinical tests performed.

Category	Acceptance Criteria (Implicit from Substantial Equivalence)	Reported Device Performance (Summary from Document)
Materials	Materials of construction are substantially equivalent to predicate devices.	Subject device uses forged titanium alloy for baseplates and stems, the same material class as commonly used in predicate knee systems.
Manufacturing	Manufacturing processes are substantially equivalent to predicate devices.	Standard manufacturing processes for medical implants are used, similar to predicate devices.
Sizes Offered	Sizes offered are comparable to predicate devices.	Tibial Baseplates offered in 9 sizes (medial-lateral: 58-85mm, anterior-posterior: 38-59mm). Tibial Stems offered in 3 diameters (12, 14, 16mm) with lengths from 20-120mm. These ranges are typical for total knee systems.
Product Design	Product design (shape, macrostructures) is substantially equivalent to predicate devices.	Design features are comparable to predicate devices, with minor differences not raising new safety/effectiveness questions. This submission focused on adding a Stemmed Baseplate with modular Stem Extension options to an existing cleared system.
Sterilization	Sterilization methods are substantially equivalent to predicate devices.	All system components are supplied sterile and are single-use devices, consistent with standard practice for surgically implanted devices.
Mechanical Performance	The device performs mechanically comparably to predicate devices for its intended use, as demonstrated by non-clinical tests.	Non-clinical studies included: Tibial Baseplate Fatigue, Torque Testing, Locking Mechanism Strength, Constraint, Contact Area and Contact Stress, Tibiofemoral Range of Motion. The results are implied to be acceptable as they support substantial equivalence.
Biocompatibility	The device materials are biocompatible, similar to predicate devices.	Biocompatibility testing was performed. The results are implied to be acceptable as they support substantial equivalence.
Shelf Life	The device maintains its safety and effectiveness over its stated shelf life.	Shelf Life Studies were performed. The results are implied to be acceptable as they support substantial equivalence.
Bacterial Endotoxin	The device is free from bacterial endotoxin within acceptable limits.	Bacterial Endotoxin Testing was performed. The results are implied to be acceptable as they support substantial equivalence.
Safety & Effectiveness	The device is as safe and effective as the legally marketed predicate devices. Differences in design/technology do not raise new safety/effectiveness questions.	"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."

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

For a medical implant like a total knee system, studies are typically non-clinical (bench testing, mechanical testing) rather than involving patient test data sets in the way an AI algorithm would.

Sample Size: Not explicitly stated in terms of "test set" size. The "samples" would be the individual components or assemblies tested for fatigue, torque, etc. The document does not specify the number of units tested for each non-clinical study.
Data Provenance: The studies are non-clinical (bench testing), so there's no patient data involved in this 510(k) summary. These tests would have been conducted in a laboratory setting by the manufacturer or a contract research organization.

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

This question is not applicable in the context of this 510(k) submission.

Ground Truth for Non-Clinical Tests: For mechanical and material tests, the "ground truth" is established by adherence to recognized standards (e.g., ISO, ASTM) and engineering principles, not by expert consensus on clinical images or diagnoses. The "experts" would be the engineers and scientists performing and interpreting these tests.
The document implies that the internal experts of b-ONE ORTHO, Corp. and potentially external labs were involved in conducting and evaluating these non-clinical tests, following established regulatory and scientific guidelines.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies, not for non-clinical mechanical testing of medical devices.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. This 510(k) is for a total knee replacement system, which is a physical implant, not an AI-assisted diagnostic tool or an imaging modality. There are no "human readers" or "AI assistance" involved in its direct function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The MOBIO Total Knee System is a physical medical device (an implant), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As this is a non-clinical 510(k) submission for a physical implant, the "ground truth" for the performance studies refers to:

Adherence to validated test methods and standards: For example, fatigue testing would be evaluated against established standards for implant longevity.
Material specifications: Conformance to established material properties for the titanium alloy.
Design specifications: Proof that the device meets its design intent, often through dimensional verification and mechanical simulation/testing.
Biocompatibility standards: Compliance with ISO 10993 series for biological evaluation of medical devices.

8. The sample size for the training set

This question is not applicable. As this device is a physical implant and not an AI algorithm, there is no "training set" in the machine learning sense. The "training" for such a device comes from engineering design, material science, and prior knowledge from predicate devices.

9. How the ground truth for the training set was established

This question is not applicable, as there is no "training set" for this type of medical device submission.

Summary

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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

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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)

· 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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TRADITIONAL 510(K) SUMMARY As required by 21 CFR 807.92

Submitter Information:

Submitter's Name:	b-ONE ORTHO, Corp.
Address:	3 Wing DriveSuite 259Cedar 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):	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:	b-ONE MOBIO PS Tibial Baseplate; K180446
Legally Marketed ReferenceDevices Used to SupportSubstantial Equivalence:	Stryker Triathlon T/S Universal Baseplateand Cemented Stems; K070095DePuy 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 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

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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.

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.