· 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 Total Knee System is intended for implantation with bone cement only. b-ONE Total Knee System components are not intended for use with other knee systems.

Device Description

The b-ONE Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, 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 system is a posterior stabilized device type and includes two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.

The System includes left and right femoral components manufactured from cast cobalt chrome. The system includes 30 sizes. Sizes 1-10 are provided in right and left versions. Sizes 3-7 are provided in both standard and narrow configurations, with the narrow sizes having a relatively smaller aspect ratio of the medial-lateral to anterior-posterior widths when compared to the standard sizes. Optional modular distal pegs are included in the system.

The system includes a Patella Component offered in seven sizes of variable diameter and thicknesses. The bone fixation surface incorporates three fixation pegs. The Patella Components are made from Conventional UHMWPE.

The system includes Tibial Inserts which are offered in 40 sizes, size A/1-4 through HJ/7-10 with 8 thicknesses and 48 sizes for PS+ inserts, size A1-2+ through HJ/7-10+ with 8 thicknesses. 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.

The system includes Tibial Baseplates offered in 9 sizes ranging from A-J. Tibial Baseplates are manufactured from forged titanium alloy.

All system components are supplied sterile and are single use devices.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the b-ONE Total Knee System. This type of document is used to demonstrate that a new device is "substantially equivalent" to an existing, legally marketed device (predicate device) and therefore does not require a full Pre-Market Approval (PMA).

It is important to understand that a 510(k) summary for a prosthetic joint like a knee replacement does NOT involve clinical studies or "acceptance criteria" related to diagnostic performance as would be found in AI/ML medical devices.

Instead, the "acceptance criteria" for a knee replacement relate to the performance of the physical components (e.g., strength, fatigue life) and their biocompatibility, demonstrating that the new device functions as safely and effectively as the predicate devices. The "study that proves the device meets the acceptance criteria" refers to non-clinical (bench) tests of the device's materials, design, and mechanical properties.

Therefore, the requested information elements related to AI/ML device evaluations (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

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

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Type of Non-Clinical Test)	Reported Device Performance (Implied by submission)
Tibial Baseplate Fatigue	Demonstrated to be equivalent to predicate devices in fatigue resistance.
Locking Mechanism Strength	Demonstrated to be equivalent to predicate devices in locking mechanism strength.
Tibial Post Fatigue	Demonstrated to be equivalent to predicate devices in tibial post fatigue resistance.
Constraint	Demonstrated to have appropriate constraint comparable to predicate devices.
Contact Area and Contact Stress	Demonstrated contact area and stress characteristics within acceptable limits and comparable to predicate devices.
Tibiofemoral Range of Motion	Demonstrated range of motion comparable to predicate devices.
Characterization of UHMWPE Insert Material	Material properties of the Ultra-High Molecular Weight Polyethylene (UHMWPE) inserts were characterized and found to be acceptable and comparable to predicate devices.
Bacterial Endotoxin Testing	Met established safety criteria for bacterial endotoxin levels.
Shelf Life Studies	Demonstrated appropriate shelf-life for sterility and material integrity.
Biocompatibility	Demonstrated to be biocompatible, indicating no harmful biological reactions.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This is a physical medical device (knee implant), not a diagnostic algorithm. The "test sets" refer to individual device components or representative samples subjected to specific engineering tests, not patient data sets. The data provenance would be laboratory testing results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. "Ground truth" in this context refers to established engineering standards, material specifications, and mechanical performance criteria, not expert consensus on medical images or diagnoses. These tests are conducted by engineers and technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are relevant for subjective interpretations of data, typically in clinical evaluations or AI/ML ground truth establishment. These are objective engineering tests.

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

No. This is a physical knee implant, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant.

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

No. This is a physical knee implant, not an AI/ML algorithm.

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

The "ground truth" for the non-clinical tests is based on established engineering standards, material specifications, mechanical performance criteria, and comparison to the predicate devices' known performance and specifications.

8. The sample size for the training set

Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing processes are developed through engineering and materials science principles.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" for the device's design and manufacturing is established through adherence to recognized industry standards, regulatory requirements, and engineering principles.

Summary

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October 12, 2018

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 and Human Services logo. To the right of that is the FDA logo, which 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 Manager 3 Wing Drive Suite #259 Cedar Knolls, New Jersey 07929

Re: K180446

Trade/Device Name: b-ONE 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: September 5, 2018 Received: September 6, 2018

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Peter G. Allen -S 2018.10.12 12:11:22 -04'00'

FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known)

K180446

Device Name b-ONE Total Knee System

Indications for Use (Describe)

The b-ONE Total Knee System is intended for total knee arthroplasty due to the following conditions:

· 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 Total Knee System is intended for implantation with bone cement only. b-ONE 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:	973-587-8431
Date Prepared:	September 5, 2018
Proprietary Name:	b-ONE 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:	Stryker Triathlon Total Knee Replacement System, K031729, K070095
Legally Marketed ReferenceDevices Used to SupportSubstantial Equivalence:	Stryker Scorpio NRG, K030978Zimmer NexGen LPS, K960279Zimmer NexGen Fluted Stemmed TibialComponent, K963148Depuy Attune PS, K111433Omni Life Science Apex Knee System, K060192Zimmer Persona, K121771Zimmer NexGen All Poly Patella, K933785

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Intended Use:

The b-ONE 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 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 Total Knee System is intended for implantation with bone cement only.

b-ONE Total Knee System components are not intended for use with other knee systems.

Device Description/Technological Characteristics:

The system includes Tibial Baseplates offered in 9 sizes ranging from A-J. Tibial Baseplates are manufactured from forged titanium alloy.

All system components are supplied sterile and are single use devices.

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Comparison of Technological Characteristics

The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The b-ONE® Total Knee System and the predicate devices share the following characteristics:

Materials of construction
Manufacturing processes
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 ●
Locking Mechanism Strength ●
Tibial Post Fatigue
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 b-ONE 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 b-ONE 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.