b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
Device Facts
| Record ID | K262341 |
|---|---|
| Device Name | b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions |
| Applicant | B-One Ortho, Corp. |
| Product Code | JWH · Orthopedic |
| Decision Date | Sep 8, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3560 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 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 MOBIO Total Knee System is intended for implantation with bone cement only. The MOBIO Press-Fit Stem Extensions are intended for cementless applications. MOBIO Total Knee System components are not intended for use with other knee systems.
Device Story
Modular knee arthroplasty system components; includes revision cemented tibial augments, cemented tibial stem extensions, and press-fit stem extensions. Used in total knee replacement surgery to restore joint function in patients with degenerative or traumatic joint disease. Components mate with Mobio™ Stemmed Baseplates via threaded junctions. Augments provide structural support; stem extensions provide fixation. Cemented stems use bone cement; press-fit stems are cementless. Operated by orthopedic surgeons in hospital/OR settings. Output is a reconstructed knee joint construct. Benefits include pain relief, restored joint configuration, and improved stability.
Clinical Evidence
Bench testing only. Assessments included stemmed baseplate fatigue testing, stem torque testing, endotoxin testing (USP<85>), and biocompatibility assessment (ISO 10993-1).
Technological Characteristics
Materials: Titanium alloy (Ti-6Al-4V per ASTM F1472 or Ti6Al4V ELI per ASTM F136). Fixation: Cemented (grit blasted with #24 Aluminum Oxide) or cementless (press-fit). Modular design with threaded junctions. Sizes: Augments (5/10mm thickness); Stems (10-24mm diameter, 30-180mm length). Sterilization: Not specified.
Indications for Use
Indicated for adults (22+) requiring total knee arthroplasty due to painful, disabling joint disease (OA, RA, post-traumatic arthritis, avascular necrosis), post-traumatic loss of joint function, moderate varus/valgus/flexion deformity, revision of failed knee replacement, or distal femur/proximal tibia fractures. PS/PS+ components indicated for ligamentous instability, absent/nonfunctioning PCL, or severe anteroposterior instability.
Regulatory Classification
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).
Predicate Devices
- Mobio™ Total Knee System Stemmed Baseplate and Stem Extensions (K222431)
Reference Devices
- Stryker Triathlon Knee (K053514)
- DePuy Attune Cemented Stems (K160700)
- Zimmer Persona Revision Cemented Stems (K181947)
- Smith & Nephew LEGION Stem Extensions (K043440)
Submission Summary (Full Text)
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**U.S. FOOD & DRUG**
ADMINISTRATION
September 8, 2026
B-One Ortho, Corp.
Allison Gecik
Director, US QA & RA
3 Wing Dr., Suite 259
Cedar Knolls, New Jersey 07927
Re: K262341
Trade/Device Name: b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments,
Stem Extensions and Press-Fit Stem Extensions
Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented
prosthesis
Regulatory Class: Class II
Product Code: JWH
Dated: July 9, 2026
Received: July 10, 2026
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 (the 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
available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K262341 - Allison Gecik
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K262341 - Allison Gecik
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assistance/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,
Peter G.
Allen -S
Digitally signed by Peter
G. Allen -S
Date: 2026.09.08
16:30:05 -04'00'
for Lixin Liu, 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 | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262341 | ? |
| Please provide the device trade name(s). | | ? |
| b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | | |
| Please provide your Indications for Use below. | | ? |
| 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 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 MOBIO Total Knee System is intended for implantation with bone cement only. The MOBIO Press-Fit Stem Extensions are intended for cementless applications. MOBIO Total Knee System components are not intended for use with other knee systems. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
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K262341 Page 1 of 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: September 4, 2026
Common Name: Total Knee Replacement System
Proprietary Name: b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
Classification Panel: Orthopedic
Classification: Class II
Classification Regulation/Product Codes:
| Subject Devices | Product Code | Regulation Number | Regulation Name |
| --- | --- | --- | --- |
| b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | JWH | 888.3560 | Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis |
Predicate Device and Reference Device:
| Predicate and Reference Device Alignment to the b-ONE® Mobio™ Total Knee System Components | | | |
| --- | --- | --- | --- |
| Subject Devices | Primary Predicate Device Per Component | Corresponding Predicate Regulatory Information (Primary) | Applicable Reference Devices |
| b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | (K222431), Mobio™ Total Knee System Stemmed Baseplate and Stem Extensions | 888.3560 JWH | (K053514), Stryker Triathlon Knee (K160700) DePuy Attune Cemented Stems (K181947) Zimmer Persona Revision Cemented Stems (K043440) Smith & Nephew LEGION Stem Extensions |
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K262341 Page 2 of 3
# **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 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 MOBIO Total Knee System is intended for implantation with bone cement only. The MOBIO Press-Fit Stem Extensions are intended for cementless applications.
MOBIO Total Knee System components are not intended for use with other knee systems.
# **Device Description/Technological Characteristics for Mobio™ Revision Cemented Tibial Augments**
The Revision Cemented Tibial Augments are manufactured from titanium alloy (Ti-6Al-4V) conforming with ASTM F1472. The Revision Cemented Tibial Augments are compatible with the Mobio™ Stemmed Baseplate (and Stem Extensions). The augments are symmetrical (i.e. can be used in either left or right orientations) and are available in five sizes/footprints in either 5 or 10mm thickness.
# **Device Description/Technological Characteristics for Mobio™ Tibial Stem Extensions**
The Tibial Stem Extensions subject to this 510(k) premarket notification are manufactured from titanium alloy (Ti6Al4V ELI) conforming to ASTM F136. The purpose of this 510(k) premarket notification submission is to expand the current size offering for the Tibial Stem Extensions to include 5 additional diameters (10, 18, 20, 22, and 24mm) with various lengths ranging from 30-180mm. The stems are intended for cemented fixation, and the bone contacting surface is grit blasted using a #24 sized Aluminum Oxide grit blast.
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K262341 Page 3 of 3
## Device Description/Technological Characteristics for Mobio™ Press-Fit Stem Extensions
The Press-Fit Stem Extensions are optional components that may be used to provide additional fixation of the knee prosthesis construct and are compatible with the Mobio™ Stemmed Baseplates. The Mobio™ Stemmed Baseplates mate with the modular Stem Extensions through a threaded junction. The Press-Fit Stem Extensions size offering will include 8 diameters (10, 12, 14, 16, 18, 20, 22, and 24mm) with various lengths ranging from 60-180mm. The Press-Fit Stem Extensions are manufactured from Ti6Al4V ELI conforming to ASTM F136 and are intended for cementless fixation (press-fit applications).
## Comparison of Technological Characteristics (compared to Predicate(s))
The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The b-ONE® Mobio™ Total Knee System components and the predicate devices share the following characteristics:
- Materials of construction
- Sizes within the same range
- Similarity in shape
- Fixation
- Sterilization methods
Minor differences have been noted between the subject and predicate devices in terms of sizing and surface finish. However, the minor differences do not present any different questions regarding safety or effectiveness.
## Performance Testing - Bench
The following performance data/assessments were provided in support of the substantial equivalence determination.
| • Stemmed Baseplate Fatigue Testing Assessment | • Endotoxin Testing (USP<85>) |
| --- | --- |
| • Stemmed Baseplate Stem Torque Testing Assessment | • Biocompatibility Assessment (ISO 10993-1) |
## Conclusion
This subject 510(k) premarket notification is being submitted as a line extension to the existing Mobio™ Total Knee System. 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 Mobio™ Revision Cemented Tibial Augments are compatible with the Mobio™ Stemmed Tibial Baseplates (cleared under K222431). The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function.
In addition, we are submitting this 510(k) premarket notification to expand the size offering of the Stem Extensions to be used with the Mobio™ Stemmed Tibial Baseplates (cleared under K222431) as well as introduce new Press-Fit Stem Extensions that are also indicated to be used with the Mobio™ Stemmed Tibial Baseplates.
The information provided above supports that the b-ONE® Mobio™ Total Knee System components are as safe and effective as the predicate devices with similar intended uses. 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 different questions of safety and effectiveness. The b-ONE® Mobio™ Total Knee System components are substantially equivalent to the predicate devices.
