510(k) Report

510(k) · Cleared

Cleared

b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions

K262341510(k) TraditionalCleared Sep 8, 202660-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

B-One Ortho, Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Sep 8, 2026 as substantially equivalent to K222431 (B-One Ortho, Corp., 2022) after a 60-day review. Its family tree reaches back 2 generations to 2018.

Decided
Sep 8, 2026
Review
60 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K180446 (2018). No later device cites it as a predicate yet.

Reference device: K053514 · Triathlon Total Knee System · Stryker Orthopaedics · 2006 · recalledReference device: K160700 · ATTUNE Revision Knee System · Depuy (Ireland) · 2016 · recalledReference device: K181947 · Persona Revision Knee System · Zimmer, Inc. · 2018 · recalledReference device: K043440 · Smith & Nephew, Inc. Revision Knee System · Smith & Nephew, Inc. · 2005 · recalledK180446 · b-ONE Total Knee System · B-One Ortho, Corp. · 2018K222431 · b-ONER MOBIO Total Knee System · B-One Ortho, Corp. · 20222016201820202022202420262028
K222431 · b-ONER MOBIO Total Knee System · B-One Ortho, Corp. · 2022K180446 · b-ONE Total Knee System · B-One Ortho, Corp. · 20180
  1. Root · 2 generations backK180446 b-ONE Total Knee SystemB-One Ortho, Corp. · 2018
  2. 1 generation backK222431 b-ONER MOBIO Total Knee SystemB-One Ortho, Corp. · 2022
  3. This deviceK262341 b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments…B-One Ortho, Corp. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K180446b-ONE Total Knee SystemB-One Ortho, Corp.2018—
−1K222431b-ONER MOBIO Total Knee SystemB-One Ortho, Corp.2022—
0 (this device)K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem…B-One Ortho, Corp.2026—
FIG. 1 — Lineage of K262341, 2018–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JWH device

  1. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K222431b-ONER MOBIO Total Knee System
Summary page 5
…Devices Device Per Component Information (Primary) b-ONE® Mobio™ Total (K222431), Mobio™ 888.3560 (K053514), Stryker Triathlon Knee System Revision Total Knee System JWH…
B-One Ortho, Corp.2022—
†K053514Triathlon Total Knee SystemStryker Orthopaedics20062
†K160700ATTUNE Revision Knee SystemDepuy (Ireland)20165
†K181947Persona Revision Knee SystemZimmer, Inc.20181
†K043440Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc.20057

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 4.0 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

What is it indicated for?

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…

Read the full statement (174 words)

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.

Indications for use as stated in the FDA summary.

More from B-One Ortho, Corp.

13 FDA decisions under this applicant name. See the company

  • K253357b-ONE® Bipolar HeadB-One Ortho, Corp. · 2026
  • K240528b-ONE® Total Hip SystemB-One Ortho, Corp. · 2024
  • K222431b-ONER MOBIO Total Knee SystemB-One Ortho, Corp. · 2022
  • K213673b-ONE MOBIO Total Knee SystemB-One Ortho, Corp. · 2022
  • K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix…B-One Ortho, Corp. · 2021

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026
  • K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd. · 2026

https://510kreport.com/device/K262341 · printed Nov 6, 2026

Cite this page

510(k) Report. “K262341: b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262341

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026