510(k) · Cleared

Cleared

b-ONE Total Knee System

K180446510(k) TraditionalCleared Oct 12, 2018234-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 Oct 12, 2018 after a 234-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 later devices descend from it.

Decided: Oct 12, 2018
Review: 234 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

2 later devices descend from it, 1 citing it directly.

This deviceK180446 b-ONE Total Knee SystemB-One Ortho, Corp. · 2018
Descendant · cites it directly · 1 of its ownK222431 b-ONER MOBIO Total Knee SystemB-One Ortho, Corp. · 2022
Descendant · 2 generations on · 0 of its ownK262341 b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments…B-One Ortho, Corp. · 2026

Most influential descendants

Showing 2 of 2 · See all

K222431b-ONER MOBIO Total Knee SystemB-One Ortho, Corp. · 2022 · cites it directly1descendant
K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…B-One Ortho, Corp. · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K180446	b-ONE Total Knee System	B-One Ortho, Corp.	2018	—
+1	K222431	b-ONER MOBIO Total Knee System	B-One Ortho, Corp.	2022	—
+2	K262341	b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem…	B-One Ortho, Corp.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0
2026	1	0

FIG. 1 — Lineage of K180446, 2018–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K061383	FDA’s K061383 is Bti Sterile Dental Drills Kit, Bti Abutments and Caps Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	B.T.I. Biotechnology Institute, Sl.	2006	—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K222431	b-ONER MOBIO Total Knee System	B-One Ortho, Corp.	2022	1

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?

Of its descendants, K222431 (B-One Ortho, Corp., 2022) has gone furthest, with 1 descendant of its own.

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. 2018, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	74	14	1,305
2008	17	81	10	1,483
2009	11	168	109	1,870
2010	19	85	32	3,286
2011	25	87	27	5,133
2012	33	85	85	5,203
2013	31	128	31	6,135
2014	33	98	13	6,722
2015	27	87	11	6,881
2016	18	88	17	7,586
2017	25	118	61	12,263
2018	25	90	14	14,071
2019	28	133	5	14,987
2020	22	59	2	12,592
2021	24	61	8	9,408
2022	17	56	12	8,364
2023	20	57	67	8,947
2024	19	89	7	10,828
2025	20	55	2	9,306
2026	12	63	4	—

What is it indicated for?

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…

Read the full statement (163 words)

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K180446 · printed Nov 6, 2026

Cite this page

510(k) Report. “K180446: b-ONE Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180446

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026