510(k) · Cleared
ClearedArthrex Ibalance Tka System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 27, 2014 as substantially equivalent to K081127 (Accelerated Innovation, LLC, 2008) after a 70-day review. Its family tree reaches back 2 generations to 1996. 4 later devices descend from it.
- Decided
- Feb 27, 2014
- Review
- 70 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K962152 (1996). 4 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK962152 Osteonics Scorpio Posteriorly Stabilized Total Knee SystemOsteonics Corp. · 1996 · Recalled
- 1 generation backK081127 Accin Total Knee SystemAccelerated Innovation, LLC · 2008 · Recalled
- This deviceK133854 Arthrex Ibalance Tka SystemArthrex, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK152382 Arthrex iBalance TKA SystemArthrex, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK143047 Arthrex iBalance Patella Implant, DomeArthrex, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK153586 Arthrex iBalance TKA SystemArthrex, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK171365 Arthrex Knee SystemsArthrex, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K152382Arthrex iBalance TKA SystemArthrex, Inc. · 2015 · cites it directly2descendants
- K143047Arthrex iBalance Patella Implant, DomeArthrex, Inc. · 2014 · cites it directly2descendants
- K153586Arthrex iBalance TKA SystemArthrex, Inc. · 2016 · cites it directly1descendant
- K171365Arthrex Knee SystemsArthrex, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962152 | Osteonics Scorpio Posteriorly Stabilized Total Knee System | Osteonics Corp. | 1996 | 13 |
| −1 | K081127 | Accin Total Knee System | Accelerated Innovation, LLC | 2008 | 1 |
| 0 (this device) | K133854 | Arthrex Ibalance Tka System | Arthrex, Inc. | 2014 | — |
| +1 | K152382 | Arthrex iBalance TKA System | Arthrex, Inc. | 2015 | — |
| +1 | K143047 | Arthrex iBalance Patella Implant, Dome | Arthrex, Inc. | 2014 | — |
| +1 | K153586 | Arthrex iBalance TKA System | Arthrex, Inc. | 2016 | — |
| +1 | K171365 | Arthrex Knee Systems | Arthrex, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
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
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081127 | Accin Total Knee SystemSummary page 1…Patel lofemorot ibial. Semi- CFR Constrained. Cemented. Polymer/Metal/Polymer Predicate Device K08 1127: AccinTMl Total Knee System Purpose ofSubmission This special 510(k) premarket notification is submitted to… | 2008 |
| * | — | Arthrex iBalance® TKA System Named without a submission number |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K152382 (Arthrex, Inc., 2015) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K081127.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 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 Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for: * Painful, disabling joint disease of the knee resulting from degenerative arthritis, 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: * Revisions of previous…
Read the full statement (107 words)
The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for:
* Painful, disabling joint disease of the knee resulting from degenerative arthritis, 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:
* Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
* Ligamentous instability requiring implant bearing surfaces with increased constraint;
* Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133854: Arthrex Ibalance Tka System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133854
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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