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 Nov 12, 2015 as substantially equivalent to K081127 (Accelerated Innovation, LLC, 2008) and 1 other predicate after an 80-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.
- Decided
- Nov 12, 2015
- Review
- 80 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962152 (1996). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK962152 Osteonics Scorpio Posteriorly Stabilized Total Knee SystemOsteonics Corp. · 1996 · Recalled
- 2 generations backK081127 Accin Total Knee SystemAccelerated Innovation, LLC · 2008 · Recalled
- 1 generation backK133854 Arthrex Ibalance Tka SystemArthrex, Inc. · 2014
- This deviceK152382 Arthrex iBalance TKA SystemArthrex, Inc. · 2015
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962152 | Osteonics Scorpio Posteriorly Stabilized Total Knee System | Osteonics Corp. | 1996 | 13 |
| −2 | K081127 | Accin Total Knee System | Accelerated Innovation, LLC | 2008 | 1 |
| −1 | K133854 | Arthrex Ibalance Tka System | Arthrex, Inc. | 2014 | — |
| 0 (this device) | K152382 | Arthrex iBalance TKA System | Arthrex, Inc. | 2015 | — |
| +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 |
|---|---|---|
| 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 4…l/polymer porous-coated uncemented prosthesis. 888.3560: Prosthesis, Knee, Patellofemorotibial, | Semi-Constrained, Cemented, Polymer/Metal/Polymer Predicate Device | K081127: Arthrex iBalance® TKA System K133854: Arthrex iBalance® TKA System Purpose of Submission This special 510(k) premarket notifi… | 2008 |
| * | K133854 | Arthrex Ibalance Tka SystemSummary page 4…thesis. 888.3560: Prosthesis, Knee, Patellofemorotibial, | Semi-Constrained, Cemented, Polymer/Metal/Polymer Predicate Device | K081127: Arthrex iBalance® TKA System K133854: Arthrex iBalance® TKA System Purpose of Submission This special 510(k) premarket notification is submitted to obtain clearance… | 2014 |
What descends from it? (2)
2 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 19 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K153586 (Arthrex, Inc., 2016) has gone furthest, with 1 descendant 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. 2015, 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 (124 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 stabilization 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, with the exception of porous coated femoral components which can be used cemented or uncemented (biological fixation).
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/K152382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152382: 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/K152382
Report an extraction error
Are you the manufacturer?
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