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. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Feb 19, 2016 as substantially equivalent to K081127 (Accelerated Innovation, LLC, 2008) and 4 other predicates after a 65-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Feb 19, 2016
- Review
- 65 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K933785 (1995). 23 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 7 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 6 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 5 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- 4 generations backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- 3 generations backK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
- 2 generations backK122765 Persona Natural Tibia BaseplatesZimmer, Inc. · 2012 · Recalled
- 1 generation backK152252 Arthrex iBalance TKA SystemArthrex, Inc. · 2015
- This deviceK153586 Arthrex iBalance TKA SystemArthrex, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK171365 Arthrex Knee SystemsArthrex, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −8 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −7 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −6 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| −5 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| −4 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| −3 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
| −2 | K122765 | Persona Natural Tibia Baseplates | Zimmer, Inc. | 2012 | 2 |
| −1 | K152252 | Arthrex iBalance TKA System | Arthrex, Inc. | 2015 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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…ame 888.3560: Prosthesis, Knee, Patellofemorotibial, Semi- CFR Constrained, Cemented, Polymer/Metal/Polymer Predicate Device K081127: Arthrex iBalance® TKA System K133854: Arthrex iBalance® TKA System… | 2008 |
| * | K133854 | Arthrex Ibalance Tka SystemSummary page 4…CFR Constrained, Cemented, Polymer/Metal/Polymer Predicate Device K081127: Arthrex iBalance® TKA System K133854: Arthrex iBalance® TKA System K143047: Arthrex iBalance® Patella Implant, Dome… | 2014 |
| * | K143047 | Arthrex iBalance Patella Implant, DomeSummary page 4…Predicate Device K081127: Arthrex iBalance® TKA System K133854: Arthrex iBalance® TKA System K143047: Arthrex iBalance® Patella Implant, Dome K152252: Arthrex iBalance® TKA System… | 2014 |
| * | K152252 | Arthrex iBalance TKA SystemSummary page 4…K133854: Arthrex iBalance® TKA System K143047: Arthrex iBalance® Patella Implant, Dome K152252: Arthrex iBalance® TKA System K152382: Arthrex iBalance® TKA System Purpose of Submiss… | 2015 |
| * | K152382 | Arthrex iBalance TKA SystemSummary page 4…K143047: Arthrex iBalance® Patella Implant, Dome K152252: Arthrex iBalance® TKA System K152382: Arthrex iBalance® TKA System Purpose of Submission This traditional 510(k) premarket notification is… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171365 | Arthrex Knee Systems | 2017 | 0 |
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 21 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 16 of the 23 ancestors have a recall of any class.
- Of its descendants, K171365 (Arthrex, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K081127.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 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/K153586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153586: 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/K153586
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