510(k) · Cleared
ClearediBalance UKA Tibial Tray Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Mar 17, 2020 as substantially equivalent to K060670 (Accin Corporation, 2006) and 1 other predicate after a 25-day review. Its family tree reaches back 8 generations to 1994. 1 later device descends from it.
- Decided
- Mar 17, 2020
- Review
- 25 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K943462 (1994). 36 ancestors in all, the oldest K880155 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 7 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 6 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 5 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 4 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 3 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 2 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- 1 generation backK160461 Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc. · 2016
- This deviceK200433 iBalance UKA Tibial Tray ImplantArthrex, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK251453 Arthrex iBalance Partial Knee SystemArthrex, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251453Arthrex iBalance Partial Knee SystemArthrex, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −7 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −6 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −5 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −4 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −3 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −2 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| −1 | K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | Arthrex, Inc. | 2016 | — |
| 0 (this device) | K200433 | iBalance UKA Tibial Tray Implant | Arthrex, Inc. | 2020 | — |
| +1 | K251453 | Arthrex iBalance Partial Knee System | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 HSX? 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 HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 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 |
|---|---|---|---|
| * | K060670 | Accin Uni-Knee SystemSummary page 4…21 CFR 888.3520: Knee joint femorotibial metal/polymer non-constrained, cemented prosthesis Regulatory Class II Predicate Device K060670: ACCIN UNI-Knee System K160461: Arthrex iBalance BiCompartmental Arthroplasty System Reference Device… | 2006 |
| * | K160461 | Arthrex iBalance BiCompartmental Arthroplasty SystemSummary page 4…er non-constrained, cemented prosthesis Regulatory Class II Predicate Device K060670: ACCIN UNI-Knee System K160461: Arthrex iBalance BiCompartmental Arthroplasty System Reference Device K171365: Arthrex Knee Systems Purpose of Submission… | 2016 |
| † | K171365 | Arthrex Knee Systems | 2017 |
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 |
|---|---|---|---|
| K251453 | Arthrex iBalance Partial Knee System | 2025 | 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 26 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 18 of the 36 ancestors have a recall of any class.
- Of its descendants, K251453 (Arthrex, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K060670.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, 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 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The iBalance UKA Tibial Tray Implant is part of the iBalance UKA System, which is indicated for use in unicompartmental knee arthroplasty as a result of: » Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis; * Correction of functional deformities; * Revision of previous unsuccessful unicompartmental knee replacement or other procedure; * As an alternative to tibial osteotomy in patients with…
Read the full statement (182 words)
The iBalance UKA Tibial Tray Implant is part of the iBalance UKA System, which is indicated for use in unicompartmental knee arthroplasty as a result of:
» Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
* Correction of functional deformities;
* Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
* As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
These components are single use only and are intended for implantation with bone cement.
When used concurrently, the Arthrex iBalance UKA and PFJ systems, create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multi-compartmental knee arthroplasty in patients with:
- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- Correction of functional deformities;
- Revision of previous unsuccessful partial knee replacement or other procedure.
The BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee.
These components are single use only and are intended for implantation with bone cement.
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/K200433 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200433: iBalance UKA Tibial Tray Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200433
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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