510(k) · Cleared
ClearedArthrex iBalance Partial Knee System
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 Jul 1, 2025 as substantially equivalent to K200433 (Arthrex, Inc., 2020) and 1 other predicate after a 50-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Jul 1, 2025
- Review
- 50 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K943462 (1994). 37 ancestors in all, the oldest K880155 (1988). No later device cites it as a predicate yet.
- Root · 9 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 5 generations between
- 3 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- 2 generations backK160461 Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc. · 2016
- 1 generation backK200433 iBalance UKA Tibial Tray ImplantArthrex, Inc. · 2020
- This deviceK251453 Arthrex iBalance Partial Knee SystemArthrex, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 8 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 7 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 6 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 5 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 4 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 3 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- 2 generations backK160461 Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc. · 2016
- 1 generation backK200433 iBalance UKA Tibial Tray ImplantArthrex, Inc. · 2020
- This deviceK251453 Arthrex iBalance Partial Knee SystemArthrex, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −8 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −7 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −6 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −5 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −4 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −3 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| −2 | K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | Arthrex, Inc. | 2016 | — |
| −1 | K200433 | iBalance UKA Tibial Tray Implant | Arthrex, Inc. | 2020 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K200433 | iBalance UKA Tibial Tray ImplantSummary page 6…joint patellofemoral polymer/metal semi- constrained cemented prosthesis Regulatory Class II Primary Predicate Device K200433: iBalance UKA Tibial Tray Implant Additional Predicate Devices K073120: ACCIN Patellafemoral System Reference Predicates… | 2020 |
| * | K073120 | Accin Patellofemoral SystemSummary page 6…constrained cemented prosthesis Regulatory Class II Primary Predicate Device K200433: iBalance UKA Tibial Tray Implant Additional Predicate Devices K073120: ACCIN Patellafemoral System Reference Predicates K171365: Arthrex Knee Systems K161060:… | 2008 |
| † | K171365 | Arthrex Knee Systems | 2017 |
| † | K161060 | Arthrex iBalance UKA System Vitamin E Tibial Bearing | 2016 |
| † | K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | 2016 |
| † | K143047 | Arthrex iBalance Patella Implant, Dome | 2014 |
| † | K063782 | Accin Uni-Knee System | 2007 |
| † | K060670 | Accin Uni-Knee System | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 18 of the 37 ancestors have a recall of any class.
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. 2025, 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 System 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…
Read the full statement (238 words)
The iBalance UKA System 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.
The iBalance PFJ System is indicated for use in patellofemoral joint, (PFJ) knee arthroplasty as a result of:
• Degenerative arthritis in the distal femur and patella;
• A history of patellar dislocation or fracture;
• Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
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 multicompartmental 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 iBalance 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 as stated in the FDA summary.
https://510kreport.com/device/K251453 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251453: Arthrex iBalance Partial Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251453
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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