510(k) · Cleared
ClearedArthrex iBalance BiCompartmental Arthroplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Apr 12, 2016 as substantially equivalent to K073120 (Accelerated Innovation, LLC, 2008) and 4 other predicates after a 53-day review. Its family tree reaches back 7 generations to 1994. 3 later devices descend from it.
- Decided
- Apr 12, 2016
- Review
- 53 days
- Class
- Class II
- Product code
- KRR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K943462 (1994). 35 ancestors in all, the oldest K880155 (1988). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 6 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 5 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 4 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 3 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 2 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 1 generation backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- This deviceK160461 Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK200433 iBalance UKA Tibial Tray ImplantArthrex, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK251453 Arthrex iBalance Partial Knee SystemArthrex, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK171365 Arthrex Knee SystemsArthrex, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −6 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −5 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −4 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −3 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −2 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −1 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| 0 (this device) | K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | Arthrex, Inc. | 2016 | — |
| +1 | K200433 | iBalance UKA Tibial Tray Implant | Arthrex, Inc. | 2020 | — |
| +2 | K251453 | Arthrex iBalance Partial Knee System | Arthrex, Inc. | 2025 | — |
| +1 | K171365 | Arthrex Knee Systems | Arthrex, Inc. | 2017 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 KRR? 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 KRR device
- #1 K231253 Overture Orthopaedics Patellofemoral Systemscore 5.6 · 1 generation · 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 |
|---|---|---|---|
| * | K073120 | Accin Patellofemoral SystemSummary page 4…HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal Polymer CFR 888.3520 Predicate Device K073120: ACCIN Patellofemoral System K063782, K060670: ACCIN UNI-Knee System… | 2008 |
| * | K063782 | Accin Uni-Knee SystemSummary page 4…Cemented, Metal Polymer CFR 888.3520 Predicate Device K073120: ACCIN Patellofemoral System K063782, K060670: ACCIN UNI-Knee System K090763: Mako Restoris MCK K0… | 2007 |
| * | K060670 | Accin Uni-Knee SystemSummary page 4…Cemented, Metal Polymer CFR 888.3520 Predicate Device K073120: ACCIN Patellofemoral System K063782, K060670: ACCIN UNI-Knee System K090763: Mako Restoris MCK K052917: St… | 2006 |
| * | K090763 | Restoris Multicompartmental Knee (MCK) SystemSummary page 4…Predicate Device K073120: ACCIN Patellofemoral System K063782, K060670: ACCIN UNI-Knee System K090763: Mako Restoris MCK K052917: Stryker Compartmental Knee System Purpose of Submission… | 2009 |
| * | K052917 | Stryker Compartmental Knee SystemSummary page 4…K063782, K060670: ACCIN UNI-Knee System K090763: Mako Restoris MCK K052917: Stryker Compartmental Knee System Purpose of Submission This traditional 510(k) premarket notification is… | 2005 |
What descends from it? (3)
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 22 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 18 of the 35 ancestors have a recall of any class.
- Of its descendants, K200433 (Arthrex, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K073120.
How does its category compare?
All KRR devicesKRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, 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 · KRR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KRR
116in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRR
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRR
36in 2025
MAUDE reports naming product code KRR, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 116 | 0 | 0 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 1 | — | 1 | 9 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 1 | — | 1 | 14 |
| 2017 | 0 | — | 2 | 15 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 8 |
| 2022 | 1 | — | 3 | 9 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (95 words)
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 as stated in the FDA summary.
https://510kreport.com/device/K160461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160461: Arthrex iBalance BiCompartmental Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160461
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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