510(k) · Cleared
ClearedArthrex Knee Systems
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 Nov 7, 2017 as substantially equivalent to K161060 (Arthrex, Inc., 2016) and 9 other predicates after a 182-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Nov 7, 2017
- Review
- 182 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 9 generations to K933785 (1995). 59 ancestors in all, the oldest K880155 (1988). No later device cites it as a predicate yet.
- Root · 9 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 5 generations between
- 3 generations backK122765 Persona Natural Tibia BaseplatesZimmer, Inc. · 2012 · Recalled
- 2 generations backK152252 Arthrex iBalance TKA SystemArthrex, Inc. · 2015
- 1 generation backK153586 Arthrex iBalance TKA SystemArthrex, Inc. · 2016
- This deviceK171365 Arthrex Knee SystemsArthrex, Inc. · 2017
Show all 9 generations
- Root · 9 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 8 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 7 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 6 generations backK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- 5 generations backK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- 4 generations backK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
- 3 generations backK122765 Persona Natural Tibia BaseplatesZimmer, Inc. · 2012 · Recalled
- 2 generations backK152252 Arthrex iBalance TKA SystemArthrex, Inc. · 2015
- 1 generation backK153586 Arthrex iBalance TKA SystemArthrex, Inc. · 2016
- This deviceK171365 Arthrex Knee SystemsArthrex, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −8 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −7 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| −6 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| −5 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| −4 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
| −3 | K122765 | Persona Natural Tibia Baseplates | Zimmer, Inc. | 2012 | 2 |
| −2 | K152252 | Arthrex iBalance TKA System | Arthrex, Inc. | 2015 | — |
| −1 | K153586 | Arthrex iBalance TKA System | Arthrex, Inc. | 2016 | — |
| 0 (this device) | 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 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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? (10)
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 |
|---|---|---|---|
| * | K161060 | Arthrex iBalance UKA System Vitamin E Tibial BearingSummary page 7…21 CFR 888.3520: Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Polymer Regulatory Class II Predicate Device K161060: Arthrex iBalance UKA System Vitamin E Tibial Bearing K160461: Arthrex iBalance BiCompartmental Arthroplast… | 2016 |
| * | K160461 | Arthrex iBalance BiCompartmental Arthroplasty SystemSummary page 7…d, Metal/Polymer Regulatory Class II Predicate Device K161060: Arthrex iBalance UKA System Vitamin E Tibial Bearing K160461: Arthrex iBalance BiCompartmental Arthroplasty System K153586: Arthrex iBalance TKA System… | 2016 |
| * | K153586 | Arthrex iBalance TKA SystemSummary page 7…K161060: Arthrex iBalance UKA System Vitamin E Tibial Bearing K160461: Arthrex iBalance BiCompartmental Arthroplasty System K153586: Arthrex iBalance TKA System K152382: Arthrex iBalance TKA System K152252: Arthrex iB… | 2016 |
| * | K152382 | Arthrex iBalance TKA SystemSummary page 7…ring K160461: Arthrex iBalance BiCompartmental Arthroplasty System K153586: Arthrex iBalance TKA System K152382: Arthrex iBalance TKA System K152252: Arthrex iBalance TKA System K143047: Arthrex iB… | 2015 |
| * | K152252 | Arthrex iBalance TKA SystemSummary page 7…artmental Arthroplasty System K153586: Arthrex iBalance TKA System K152382: Arthrex iBalance TKA System K152252: Arthrex iBalance TKA System K143047: Arthrex iBalance Patella Implant, Dome K133854:… | 2015 |
| * | K143047 | Arthrex iBalance Patella Implant, DomeSummary page 7…: Arthrex iBalance TKA System K152382: Arthrex iBalance TKA System K152252: Arthrex iBalance TKA System K143047: Arthrex iBalance Patella Implant, Dome K133854: Arthrex iBalance TKA System K073120:… | 2014 |
| * | K133854 | Arthrex Ibalance Tka SystemSummary page 7…Balance TKA System K152252: Arthrex iBalance TKA System K143047: Arthrex iBalance Patella Implant, Dome K133854: Arthrex iBalance TKA System K073120: ACCIN Patellafemoral System K063782: ACCIN UNI-… | 2014 |
| * | K073120 | Accin Patellofemoral SystemSummary page 7…Balance TKA System K143047: Arthrex iBalance Patella Implant, Dome K133854: Arthrex iBalance TKA System K073120: ACCIN Patellafemoral System K063782: ACCIN UNI-Knee System K060670: ACCIN UNI-Knee S… | 2008 |
| * | K063782 | Accin Uni-Knee SystemSummary page 7…Balance Patella Implant, Dome K133854: Arthrex iBalance TKA System K073120: ACCIN Patellafemoral System K063782: ACCIN UNI-Knee System K060670: ACCIN UNI-Knee System Purpose of This Special 510(k) premarket n… | 2007 |
| * | K060670 | Accin Uni-Knee SystemSummary page 7…133854: Arthrex iBalance TKA System K073120: ACCIN Patellafemoral System K063782: ACCIN UNI-Knee System K060670: ACCIN UNI-Knee System Purpose of This Special 510(k) premarket notification is submitted to obtain clearance for the… | 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 22 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 32 of the 59 ancestors have a recall of any class.
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. 2017, 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?
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…
Read the full statement (349 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.
The Arthrex iBalance PFJ components are intended for use in patellofemoral knee arthroplasty in patients with:
*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.
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 stabilized 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).
Arthrex iBalance UKA System is intended 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.
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/K171365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171365: Arthrex Knee Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171365
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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