510(k) · Cleared
ClearedAccin Uni-Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accin Corporation · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Jan 19, 2007 as substantially equivalent to K060670 (Accin Corporation, 2006) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1988. 4 later devices descend from it.
- Decided
- Jan 19, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K880155 (1988). 9 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK880155 Miller/Galante Precoat Unicompartmental KneeZimmer, Inc. · 1988 · Recalled
- 2 generations backK033363 Zimmer Unicompartmental Knee SystemZimmer, Inc. · 2004 · Recalled
- 1 generation backK060670 Accin Uni-Knee SystemAccin Corporation · 2006 · Recalled
- This deviceK063782 Accin Uni-Knee SystemAccin Corporation · 2007
- Descendant · cites it directly · 3 of its ownK160461 Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK200433 iBalance UKA Tibial Tray ImplantArthrex, Inc. · 2020
- Descendant · 3 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 4 of 4 · See all- K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc. · 2016 · cites it directly3descendants
- K200433iBalance UKA Tibial Tray ImplantArthrex, Inc. · 2020 · 2 generations on1descendant
- K251453Arthrex iBalance Partial Knee SystemArthrex, Inc. · 2025 · 3 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −3 | K880155 | Miller/Galante Precoat Unicompartmental Knee | Zimmer, Inc. | 1988 | 1 |
| −2 | K033363 | Zimmer Unicompartmental Knee System | Zimmer, Inc. | 2004 | 3 |
| −1 | K060670 | Accin Uni-Knee System | Accin Corporation | 2006 | 1 |
| 0 (this device) | K063782 | Accin Uni-Knee System | Accin Corporation | 2007 | — |
| +1 | K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | Arthrex, Inc. | 2016 | — |
| +2 | K200433 | iBalance UKA Tibial Tray Implant | Arthrex, Inc. | 2020 | — |
| +3 | 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 |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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 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 1…e, Femorotibial, Non-Constrained, Cemented, Metal Polymer, 21 CFR 888.3520, Class 11 Predicate Device: Accin UNI-Knee System - K060670 Zimmer Unicompartmental Knee System - K033363 Device Description: The ACCIN UNI-Knee Syst… | 2006 |
| * | K033363 | Zimmer Unicompartmental Knee SystemSummary page 1…Polymer, 21 CFR 888.3520, Class 11 Predicate Device: Accin UNI-Knee System - K060670 Zimmer Unicompartmental Knee System - K033363 Device Description: The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and… | 2004 |
What descends from it? (4)
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 19 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 9 ancestors have a recall of any class.
- Of its descendants, K160461 (Arthrex, Inc., 2016) has gone furthest, with 3 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. 2007, 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 ACCIN UNI-Knee System components are 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 as stated in the FDA summary.
https://510kreport.com/device/K063782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063782: Accin Uni-Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063782
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