510(k) · Cleared
Recalled · Class II · 2017Accin 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 Jun 2, 2006 as substantially equivalent to K033769 (Howmedica Osteonics Corp., 2004) and 2 other predicates after an 80-day review. Its family tree reaches back 2 generations to 1988. 6 later devices descend from it. It has been recalled once.
- Decided
- Jun 2, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- HSX
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K880155 (1988). 8 ancestors in all. 6 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK880155 Miller/Galante Precoat Unicompartmental KneeZimmer, Inc. · 1988 · Recalled
- 1 generation backK033363 Zimmer Unicompartmental Knee SystemZimmer, Inc. · 2004 · Recalled
- This deviceK060670 Accin Uni-Knee SystemAccin Corporation · 2006
- Descendant · cites it directly · 4 of its ownK063782 Accin Uni-Knee SystemAccin Corporation · 2007
- Descendant · cites it directly · 3 of its ownK160461 Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK200433 iBalance UKA Tibial Tray ImplantArthrex, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK161060 Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK251453 Arthrex iBalance Partial Knee SystemArthrex, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K063782Accin Uni-Knee SystemAccin Corporation · 2007 · cites it directly4descendants
- K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc. · 2016 · cites it directly3descendants
- K200433iBalance UKA Tibial Tray ImplantArthrex, Inc. · 2020 · cites it directly1descendant
- K161060Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc. · 2016 · cites it directly1descendant
- K251453Arthrex iBalance Partial Knee SystemArthrex, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880155 | Miller/Galante Precoat Unicompartmental Knee | Zimmer, Inc. | 1988 | 1 |
| −1 | K033363 | Zimmer Unicompartmental Knee System | Zimmer, Inc. | 2004 | 3 |
| 0 (this device) | K060670 | Accin Uni-Knee System | Accin Corporation | 2006 | — |
| +1 | K063782 | Accin Uni-Knee System | Accin Corporation | 2007 | — |
| +1 | K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | Arthrex, Inc. | 2016 | — |
| +1 | K200433 | iBalance UKA Tibial Tray Implant | Arthrex, Inc. | 2020 | — |
| +1 | K161060 | Arthrex iBalance UKA System Vitamin E Tibial Bearing | Arthrex, Inc. | 2016 | — |
| +2 | K251453 | Arthrex iBalance Partial Knee System | Arthrex, Inc. | 2025 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 2 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033769 | Eius Unicompartmental Knee SystemSummary page 1…ibial, Non-Constrained, Cemented, Metal Polymer, 21 CFR 888.3520, Class II Predicate Device: EIUS Unicompartmental Knee System - K033769 and K992287 Stelkast Unicondylar Knee System - K0032824 Zimmer Unicompa… | 2004 |
| * | K992287 | First Step Unicompartmental Knee SystemSummary page 1…onstrained, Cemented, Metal Polymer, 21 CFR 888.3520, Class II Predicate Device: EIUS Unicompartmental Knee System - K033769 and K992287 Stelkast Unicondylar Knee System - K0032824 Zimmer Unicompartmental Kne… | 1999 |
| Kept off the family tree | K003282 | FDA’s K003282 is Full Auto Blood Pressure Monitor, Model SE-7700H Our reading of the summary gave K003282, FDA’s number for Full Auto Blood Pressure Monitor, Model SE-7700H (Sein Electronics Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Stelkast Unicondylar Knee System”. Kept off the family tree. Summary page 1…R 888.3520, Class II Predicate Device: EIUS Unicompartmental Knee System - K033769 and K992287 Stelkast Unicondylar Knee System - K0032824 Zimmer Unicompartmental Knee System - K033363 Device Description: The ACCIN UNI-Knee Syst… | 2000 |
| * | K033363 | Zimmer Unicompartmental Knee SystemSummary page 1…System - K033769 and K992287 Stelkast Unicondylar Knee System - K0032824 Zimmer Unicompartmental Knee System - K033363 Device Description: The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and… | 2004 |
What descends from it? (6)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 3, 2017 | Class II | Z-0095-2018 | Process control | Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 UFRA, size 1 printed on the patient label inside the box. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 15.5 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K063782 (Accin Corporation, 2007) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K033769.
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.
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/K060670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060670: 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/K060670
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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