# K060670: Accin Uni-Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Accin Corporation
- Decided: Jun 2, 2006 after 80 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K880155 (1988). 8 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033769: Eius Unicompartmental Knee System, Howmedica Osteonics Corp. (2004) Summary page 1.
- K992287: First Step Unicompartmental Knee System, Howmedica Osteonics Corp. (1999) Summary page 1.
- K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K003282: Full Auto Blood Pressure Monitor, Model SE-7700H, Sein Electronics Co., Ltd. (2000). 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.

## Most influential descendants
- K063782: Accin Uni-Knee System (2007), 4 descendants of its own
- K160461: Arthrex iBalance BiCompartmental Arthroplasty System (2016), 3 descendants of its own
- K200433: iBalance UKA Tibial Tray Implant (2020), 1 descendant of its own
- K161060: Arthrex iBalance UKA System Vitamin E Tibial Bearing (2016), 1 descendant of its own
- K251453: Arthrex iBalance Partial Knee System (2025), 0 descendants of its own

## Recalls of this device
- Oct 3, 2017 · Class II · Z-0095-2018: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K060670
Methodology: https://510kreport.com/methodology