# K081127: Accin Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Accelerated Innovation, LLC
- Decided: Oct 17, 2008 after 179 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- 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: 1 generation back to K962152 (1996). 3 ancestors in all.
25 later devices descend from it; 9 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962152: Osteonics Scorpio Posteriorly Stabilized Total Knee System, Osteonics Corp. (1996) Summary page 1.
- K974556: Osteonics Scorpio Posterior Cruciate Retaining Total Knee System, Osteonics Corp. (1998) Summary page 1.
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO, Zimmer, Inc. (1999) Summary page 1.

## Most influential descendants
- K141635: Arthrex Ibalance Tka System (2014), 15 descendants of its own
- K151256: Arthrex BioSync® Bone Wedge (2015), 10 descendants of its own
- K192645: Trigon™ Ti Stand-Alone Wedge Fixation System (2019), 7 descendants of its own
- K193414: Trigon HA Stand-Alone Wedge Fixation System (2020), 6 descendants of its own
- K203445: Trigon HA Stand-Alone Wedge Fixation System (2020), 5 descendants of its own

## Recalls of this device
- Dec 17, 2015 · Class II · Z-1195-2016: Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.

## Indications for use
The ACCIN Total Knee System components are for use in total knee arthroplasty as a result of: * 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.

Source page: https://510kreport.com/device/K081127
Methodology: https://510kreport.com/methodology