# K150890: Exactech Optetrak Logic CC

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: May 29, 2015 after 57 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K936079 (1994). 13 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954208: Optetrak Constrained Condylar Knee for Cemented Use Only, Exactech, Inc. (1996) Summary page 4.
- K093360: Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T, Exactech, Inc. (2010) Summary page 4.
- K933610: Exactech Cemented Total Knee System, Tibial Components, Exactech, Inc. (1995) Summary page 4.
- K012251: Optetrak Total Knee System, Straight Stem Extensions - Additional Sizes, Exactech, Inc. (2001) Summary page 4.

## Most influential descendants
- K152170: Exactech Optetrak Logic Enhanced Assembly (2015), 2 descendants of its own
- K171045: Exactech® Truliant™ Line Extensions (2017), 1 descendant of its own
- K223252: TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (2023), 0 descendants of its own

## Recalls of this device
- Nov 21, 2023 · Class II · Z-0583-2024: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- Jan 27, 2020 · Class II · Z-1364-2020: These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant siz
- May 8, 2018 · Class II · Z-3209-2018: Potentially have non-conforming internal threads.
- Apr 7, 2017 · Class II · Z-2704-2017: Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.

## Indications for use
The Exactech® Optetrak Logic® CC is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The Exactech® Optetrak Logic® CC is indicated for cemented use only.

Source page: https://510kreport.com/device/K150890
Methodology: https://510kreport.com/methodology