# K010434: Optetrak B-Series Total Knee System

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Mar 13, 2001 after 28 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
No predicates in its family tree.
18 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033883: Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, HI-Flex Posterior-Stabi (2004), 17 descendants of its own
- K093360: Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T (2010), 15 descendants of its own
- K111400: Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component (2011), 12 descendants of its own
- K121307: Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak Logic CR Femoral Component, Siz (2012), 11 descendants of its own
- K123687: Optetrak Logic Porous Femoral Component (2013), 7 descendants of its own

## Recalls of this device
- Aug 31, 2006 · Not classified · Z-0196-2007: Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.

Source page: https://510kreport.com/device/K010434
Methodology: https://510kreport.com/methodology