# K160484: Optetrak Advanced Patella

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Mar 18, 2016 after 25 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954208 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K223252: TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (2023), 0 descendants of its own

## Recalls of this device
- Apr 18, 2024 · Class II · Z-2155-2024: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Apr 18, 2024 · Class II · Z-2157-2024: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Apr 18, 2024 · Class II · Z-2158-2024: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Apr 18, 2024 · Class II · Z-2156-2024: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Nov 21, 2023 · Class II · Z-0582-2024: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

## Indications for use
The OPTETRAK Comprehensive Knee Systems are 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. In the USA, the OPTETRAK Comprehensive Knee Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.

Source page: https://510kreport.com/device/K160484
Methodology: https://510kreport.com/methodology