# K011976: Optetrak Total Knee System Size 0/1 Delta (Line Extension)

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Jul 16, 2001 after 21 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K936079 (1994). 7 ancestors in all.
107 later devices descend from it; 6 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932690: Exactech Cruciate Retaining Cemented Total Knee SY, Exactech, Inc. (1995) Summary page 2.
- K933494: Exactech Posterior Stabilized Cemented Total Knee System, Exactech, Inc. (1995) Summary page 2.
- K935726: Exactech Porous Coated Cruciate Retained Femoral Component, Exactech, Inc. (1994) Summary page 2.
- K933610: Exactech Cemented Total Knee System, Tibial Components, Exactech, Inc. (1995) Summary page 2.
- K932776: Cruciate Retaining Cemented Tibial Components, Exactech, Inc. (1994) Summary page 2.
- K954208: Optetrak Constrained Condylar Knee for Cemented Use Only, Exactech, Inc. (1996) Summary page 2.
- K936079: Ecactech Porous Coated Finned Tibial Tray Compnent, Exactech, Inc. (1994) Summary page 2.
- (no number) Nexgen: named in the summary without a submission number
- (no number) Maxim: named in the summary without a submission number
- (no number) PFC: named in the summary without a submission number

## Most influential descendants
- K030686: Optetrak Total Knee System - Molded Metal-Back Tibial Component (2003), 86 descendants of its own
- K100900: Motivation Knee System (2010), 72 descendants of its own
- K113756: Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly Cross Linked VE Metal Backed PA (2012), 35 descendants of its own
- K122870: Itotal Cruciate Retaining (CR) Knee Replacement System (2013), 33 descendants of its own
- K131467: Itotal Cruciate Retaining (CR) Knee Replacement System (2013), 30 descendants of its own

## Indications for use
The OPTETRAK® Total 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.

Source page: https://510kreport.com/device/K011976
Methodology: https://510kreport.com/methodology