# K100900: Motivation Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jun 18, 2010 after 79 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: 3 generations back to K936079 (1994). 17 ancestors in all.
72 later devices descend from it; 8 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905613: MTS Knee System, T & R Mfg., Inc. (1991) Summary page 1.
- K923277: Foundation Knee System, Encore Orthopedics, Inc. (1993) Summary page 1.
- K932425: Foundation Modular Tibial Baseplate, Encore Orthopedics, Inc. (1994) Summary page 1.
- K933539: Foundation Posterior Stabilized Knee, Encore Orthopedics, Inc. (1994) Summary page 1.
- K020114: 3D KNEE, Encore Orthopedics, Inc. (2002) Summary page 1.
- K932690: Exactech Cruciate Retaining Cemented Total Knee SY, Exactech, Inc. (1995) Summary page 1.
- K932776: Cruciate Retaining Cemented Tibial Components, Exactech, Inc. (1994) Summary page 1.
- K933494: Exactech Posterior Stabilized Cemented Total Knee System, Exactech, Inc. (1995) Summary page 1.
- K933610: Exactech Cemented Total Knee System, Tibial Components, Exactech, Inc. (1995) Summary page 1.
- K011976: Optetrak Total Knee System Size 0/1 Delta (Line Extension), Exactech, Inc. (2001)
- K030686: Optetrak Total Knee System - Molded Metal-Back Tibial Component, Exactech, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K131019: Itotal Cruciate Retaining (C) Knee Replacement System (2013), 30 descendants of its own
- K140833: Itotal Posterior Stabilized (PS) Knee Replacement System (2014), 26 descendants of its own

## Recalls of this device
- Dec 12, 2017 · Class II · Z-0327-2018: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
- Dec 12, 2017 · Class II · Z-0328-2018: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
- Dec 12, 2017 · Class II · Z-0326-2018: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
- Dec 12, 2017 · Class II · Z-0329-2018: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.

## Indications for use
Joint replacement is indicated for patients suffering from disability due to: *degenerative, post-traumatic or rheumatoid arthritis; *avascular necrosis of the femoral condyle; *post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; *moderate valgus, varus or flexion deformities; *treatment of fractures that are unmanageable using other techniques. This device may also be indicated in the salvage of previously failed surgical attempts. This system is intended to be used for cemented applications.

Source page: https://510kreport.com/device/K100900
Methodology: https://510kreport.com/methodology