# K152494: Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Nov 25, 2015 after 85 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
Longest line of descent: 2 generations back to K945028 (1996). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946150: Cruciate Retaining (Augmentable) and Constrained Condylar Knee (CCK), Zimmer, Inc. (1995) Summary page 4.
- K013385: Nexgen Complete Knee Solution Rotatng Hinge Knee, Zimmer, Inc. (2002) Summary page 4.

## Most influential descendants
- K173057: Zimmer Knee Joint Replacement Prostheses MR Labeling (2018), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K191625: Persona Revision Knee System (2019), 1 descendant of its own
- K243724: Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (2025), 0 descendants of its own
- K210829: Persona Revision Knee System Femoral Metaphyseal Cones (2021), 0 descendants of its own

## Recalls of this device
- Oct 31, 2018 · Class II · Z-0630-2019: Screw is missing from the package

## Indications for use
For NexGen Augments used with NexGen Knee Systems – Cruciate Retaining (CR), Cruciate Retaining Augmentable (CRA), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS), and Legacy Constrained Condylar Knee (LCCK): This device is indicated for patients with severe knee pain and disability due to: – Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. – Collagen disorders, and/or 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. – The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. • CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only. • NexGen Augments that may be used with cemented CR, CRA, PS, LPS, and LCCK femoral and tibial baseplate components are indicated for cemented use only. For NexGen Augments used with NexGen Rotating Hinge Knee System: This device is indicated for patients with: – Moderate to severe knee instability. – Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle. – Valgus, varus, or flexion deformities. – The salvage of previously failed surgical attempts. This device is intended for cemented use only.

Source page: https://510kreport.com/device/K152494
Methodology: https://510kreport.com/methodology