# K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 9, 2003 after 189 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933785 (1995). 4 ancestors in all.
193 later devices descend from it; 8 cite it directly.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933785: Next Generation Knee System, Zimmer, Inc. (1995) Summary page 1.
- K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components, Zimmer, Inc. (2002)
- K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces, Zimmer, Inc. (1996) Summary page 1.

## Most influential descendants
- K072160: Nexgen Trabecular Metal Tibial Tray (2007), 108 descendants of its own
- K072619: Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous Femoral Components (2007), 102 descendants of its own
- K081023: Evolis Total Knee System (2008), 78 descendants of its own
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K043101: Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem Extensions (2005), 59 descendants of its own

## Recalls of this device
- Mar 28, 2024 · Class II · Z-1608-2024: Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
- Nov 29, 2017 · Class II · Z-1039-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1030-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1038-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1040-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1041-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1048-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Apr 30, 2012 · Class II · Z-2092-2012: The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. T
- Apr 30, 2012 · Class II · Z-2091-2012: The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. T
- Mar 14, 2011 · Not classified · Z-1993-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o
- Mar 14, 2011 · Not classified · Z-1996-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o
- Mar 14, 2011 · Not classified · Z-2174-2011: The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of w
- Mar 14, 2011 · Not classified · Z-1995-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o
- Mar 14, 2011 · Not classified · Z-1992-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o
- Mar 14, 2011 · Not classified · Z-1997-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o
- Mar 14, 2011 · Not classified · Z-1988-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o
- Mar 14, 2011 · Not classified · Z-2173-2011: The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of w
- Mar 14, 2011 · Not classified · Z-1994-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o
- Mar 14, 2011 · Not classified · Z-1985-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o
- Mar 14, 2011 · Not classified · Z-1989-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o
- Mar 14, 2011 · Not classified · Z-1986-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o
- Mar 14, 2011 · Not classified · Z-1991-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o
- Mar 14, 2011 · Not classified · Z-1987-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o
- Mar 14, 2011 · Not classified · Z-1990-2011: The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports o

## Indications for use
This device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic &tis, polyarthritis. - Collagen disorders, andor avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is potellofemoral erosion, dysfunction or prior patellectomy. - Moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical attempts or For a knee in which satisfactors stabiIity in flexion cannot be obtained at the time of surgery, CR,LPS and CR-Flex porous coaled femoral or tibial baseplate components may be used cemented or uncernented (biological fixation). All other femoral, tibial baseplate md dl-polyethylene patella components (including H m C P coated) are indicated for cemented USE onIy .

Source page: https://510kreport.com/device/K031061
Methodology: https://510kreport.com/methodology