510(k) · Cleared
Recalled · Class II · 2024Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Oct 9, 2003 as substantially equivalent to K933785 (Zimmer, Inc., 1995) and 2 other predicates after a 189-day review. Its family tree reaches back 2 generations to 1995. 193 later devices descend from it. It has been recalled 24 times.
- Decided
- Oct 9, 2003
- Review
- 189 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 24
- Predicates
- 3
Its longest line of descent runs back 2 generations to K933785 (1995). 4 ancestors in all. 193 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 1 generation backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- This deviceK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003
- Descendant · cites it directly · 108 of its ownK072160 Nexgen Trabecular Metal Tibial TrayZimmer, Inc. · 2007 · Recalled
- Descendant · cites it directly · 102 of its ownK072619 Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions…Zimmer, Inc. · 2007 · Recalled
- Descendant · cites it directly · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- Descendant · 2 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · cites it directly · 59 of its ownK043101 Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw…Zimmer, Inc. · 2005 · Recalled
Showing 5 of 193 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 193 · See all- K072160Nexgen Trabecular Metal Tibial TrayZimmer, Inc. · 2007 · cites it directly108descendants
- K072619Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous…Zimmer, Inc. · 2007 · cites it directly102descendants
- K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · cites it directly78descendants
- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 2 generations on59descendants
- K043101Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem ExtensionsZimmer, Inc. · 2005 · cites it directly59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −1 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| 0 (this device) | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | Zimmer, Inc. | 2003 | — |
| +1 | K072160 | Nexgen Trabecular Metal Tibial Tray | Zimmer, Inc. | 2007 | 1 |
| +1 | K072619 | Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF)… | Zimmer, Inc. | 2007 | 4 |
| +1 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| +2 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| +1 | K043101 | Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem… | Zimmer, Inc. | 2005 | 22 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 10 | 0 |
| 2013 | 12 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 17 | 0 |
| 2021 | 17 | 0 |
| 2022 | 12 | 0 |
| 2023 | 15 | 0 |
| 2024 | 19 | 0 |
| 2025 | 22 | 0 |
| 2026 | 17 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K933785 | Next Generation Knee SystemSummary page 1…888.3565 Predicate Devices: NexGen Complete Knee Solution, manufactured by Zimmer, K933785, cleared January 30, 1995, NexGen Cornplele Knee Solution Cniciate Retaining… | 1995 |
| * | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | 2002 |
| * | K960279 | Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral…Summary page 1…onstrained Condylar Knee (CCK) Femoral Components and Articular Surfaces, manufactured by Zimmer, K960279, cIeared April 26, 1996. Device Description: This submission is for the unce… | 1996 |
What descends from it? (193)
See all 1938 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072160 | Nexgen Trabecular Metal Tibial Tray | 2007 | 108 |
| K072619 | Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous… | 2007 | 102 |
| K081023 | Evolis Total Knee System | 2008 | 78 |
| K043101 | Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem Extensions | 2005 | 59 |
| K042271 | Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular… | 2004 | 16 |
| K122160 | Vanguard XP Knee System | 2013 | 6 |
| K041100 | Nexgen Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate Components | 2004 | 6 |
| K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | 2018 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2024 | Class II | Z-1608-2024 | Process change control | 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 | Packaging | 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 from the bag. |
| Nov 29, 2017 | Class II | Z-1030-2018 | Packaging | 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 from the bag. |
| Nov 29, 2017 | Class II | Z-1038-2018 | Packaging | 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 from the bag. |
| Nov 29, 2017 | Class II | Z-1040-2018 | Packaging | 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 from the bag. |
| Nov 29, 2017 | Class II | Z-1041-2018 | Packaging | 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 from the bag. |
| Nov 29, 2017 | Class II | Z-1048-2018 | Packaging | 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 from the bag. |
| Apr 30, 2012 | Class II | Z-2092-2012 | Component design/selection | 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. The spring clip may fracture or fall… |
| Apr 30, 2012 | Class II | Z-2091-2012 | Component design/selection | 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. The spring clip may fracture or fall… |
| Mar 14, 2011 | Not classified | Z-1993-2011 | Device Design | 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 of the black coating coming off the… |
| Mar 14, 2011 | Not classified | Z-1996-2011 | Device Design | 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 of the black coating coming off the… |
| Mar 14, 2011 | Not classified | Z-2174-2011 | Device Design | 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 which were reported that the patient… |
| Mar 14, 2011 | Not classified | Z-1995-2011 | Device Design | 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 of the black coating coming off the… |
| Mar 14, 2011 | Not classified | Z-1992-2011 | Device Design | 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 of the black coating coming off the… |
| Mar 14, 2011 | Not classified | Z-1997-2011 | Device Design | 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 of the black coating coming off the… |
| Mar 14, 2011 | Not classified | Z-1988-2011 | Device Design | 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 of the black coating coming off the… |
| Mar 14, 2011 | Not classified | Z-2173-2011 | Device Design | 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 which were reported that the patient… |
| Mar 14, 2011 | Not classified | Z-1994-2011 | Device Design | 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 of the black coating coming off the… |
| Mar 14, 2011 | Not classified | Z-1985-2011 | Device Design | 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 of the black coating coming off the… |
| Mar 14, 2011 | Not classified | Z-1989-2011 | Device Design | 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 of the black coating coming off the… |
| Mar 14, 2011 | Not classified | Z-1986-2011 | Device Design | 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 of the black coating coming off the… |
| Mar 14, 2011 | Not classified | Z-1991-2011 | Device Design | 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 of the black coating coming off the… |
| Mar 14, 2011 | Not classified | Z-1987-2011 | Device Design | 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 of the black coating coming off the… |
| Mar 14, 2011 | Not classified | Z-1990-2011 | Device Design | 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 of the black coating coming off the… |
The 5 latest of 24 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 7.7 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K072160 (Zimmer, Inc., 2007) has gone furthest, with 108 descendants of its own.
- 14 other devices also cite its predicate K933785.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
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…
Read the full statement (120 words)
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 .
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031061
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026