510(k) · Cleared
Recalled · Class II · 2019Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK Trabecular Metal (TM) Coupled Tibial
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Trabecular Metal Technology · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Jun 29, 2012 as substantially equivalent to K102896 (Zimmer Trabecular Metal Technology, 2010) and 4 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1998. 7 later devices descend from it. It has been recalled once.
- Decided
- Jun 29, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 4 generations to K982302 (1998). 9 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 3 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 2 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 1 generation backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
- This deviceK120990 Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals…Zimmer Trabecular Metal Technology · 2012
- Descendant · cites it directly · 5 of its ownK182346 TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK241597 Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK251717 Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK252777 Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK253314 Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc. · 2018 · cites it directly5descendants
- K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc. · 2025 · 2 generations on3descendants
- K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025 · 3 generations on1descendant
- K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc. · 2025 · 3 generations on0descendants
- K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −3 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −2 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −1 | K053340 | Trabecular Metal Tibial and Femoral Cone Augments | Zimmer Trabecular | 2006 | — |
| 0 (this device) | K120990 | Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen… | Zimmer Trabecular Metal Technology | 2012 | — |
| +1 | K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | Exactech, Inc. | 2018 | — |
| +2 | K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025 | — |
| +3 | K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025 | — |
| +3 | K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | 2025 | — |
| +3 | K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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? (5)
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 |
|---|---|---|---|
| * | K102896 | Trabecular Metal Tibial Cone AugmentsSummary page 2…were shown to be substantially equivalent to the legally marketed predicate devices. These predicates include Zimmer's NexGeno Trabecular MetalrM Tibial Cone Augments (K]102896, K03 1962, K053340), and Zimmer's Nexoene Complete Knee Solution - Trabecular MetaTNI Augments (K024161, K040487). The NexGen® L… | 2010 |
| * | K031962 | Nexgen Trabecular Metal Tibial Cone AugmentsSummary page 2…wn to be substantially equivalent to the legally marketed predicate devices. These predicates include Zimmer's NexGeno Trabecular MetalrM Tibial Cone Augments (K]102896, K03 1962, K053340), and Zimmer's Nexoene Complete Knee Solution - Trabecular MetaTNI Augments (K024161, K040487). The NexGen® LCCK Trabec… | 2004 |
| * | K053340 | Trabecular Metal Tibial and Femoral Cone AugmentsSummary page 2…ubstantially equivalent to the legally marketed predicate devices. These predicates include Zimmer's NexGeno Trabecular MetalrM Tibial Cone Augments (K]102896, K03 1962, K053340), and Zimmer's Nexoene Complete Knee Solution - Trabecular MetaTNI Augments (K024161, K040487). The NexGen® LCCK Trabecular Meta… | 2006 |
| * | K024161 | Nexgen Complete Knee Solution - Trabecular Metal AugmentsSummary page 2…nclude Zimmer's NexGeno Trabecular MetalrM Tibial Cone Augments (K]102896, K03 1962, K053340), and Zimmer's Nexoene Complete Knee Solution - Trabecular MetaTNI Augments (K024161, K040487). The NexGen® LCCK Trabecular MetalTFM Coupled Tibial ConeSTM have the same material as the previously cleared predicat… | 2003 |
| * | K040487 | Trabecular Metal Knee System AugmentsSummary page 2…mmer's NexGeno Trabecular MetalrM Tibial Cone Augments (K]102896, K03 1962, K053340), and Zimmer's Nexoene Complete Knee Solution - Trabecular MetaTNI Augments (K024161, K040487). The NexGen® LCCK Trabecular MetalTFM Coupled Tibial ConeSTM have the same material as the previously cleared predicate devices… | 2004 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0325-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K182346 (Exactech, Inc., 2018) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K102896.
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. 2012, this device’s year, is highlighted.
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?
The Trabecular Metal LCCK Coupled Tibial Cones are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar knee System, the Trabecular Metal Coupled Tibial Cones are for cementless or cemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120990: Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK Trabecular Metal (TM) Coupled Tibial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120990
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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