510(k) · Cleared
ClearedTrabecular Metal Tibial Cone Augments
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 Dec 13, 2010 after a 74-day review. The FDA summary names its predicate without a number. 17 later devices descend from it.
- Decided
- Dec 13, 2010
- Review
- 74 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 7 citing it directly.
- This deviceK102896 Trabecular Metal Tibial Cone AugmentsZimmer Trabecular Metal Technology · 2010
- Descendant · cites it directly · 7 of its ownK120990 Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals…Zimmer Trabecular Metal Technology · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK182346 TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc. · 2018
- Descendant · 3 generations on · 3 of its ownK241597 Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc. · 2025
- Descendant · cites it directly · 3 of its ownK200653 AMF Revision TT ConesLima Corporate S.P.A. · 2020
- Descendant · 4 generations on · 1 of its ownK251717 Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K120990Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK…Zimmer Trabecular Metal Technology · 2012 · cites it directly7descendants
- K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc. · 2018 · 2 generations on5descendants
- K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc. · 2025 · 3 generations on3descendants
- K200653AMF Revision TT ConesLima Corporate S.P.A. · 2020 · cites it directly3descendants
- K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102896 | Trabecular Metal Tibial Cone Augments | Zimmer Trabecular Metal Technology | 2010 | — |
| +1 | K120990 | Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen… | Zimmer Trabecular Metal Technology | 2012 | 1 |
| +2 | K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | Exactech, Inc. | 2018 | — |
| +3 | K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025 | — |
| +1 | K200653 | AMF Revision TT Cones | Lima Corporate S.P.A. | 2020 | — |
| +4 | K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 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? (1)
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 |
|---|---|---|---|
| * | — | NexGen Trabecular Metal Tibial Cone Augments Named without a submission number |
What descends from it? (17)
See all 177 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120990 | Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK… | 2012 | 7 |
| K200653 | AMF Revision TT Cones | 2020 | 3 |
| K200113 | LINK TrabecuLink Tibial Cones | 2020 | 1 |
| K182085 | Balanced Knee Revision System Trabecular Tibial Cone Augments | 2018 | 0 |
| K170149 | 3DMetal Tibial Cones | 2017 | 0 |
| K141840 | Trabecular Metal Tibial Cone Broach, Trabecular Metal Coupled Tibial Cone Broach | 2014 | 0 |
| K140883 | Vanguard 360 Osseoti Tibial Sleeve Augment | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K120990 (Zimmer Trabecular Metal Technology, 2012) has gone furthest, with 7 descendants of its own.
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. 2010, 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?
Trabecular Metal Tibial Cone Augments 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 - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102896 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102896: Trabecular Metal Tibial Cone Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102896
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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