510(k) · Cleared
ClearedLegion Porous + HA Tibial Baseplates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on May 13, 2010 as substantially equivalent to K030623 (Smith & Nephew, Inc., 2003) and 1 other predicate after a 43-day review. Its family tree reaches back 3 generations to 1998. 12 later devices descend from it.
- Decided
- May 13, 2010
- Review
- 43 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971206 (1998). 13 ancestors in all, the oldest K853730 (1986). 12 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK971206 Meridian ST Femoral Stem and Vitalock Solid Back Shell W/…Howmedica Corp. · 1998 · Recalled
- 2 generations backK023302 Echelon Porous Plus HA Hip StemsSmith & Nephew, Inc. · 2002
- 1 generation backK032683 Genesis II Porous Plus HA Knee SystemSmith & Nephew, Inc. · 2003
- This deviceK100897 Legion Porous + HA Tibial BaseplatesSmith & Nephew, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK211221 Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc. · 2021
- Descendant · cites it directly · 5 of its ownK121393 Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · cites it directly · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 2 of its ownK123159 Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK173331 JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc. · 2017 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc. · 2021 · cites it directly5descendants
- K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly5descendants
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
- K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc. · 2013 · 2 generations on2descendants
- K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971206 | Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating | Howmedica Corp. | 1998 | 1 |
| −2 | K023302 | Echelon Porous Plus HA Hip Stems | Smith & Nephew, Inc. | 2002 | — |
| −1 | K032683 | Genesis II Porous Plus HA Knee System | Smith & Nephew, Inc. | 2003 | — |
| 0 (this device) | K100897 | Legion Porous + HA Tibial Baseplates | Smith & Nephew, Inc. | 2010 | — |
| +1 | K211221 | Porous Patella and Porous Tibia Baseplate | Smith & Nephew, Inc. | 2021 | — |
| +1 | K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | Smith & Nephew, Inc. | 2012 | 4 |
| +1 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +2 | K123159 | Smith & Newphew, Inc. Disposable Knee Instruments | Smith & Nephew, Inc. | 2013 | — |
| +2 | K173331 | JOURNEY II XR Knee Instruments | Smith & Nephew, Inc. | 2017 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K030623 | Smith & Nephew Profix Total Knee SystemSummary page 1…Description Subject of this premarket notification isa review of changes to the Prolix Porous Tibial Baseplates (previously cleared for market via premarket notification K0306231 to result in the Legion Porous + HA Tibia[ Baseplates. The subject devices are uncemented tibial baseplates manufactured from Ti… | 2003 |
| * | K032683 | Genesis II Porous Plus HA Knee SystemSummary page 2…Profix Total Knee System K030623 5/22/03 Genesis IIPorous + HA Knee System K032683 10/15/03 Conclusion As previously noted, this Special 510(k) Premarket Notification is being submitted to reques… | 2003 |
What descends from it? (12)
See all 123 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K211221 (Smith & Nephew, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K030623.
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?
Total knee components are indicated for:
1. Rheumatoid arthritis
2. Post-traumatic arthritis, osteoarthntis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Legion Porous + HA Tibial Baseplates are indicated for use without bone cement, and are single use devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100897 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100897: Legion Porous + HA Tibial Baseplates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100897
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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