510(k) · Cleared
ClearedLegion Porous Plus HA Primary Femoral Components
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 Dec 21, 2009 as substantially equivalent to K073325 (Smith & Nephew, Inc., 2007) after a 209-day review. Its family tree reaches back 3 generations to 1995. 7 later devices descend from it.
- Decided
- Dec 21, 2009
- Review
- 209 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K951987 (1995). 4 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 2 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 1 generation backK073325 Legion Porous PrimarySmith & Nephew, Inc. · 2007
- This deviceK091543 Legion Porous Plus HA Primary Femoral ComponentsSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- Descendant · cites it directly · 1 of its ownK223548 GMK Sphere & GMK SpheriKA CementlessMedacta International S.A. · 2023
- Descendant · 2 generations on · 0 of its ownK262057 GMK ExtensionMedacta International SA · 2026
- Descendant · 2 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
- K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A. · 2023 · cites it directly1descendant
- K262057GMK ExtensionMedacta International SA · 2026 · 2 generations on0descendants
- K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
- K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −2 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −1 | K073325 | Legion Porous Primary | Smith & Nephew, Inc. | 2007 | — |
| 0 (this device) | K091543 | Legion Porous Plus HA Primary Femoral Components | Smith & Nephew, Inc. | 2009 | — |
| +1 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +1 | K223548 | GMK Sphere & GMK SpheriKA Cementless | Medacta International S.A. | 2023 | — |
| +2 | K262057 | GMK Extension | Medacta International SA | 2026 | — |
| +2 | K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026 | — |
| +2 | K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K073325 | Legion Porous PrimarySummary page 1…ct Code: MBH Device Description Legion Porous Plus HA Primary Femoral Components are geometrically identical to the Legion Porous Primary femoral components cleared via K073325. This premarket notification seeks only to add a hydroxylapatite (HA) coating to the porous coated areas of the femoral implants.… | 2007 |
| † | K032683 | Genesis II Porous Plus HA Knee System | 2003 |
What descends from it? (7)
3 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 14 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K230653 (Smith & Nephew, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K073325.
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. 2009, 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 rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate tong-term result; failed osteotornies, unicomparimental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. The Smith & Nephew Legion Porous Plus HA Primary Femoral Components 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/K091543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091543: Legion Porous Plus HA Primary Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091543
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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