510(k) · Cleared
ClearedLegion Porous Primary
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 20, 2007 as substantially equivalent to K951987 (Smith & Nephew Richards, Inc., 1995) and 1 other predicate after a 23-day review. Its family tree reaches back 2 generations to 1995. 50 later devices descend from it.
- Decided
- Dec 20, 2007
- Review
- 23 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951987 (1995). 3 ancestors in all. 50 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 1 generation backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- This deviceK073325 Legion Porous PrimarySmith & Nephew, Inc. · 2007
- Descendant · cites it directly · 40 of its ownK111711 Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 37 of its ownK121443 Journey II CR Knee SystemSmith & Nephew, Inc. · 2012
- Descendant · 3 generations on · 18 of its ownK141934 Physica KR Knee SystemLima Corporate S.P.A. · 2015
- Descendant · 3 generations on · 12 of its ownK141471 Journey II XR Knee SystemSmith & Nephew, Inc. · 2014
- Descendant · 4 generations on · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K111711Journey II BCS Knee SystemSmith & Nephew, Inc. · 2011 · cites it directly40descendants
- K121443Journey II CR Knee SystemSmith & Nephew, Inc. · 2012 · 2 generations on37descendants
- K141934Physica KR Knee SystemLima Corporate S.P.A. · 2015 · 3 generations on18descendants
- K141471Journey II XR Knee SystemSmith & Nephew, Inc. · 2014 · 3 generations on12descendants
- K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −1 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| 0 (this device) | K073325 | Legion Porous Primary | Smith & Nephew, Inc. | 2007 | — |
| +1 | K111711 | Journey II BCS Knee System | Smith & Nephew, Inc. | 2011 | 3 |
| +2 | K121443 | Journey II CR Knee System | Smith & Nephew, Inc. | 2012 | — |
| +3 | K141934 | Physica KR Knee System | Lima Corporate S.P.A. | 2015 | — |
| +3 | K141471 | Journey II XR Knee System | Smith & Nephew, Inc. | 2014 | — |
| +4 | K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | 2019 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K951987 | Genesis II Total Knee SystemSummary page 1…ting Genesis 11 Knee System femoral components cleared under the premarket notifications listed below: Genesis 11Knee System (cemented use) K951987 8/22/1 995 Genesis 11Knee System (uncemnented use) K030612 5/27/2003 === Page 2… | 1995 |
| * | K030612 | Genesis II Total Knee SystemSummary page 1…below: Genesis 11Knee System (cemented use) K951987 8/22/1 995 Genesis 11Knee System (uncemnented use) K030612 5/27/2003 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Hea… | 2003 |
What descends from it? (50)
See all 506 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111711 | Journey II BCS Knee System | 2011 | 40 |
| K091543 | Legion Porous Plus HA Primary Femoral Components | 2009 | 7 |
| K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | 2012 | 5 |
| K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and… | 2023 | 3 |
| K261462 | LANDMARK Total Knee System | 2026 | 0 |
| K210566 | LEGION Porous CR Narrow Femoral Components | 2021 | 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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K111711 (Smith & Nephew, Inc., 2011) has gone furthest, with 40 descendants of its own.
- 31 other devices also cite its predicate K951987.
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. 2007, 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 long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Smith & Nephew Legion Porous Primary femorat 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/K073325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073325: Legion Porous Primary.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073325
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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