510(k) · Cleared
ClearedGenesis II Porous Plus HA Knee System
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 Oct 15, 2003 as substantially equivalent to K030612 (Smith & Nephew, Inc., 2003) and 2 other predicates after a 47-day review. Its family tree reaches back 2 generations to 1998. 19 later devices descend from it.
- Decided
- Oct 15, 2003
- Review
- 47 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K971206 (1998). 6 ancestors in all, the oldest K951987 (1995). 19 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK971206 Meridian ST Femoral Stem and Vitalock Solid Back Shell W/…Howmedica Corp. · 1998 · Recalled
- 1 generation backK023302 Echelon Porous Plus HA Hip StemsSmith & Nephew, Inc. · 2002
- This deviceK032683 Genesis II Porous Plus HA Knee SystemSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 12 of its ownK100897 Legion Porous + HA Tibial BaseplatesSmith & Nephew, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK211221 Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc. · 2021
- Descendant · cites it directly · 5 of its ownK190577 World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd. · 2019
- Descendant · cites it directly · 5 of its ownK121393 Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 4 of its ownK220737 World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee…Signature Orthopaedics Pty, Ltd. · 2022
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K100897Legion Porous + HA Tibial BaseplatesSmith & Nephew, Inc. · 2010 · cites it directly12descendants
- K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc. · 2021 · 2 generations on5descendants
- K190577World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd. · 2019 · cites it directly5descendants
- K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly5descendants
- K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal…Signature Orthopaedics Pty, Ltd. · 2022 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971206 | Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating | Howmedica Corp. | 1998 | 1 |
| −1 | K023302 | Echelon Porous Plus HA Hip Stems | Smith & Nephew, Inc. | 2002 | — |
| 0 (this device) | K032683 | Genesis II Porous Plus HA Knee System | Smith & Nephew, Inc. | 2003 | — |
| +1 | K100897 | Legion Porous + HA Tibial Baseplates | Smith & Nephew, Inc. | 2010 | — |
| +2 | K211221 | Porous Patella and Porous Tibia Baseplate | Smith & Nephew, Inc. | 2021 | — |
| +1 | K190577 | World Knee Total Knee Systems | Signature Orthopaedics Pty, Ltd. | 2019 | — |
| +1 | K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | Smith & Nephew, Inc. | 2012 | 4 |
| +2 | K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E… | Signature Orthopaedics Pty, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K030612 | Genesis II Total Knee System | 2003 |
| * | K002996 | Synergy HA Coated Porous Femoral StemsSummary page 1…substantially equivalent to the Smith SC Nephew Genesis I1 Knee System for Uncenieiited Applications (KO30612), Smith & Nephew Synergy HA on Porous Hip Steins (K002996), and Smith & Nephew Echelon Porous Plus HA Hip St enis (KO23302). D. SURlhl A R Y O F T E C H N O L O G I C A L C O M P A… | 2000 |
| * | K023302 | Echelon Porous Plus HA Hip Stems | 2002 |
What descends from it? (19)
See all 193 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 5 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K100897 (Smith & Nephew, Inc., 2010) has gone furthest, with 12 descendants of its own.
- 8 other devices also cite its predicate K030612.
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.
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 Genesis I1 Total Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result. 3. Failed osteotomies, unicornpartmental 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…
Read the full statement (105 words)
The Genesis I1 Total Knee System is indicated for:
1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
3. Failed osteotomies, unicornpartmental 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 Genesis I1 Total Knee System includes porous and porous plus HA coated devices which are indicated for use with or without bone cement, and are single use devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032683: Genesis II Porous Plus HA Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032683
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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