PMA · Approved
ApprovedNatural-Knee (R) and Natural Knee (R)II W/Csti (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzermedica · MBD Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Approved on Mar 21, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 1,162-day review. 145 later devices descend from it.
- Decided
- Mar 21, 1997
- Review
- 1,162 days
- Class
- Class III
- Product code
- MBD
- Recalls
- None
145 later devices descend from it, 2 citing it directly.
- This deviceP940002 Natural-Knee (R) and Natural Knee (R)II W/Csti (TM)Sulzermedica · 1997
- Descendant · cites it directly · 123 of its ownK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 117 of its ownK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 96 of its ownK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014
Showing 5 of 145 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 145 · See all- K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · cites it directly123descendants
- K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · 2 generations on117descendants
- K113369Zimmer Persona Knee SystemZimmer, Inc. · 2012 · 2 generations on96descendants
- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 3 generations on59descendants
- K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 3 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P940002 | Natural-Knee (R) and Natural Knee (R)II W/Csti (TM) | Sulzermedica | 1997 | — |
| +1 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| +2 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| +2 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
| +3 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| +3 | K140833 | Itotal Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 11 | 0 |
| 2020 | 11 | 0 |
| 2021 | 18 | 0 |
| 2022 | 8 | 0 |
| 2023 | 9 | 0 |
| 2024 | 14 | 0 |
| 2025 | 10 | 0 |
| 2026 | 13 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (145)
See all 1452 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?
- Of its descendants, K070214 (Zimmer, Inc., 2007) has gone furthest, with 123 descendants of its own.
How does its category compare?
All MBD devicesMBD Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBD
FDA has decided no MBD device since 2007.
Median 510(k) review, days · MBD
Too few MBD 510(k)s in any year since 2007 to give a median.
Recalls per year · MBD
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBD
1in 2025
MAUDE reports naming product code MBD, 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 | 0 | — | 1 | 6 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P940002 · printed Nov 5, 2026
Cite this page
510(k) Report. “P940002: Natural-Knee (R) and Natural Knee (R)II W/Csti (TM).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P940002
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026