510(k) · Cleared
Recalled · Class II · 2017Natural-Knee II System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermedics Orthopedics · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on May 22, 1995 after a 515-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 161 later devices descend from it. It has been recalled 6 times.
- Decided
- May 22, 1995
- Review
- 515 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 6
- Predicates
- 0
161 later devices descend from it, 8 citing it directly.
- This deviceK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995
- Descendant · cites it directly · 96 of its ownK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · cites it directly · 42 of its ownK090705 Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · Recalled
- Descendant · cites it directly · 33 of its ownK112906 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012
- Descendant · 2 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
Showing 5 of 161 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 161 · See all- K113369Zimmer Persona Knee SystemZimmer, Inc. · 2012 · cites it directly96descendants
- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 2 generations on59descendants
- K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · cites it directly42descendants
- K112906Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012 · cites it directly33descendants
- K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 2 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936159 | Natural-Knee II System | Intermedics Orthopedics | 1995 | — |
| +1 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
| +2 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| +1 | K090705 | Balanced Knee System Ultracongruent Tibial Insert | Ortho Development Corp. | 2009 | 1 |
| +1 | K112906 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2012 | — |
| +2 | K140942 | Klassic Knee Tibial Stem Extension | Total Joint Orthopedics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 9 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 13 | 0 |
| 2020 | 13 | 0 |
| 2021 | 15 | 0 |
| 2022 | 11 | 0 |
| 2023 | 14 | 0 |
| 2024 | 15 | 0 |
| 2025 | 11 | 0 |
| 2026 | 12 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (161)
See all 1618 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113369 | Zimmer Persona Knee System | 2012 | 96 |
| K090705 | Balanced Knee System Ultracongruent Tibial Insert | 2009 | 42 |
| K112906 | Klassic Knee System | 2012 | 33 |
| K032522 | Tecres Spacer-K Temporary Knee Prosthesis | 2004 | 27 |
| K162422 | Klassic Knee System | 2016 | 23 |
| K221479 | Persona Personalized Knee System | 2022 | 8 |
| K102578 | Apex PS Knee System | 2011 | 8 |
| K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | 2018 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2017 | Class II | Z-1033-2018 | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. |
| Jan 11, 2016 | Class II | Z-0839-2016 | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. |
| Feb 25, 2014 | Class II | Z-1262-2014 | Storage | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component… |
| Feb 25, 2014 | Class II | Z-1249-2014 | Storage | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component… |
| Aug 30, 2013 | Class II | Z-0075-2014 | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. |
| Aug 30, 2013 | Class II | Z-0078-2014 | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113369 (Zimmer, Inc., 2012) has gone furthest, with 96 descendants of its own.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
https://510kreport.com/device/K936159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K936159: Natural-Knee II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K936159
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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