510(k) · Cleared
Recalled · Class II · 2014Natural-Knee II Constrained Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Dec 8, 1997 after a 90-day review. The FDA summary names its predicate without a number. 154 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 8, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 0
154 later devices descend from it, 4 citing it directly.
- This deviceK973412 Natural-Knee II Constrained Knee SystemSulzer Orthopedics, Inc. · 1997
- Descendant · cites it directly · 111 of its ownK060192 Apex Knee SystemOmni Life Science, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 72 of its ownK073602 Modification to: Apex Knee SystemOmnlife Science · 2008
- Descendant · 2 generations on · 61 of its ownK080842 Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008
- Descendant · 3 generations on · 60 of its ownK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- Descendant · cites it directly · 52 of its ownK021740 Total Knee Cemented, Semi-ConstrainedDj Orthopedics, LLC · 2002
Showing 5 of 154 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 154 · See all- K060192Apex Knee SystemOmni Life Science, Inc. · 2006 · cites it directly111descendants
- K073602Modification to: Apex Knee SystemOmnlife Science · 2008 · 2 generations on72descendants
- K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008 · 2 generations on61descendants
- K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013 · 3 generations on60descendants
- K021740Total Knee Cemented, Semi-ConstrainedDj Orthopedics, LLC · 2002 · cites it directly52descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973412 | Natural-Knee II Constrained Knee System | Sulzer Orthopedics, Inc. | 1997 | — |
| +1 | K060192 | Apex Knee System | Omni Life Science, Inc. | 2006 | 1 |
| +2 | K073602 | Modification to: Apex Knee System | Omnlife Science | 2008 | — |
| +2 | K080842 | Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes] | Omni Life Science, Inc. | 2008 | — |
| +3 | K131353 | Comprehensive Reverse Shoulder - Titanium Glenosphere | Biomet Manufacturing Corp | 2013 | — |
| +1 | K021740 | Total Knee Cemented, Semi-Constrained | Dj Orthopedics, LLC | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 8 | 0 |
| 2015 | 6 | 0 |
| 2016 | 8 | 0 |
| 2017 | 1 | 0 |
| 2018 | 6 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 14 | 0 |
| 2022 | 11 | 0 |
| 2023 | 16 | 0 |
| 2024 | 10 | 0 |
| 2025 | 14 | 0 |
| 2026 | 16 | 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 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? (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 |
|---|---|---|---|
| * | — | Natural-Knee II System Named without a submission number | |
| * | — | Maxim Constrained Knee Named without a submission number | |
| * | — | Coordinate Revision Knee Named without a submission number |
What descends from it? (154)
See all 1544 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2014 | Class II | Z-1948-2015 | Package design/selection | Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a… |
| Feb 25, 2014 | Class II | Z-1256-2014 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060192 (Omni Life Science, Inc., 2006) has gone furthest, with 111 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 | — |
What is it indicated for?
The Natural-Knee™ II Constrained Knee System is intended use in the following diagnostic indications: 1. Patient conditions, including but not limited to, inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis). 2. Correctable valgus-varus deformity and moderate flexion contracture. 3. Those patients with failed previous surgery where pain, deformity…
Read the full statement (100 words)
The Natural-Knee™ II Constrained Knee System is intended use in the following diagnostic indications:
1. Patient conditions, including but not limited to, inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis).
2. Correctable valgus-varus deformity and moderate flexion contracture.
3. Those patients with failed previous surgery where pain, deformity, or dysfunction persist.
4. Revision of previously failed knee arthroplasty.
The Natural-Knee™ II Constrained Knee System is intended is intended only for use with bone cement. Uncemented use of the Natural-Knee™ II Constrained Knee System is considered to be investigational in the United States.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973412 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973412: Natural-Knee II Constrained Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973412
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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