510(k) · Cleared
ClearedKnee Fusion Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JDS Nail, Fixation, Bone
Cleared on May 4, 2005 as substantially equivalent to K893377 (Richards Medical Co., Inc., 1989) and 1 other predicate after a 20-day review. Its family tree reaches back 1 generation to 1989. 4 later devices descend from it.
- Decided
- May 4, 2005
- Review
- 20 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K893377 (1989). 2 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK893377 Russell-Taylor Intramedullary Knee Fusion NailsRichards Medical Co., Inc. · 1989
- This deviceK050938 Knee Fusion NailSmith & Nephew, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK061783 Knee Fusion NailSmith & Nephew, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK210980 Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK122170 Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK101939 Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH · 2010 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K061783Knee Fusion NailSmith & Nephew, Inc. · 2006 · cites it directly1descendant
- K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc. · 2022 · cites it directly0descendants
- K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly0descendants
- K101939Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K893377 | Russell-Taylor Intramedullary Knee Fusion Nails | Richards Medical Co., Inc. | 1989 | — |
| 0 (this device) | K050938 | Knee Fusion Nail | Smith & Nephew, Inc. | 2005 | — |
| +1 | K061783 | Knee Fusion Nail | Smith & Nephew, Inc. | 2006 | — |
| +1 | K210980 | Smith & Nephew Intramedullary Nail Systems | Smith & Nephew, Inc. | 2022 | 4 |
| +1 | K122170 | Smith & Nephew, Inc. Intramedullary Nail System Instrumentation | Smith & Nephew, Inc. | 2012 | 1 |
| +1 | K101939 | Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System | Merete Medical GmbH | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 1 | 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 JDS? 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 JDS device
- #1 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 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 |
|---|---|---|---|
| * | K893377 | Russell-Taylor Intramedullary Knee Fusion NailsSummary page 4…Knee Fusion Nail is based on its similarities in indications for use, design features, and operational principles to the Russell-Taylor Intramedullary Knee Fusion Nail (K893377 and K983942). Both of these devices are inserted into the medullary canal of long bones for knee arthrodesis. Each one of these d… | 1989 |
| * | K983942 | Intramedullary Nail System, Locking Screw, Nail CapSummary page 4…Nail is based on its similarities in indications for use, design features, and operational principles to the Russell-Taylor Intramedullary Knee Fusion Nail (K893377 and K983942). Both of these devices are inserted into the medullary canal of long bones for knee arthrodesis. Each one of these devices has h… | 1998 |
What descends from it? (4)
4 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?
How does its category compare?
All JDS devicesJDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDS
146in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDS
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDS
497in 2025
MAUDE reports naming product code JDS, 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 | 2 | — | 0 | 161 |
| 2008 | 1 | — | 0 | 169 |
| 2009 | 0 | — | 3 | 160 |
| 2010 | 0 | — | 2 | 70 |
| 2011 | 1 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 195 |
| 2013 | 1 | — | 4 | 284 |
| 2014 | 0 | — | 0 | 388 |
| 2015 | 1 | — | 0 | 316 |
| 2016 | 0 | — | 0 | 506 |
| 2017 | 0 | — | 1 | 287 |
| 2018 | 0 | — | 0 | 320 |
| 2019 | 0 | — | 0 | 490 |
| 2020 | 3 | 106 | 1 | 643 |
| 2021 | 0 | — | 0 | 630 |
| 2022 | 0 | — | 0 | 589 |
| 2023 | 1 | — | 0 | 357 |
| 2024 | 3 | 146 | 0 | 466 |
| 2025 | 1 | — | 2 | 497 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Knee Fusion Nails are for intramedullary knee arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050938 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050938: Knee Fusion Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050938
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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