510(k) · Cleared
ClearedSynthes (Usa) Spherical Washers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · NDG Washer, Bolt, Nut, Non-Spinal, Metallic
Cleared on Nov 4, 2005 after a 56-day review. The FDA summary names its predicate without a number. 1 of the 197 devices in its family, counting itself, has a Class I recall. 196 later devices descend from it.
- Decided
- Nov 4, 2005
- Review
- 56 days
- Class
- Class II
- Product code
- NDG
- Recalls
- None
- Predicates
- 0
196 later devices descend from it, 9 citing it directly. 1 of the 197 devices in this family, counting this one, has a Class I recall.
- This deviceK052483 Synthes (Usa) Spherical WashersSynthes (Usa) · 2005
- Descendant · cites it directly · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 2 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
Showing 5 of 196 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 196 · See all- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · cites it directly161descendants
- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on79descendants
- K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 2 generations on74descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 3 generations on69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 4 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052483 | Synthes (Usa) Spherical Washers | Synthes (Usa) | 2005 | — |
| +1 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +2 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +2 | K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | 2017 | — |
| +3 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +4 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 8 | 0 |
| 2016 | 3 | 0 |
| 2017 | 12 | 0 |
| 2018 | 5 | 0 |
| 2019 | 9 | 0 |
| 2020 | 11 | 0 |
| 2021 | 14 | 1 |
| 2022 | 16 | 0 |
| 2023 | 22 | 0 |
| 2024 | 30 | 0 |
| 2025 | 25 | 0 |
| 2026 | 30 | 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.
1 device in this family has a Class I recall. 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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Synthes 13.0 mm Washer Named without a submission number |
What descends from it? (196)
See all 1969 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111994 | Smith & Nephew Cannulated Screws and Washers | 2011 | 161 |
| K133668 | Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate… | 2014 | 16 |
| K192745 | DePuy Synthes Trauma Screws | 2019 | 5 |
| K110086 | Ifs Profile Plates, Screws, and Washers | 2011 | 5 |
| K092754 | Sbi Foot and Ankle Cannulated Screw System, Model 100-0061 | 2010 | 4 |
| K130614 | Bone Fragment and Fixation Plates, Screws and Washers | 2014 | 2 |
| K160946 | 4.0 and 6.5 Cancellous Bone Screw and Washer | 2016 | 1 |
| K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist… | 2017 | 0 |
| K111008 | Microware Bone Plates and Bone Screw | 2012 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K111994 (Smith & Nephew, Inc., 2011) has gone furthest, with 161 descendants of its own.
How does its category compare?
All NDG devicesNDG Washer, Bolt, Nut, Non-Spinal, Metallic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NDG
FDA has decided no NDG device since 2007.
Median 510(k) review, days · NDG
Too few NDG 510(k)s in any year since 2007 to give a median.
Recalls per year · NDG
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDG
1in 2025
MAUDE reports naming product code NDG, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of large (long) bone and bone fragments.
In addition. the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052483: Synthes (Usa) Spherical Washers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052483
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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