510(k) · Cleared
ClearedArthrex Synergy UHD4 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Feb 12, 2016 as substantially equivalent to K071756 (Pointe Conception Medical, Inc., 2007) after a 99-day review. Its family tree reaches back 4 generations to 1995. 14 later devices descend from it.
- Decided
- Feb 12, 2016
- Review
- 99 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950862 (1995). 5 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
- 3 generations backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
- 2 generations backK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
- 1 generation backK071756 Endohub- 1.0 Endoscopic Video Camera System with Video CapturePointe Conception Medical, Inc. · 2007
- This deviceK153218 Arthrex Synergy UHD4 SystemArthrex, Inc. · 2016
- Descendant · cites it directly · 12 of its ownK190645 Arthrex NanoScope SystemArthrex, Inc. · 2019
- Descendant · 2 generations on · 11 of its ownK201134 Arthrex NanoScope SystemArthrex, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK202582 Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK243008 Arthrex NanoScope SystemArthrex, Inc. · 2025
- Descendant · 2 generations on · 4 of its ownK223759 Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K190645Arthrex NanoScope SystemArthrex, Inc. · 2019 · cites it directly12descendants
- K201134Arthrex NanoScope SystemArthrex, Inc. · 2020 · 2 generations on11descendants
- K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc. · 2021 · cites it directly5descendants
- K243008Arthrex NanoScope SystemArthrex, Inc. · 2025 · 3 generations on4descendants
- K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color… | Karl Storz Imaging, Inc. | 1995 | — |
| −3 | K983566 | 3-Chip Video Camera | Stryker Endoscopy | 1999 | 1 |
| −2 | K031098 | 3-CCD Digital Camera System | Linvatec Corp. | 2003 | — |
| −1 | K071756 | Endohub- 1.0 Endoscopic Video Camera System with Video Capture | Pointe Conception Medical, Inc. | 2007 | — |
| 0 (this device) | K153218 | Arthrex Synergy UHD4 System | Arthrex, Inc. | 2016 | — |
| +1 | K190645 | Arthrex NanoScope System | Arthrex, Inc. | 2019 | — |
| +2 | K201134 | Arthrex NanoScope System | Arthrex, Inc. | 2020 | — |
| +1 | K202582 | Arthrex SynergyID Endoscopic Imaging System | Arthrex, Inc. | 2021 | — |
| +3 | K243008 | Arthrex NanoScope System | Arthrex, Inc. | 2025 | — |
| +2 | K223759 | Arthrex SynergyID Endoscopic Imaging System | Arthex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K071756 | Endohub- 1.0 Endoscopic Video Camera System with Video CaptureSummary page 4…GCJ Classification Name, CFR 21 CFR 876.1500: Endoscope and accessories Predicate Device K071756: Endohub-1.0 Endoscopic Video Camera with Video Capture Purpose of Submission This Special 510(k) p… | 2007 |
What descends from it? (14)
See all 142 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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K190645 (Arthrex, Inc., 2019) has gone furthest, with 12 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The Arthrex Synergy UHD4 System is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.
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/K153218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153218: Arthrex Synergy UHD4 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153218
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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