510(k) · Cleared
ClearedMarionette SA, Model 001 001 & 001 002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetic Surgical, LLC · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 21, 2008 as substantially equivalent to K043541 (Novare Surgical Systems, Inc., 2005) and 2 other predicates after a 203-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Apr 21, 2008
- Review
- 203 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K910831 (1991). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK910831 Endopath Surgical InstrumentsSymbiosis Corp. · 1991
- 2 generations backK984240 Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. · 1999 · Recalled
- 1 generation backK043541 Endolink True Movement SystemNovare Surgical Systems, Inc. · 2005
- This deviceK072811 Marionette SA, Model 001 001 & 001 002Kinetic Surgical, LLC · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910831 | Endopath Surgical Instruments | Symbiosis Corp. | 1991 | — |
| −2 | K984240 | Endopath Endoscopic Instruments | Ethicon Endo-Surgery, Inc. | 1999 | 1 |
| −1 | K043541 | Endolink True Movement System | Novare Surgical Systems, Inc. | 2005 | — |
| 0 (this device) | K072811 | Marionette SA, Model 001 001 & 001 002 | Kinetic Surgical, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2006 | 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 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? (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 |
|---|---|---|---|
| * | K043541 | Endolink True Movement SystemSummary page 1…Grasper, Scissors, & Dissector Regulatory Class: Class II Predicate Device: Endolink True Movement system (K043541) Microline Incorporated Re-New Laparoscopic Instruments (K962119)… | 2005 |
| * | K962119 | RE-New Laparoscopic InstrumentsSummary page 1…vement system (K043541) Microline Incorporated Re-New Laparoscopic Instruments (K962119) Cambridge Laparo-Angle (K061425) Intended Use: The… | 1996 |
| * | K061425 | Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model PW1201-01;Purewrist Hook…Summary page 1…Incorporated Re-New Laparoscopic Instruments (K962119) Cambridge Laparo-Angle (K061425) Intended Use: The Marionette T M SA is intended for use by surgeons for grasping,… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 2 other devices also cite its predicate K043541.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 MarionetteTM SA is intended for use by surgeons for grasping, dissection, tissue cutting during laparoscopic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072811 · printed Nov 3, 2026
Cite this page
510(k) Report. “K072811: Marionette SA, Model 001 001 & 001 002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K072811
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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