510(k) · Cleared
ClearedModified Spacemaker System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 24, 2004 after a 17-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Sep 24, 2004
- Review
- 17 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 4 citing it directly.
- This deviceK042412 Modified Spacemaker SystemUnited States Surgical, A Division of Tyco Healthc · 2004
- Descendant · cites it directly · 9 of its ownK090631 Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie · 2009
- Descendant · cites it directly · 7 of its ownK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
- Descendant · 2 generations on · 6 of its ownK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K090631Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie · 2009 · cites it directly9descendants
- K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010 · cites it directly7descendants
- K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · 2 generations on6descendants
- K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · 3 generations on5descendants
- K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042412 | Modified Spacemaker System | United States Surgical, A Division of Tyco Healthc | 2004 | — |
| +1 | K090631 | Pajunk Disposable Balloons and Balloon Systems | PAJUNK GmbH Medizintechnologie | 2009 | — |
| +1 | K092726 | Mesh GPS - Large, Small, SM, SM Small | Surgical Structures, Ltd. | 2010 | — |
| +2 | K102766 | Composix L/P Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2010 | 2 |
| +3 | K110820 | Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System | C.R. Bard, Inc. | 2011 | — |
| +3 | K122436 | Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with… | C.R. Bard, Inc. | 2012 | 15 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | — | Auto Suture* Dissection Balloon Named without a submission number | |
| * | — | Auto Suture* Blunt Tip Trocar Named without a submission number | |
| * | — | Auto Suture* Structural Balloon Trocar Named without a submission number |
What descends from it? (12)
See all 124 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?
- Of its descendants, K090631 (PAJUNK GmbH Medizintechnologie, 2009) has gone furthest, with 9 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.
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 Modified SPACEMAKER* System: SPACEMAKER* Structural Balloon Trocar The SPACEMAKER* Structural Balloon Trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or…
Read the full statement (121 words)
The Modified SPACEMAKER* System:
SPACEMAKER* Structural Balloon Trocar
The SPACEMAKER* Structural Balloon Trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures.
SPACEMAKER* Blunt Tip Trocar
The SPACEMAKER* Blunt Tip Trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.
SPACEMAKER* Dissection Balloon
The SPACEMAKER* Dissection Balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042412: Modified Spacemaker System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042412
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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