510(k) · Cleared
ClearedSmartstitch M-Connector, Model OM-8005; Smartstitch Actuation Handle, Model OM-8500; and Smartstitch Suture Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opus Medical, Inc. · OCW Endoscopic Tissue Approximation Device
Cleared on Feb 14, 2003 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Feb 14, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK023843 Smartstitch M-Connector, Model OM-8005; Smartstitch Actuation…Opus Medical, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK121306 Smartstitch M-Connector Ultra Smartstitch Suture Device Handle…Arthocare Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK163142 SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White…ArthroCare Corporation · 2017 · Recalled
Most influential descendants
Showing 2 of 2 · See all- K121306Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device…Arthocare Corporation · 2012 · cites it directly1descendant
- K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid…ArthroCare Corporation · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023843 | Smartstitch M-Connector, Model OM-8005; Smartstitch Actuation Handle, Model… | Opus Medical, Inc. | 2003 | — |
| +1 | K121306 | Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch… | Arthocare Corporation | 2012 | — |
| +2 | K163142 | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue… | ArthroCare Corporation | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OCW? 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 OCW device
- #1 K252400 Endomina EZFuse systemscore 12.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121306 | Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device… | 2012 | 1 |
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, K121306 (Arthocare Corporation, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
SmartStitch Suture Device:
The Opus SmartStitch M-Connector (Model #0M-8005) is indicated for use with a Actuation Handle (Model #0M-8500) and Suture Cartridges (Models #OM-8051, -8052, -8053) for placement of #2 Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.
SmartStitch Sutures:
The Opus Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, orthopedic, and neurological procedures.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K023843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023843: Smartstitch M-Connector, Model OM-8005; Smartstitch Actuation Handle, Model OM-8500; and Smartstitch Suture Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023843
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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