510(k) · Cleared
ClearedSmartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070
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 Dec 30, 2003 after a 76-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Dec 30, 2003
- Review
- 76 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK033317 Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750…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) | K033317 | Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff… | 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?
The Opus SmartStitch M-Connector is indicated for use for placement of Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.
The Opus SmartStitch Needle Cassette is indicated for use for placement of Braided Polyester Suture through soft tissue in endoscopic and other limited access 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/K033317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033317: Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033317
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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