510(k) · Cleared
ClearedOpus Smartstich Suture Device with Perfectpasser Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · OCW Endoscopic Tissue Approximation Device
Cleared on Oct 2, 2006 as substantially equivalent to K030170 (Opus Medical, Inc., 2003) after a 60-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- Oct 2, 2006
- Review
- 60 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030170 (2003). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK030170 Reusable Smartstitch Suture Device, Models OM-8007, OM-8500Opus Medical, Inc. · 2003
- This deviceK062244 Opus Smartstich Suture Device with Perfectpasser ConnectorArthrocare Corp. · 2006
- 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
- Descendant · cites it directly · 0 of its ownK070671 Opus Smartstitch Suture DeviceArthrocare Corp. · 2007 · Recalled
Most influential descendants
Showing 3 of 3 · 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
- K070671Opus Smartstitch Suture DeviceArthrocare Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030170 | Reusable Smartstitch Suture Device, Models OM-8007, OM-8500 | Opus Medical, Inc. | 2003 | — |
| 0 (this device) | K062244 | Opus Smartstich Suture Device with Perfectpasser Connector | Arthrocare Corp. | 2006 | — |
| +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 |
| +1 | K070671 | Opus Smartstitch Suture Device | Arthrocare Corp. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 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 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? (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 |
|---|---|---|---|
| * | K030170 | Reusable Smartstitch Suture Device, Models OM-8007, OM-8500Summary page 1…ccessories (Class II per 21 CFR 876.1 500) Product Code: KOG Predicate Device Opus SmartStitch Suture Device K030 170 (Cleared 07/28/03) Product Description The Opus aSmartStitchTMSuture Device with PerfectPasser"M Connector is designed to allow… | 2003 |
What descends from it? (3)
2 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?
- Its one ancestor has no recall.
- 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™ Suture Device with PerfectPasser™ Connector is indicated for use for placement of braided polyester and polyethylene suture through soft tissue in endoscopic and other limited access procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062244 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062244: Opus Smartstich Suture Device with Perfectpasser Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062244
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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