510(k) · Cleared
Recalled · Class II · 2020SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ArthroCare Corporation · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Jan 6, 2017 as substantially equivalent to K042031 (Opus Medical, Inc., 2004) and 1 other predicate after a 58-day review. Its family tree reaches back 3 generations to 2003. It has been recalled once.
- Decided
- Jan 6, 2017
- Review
- 58 days
- Class
- Class II
- Product code
- GAT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K030170 (2003). 6 ancestors in all, the oldest K023843 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK030170 Reusable Smartstitch Suture Device, Models OM-8007, OM-8500Opus Medical, Inc. · 2003
- 2 generations backK062244 Opus Smartstich Suture Device with Perfectpasser ConnectorArthrocare Corp. · 2006
- 1 generation backK121306 Smartstitch M-Connector Ultra Smartstitch Suture Device Handle…Arthocare Corporation · 2012
- This deviceK163142 SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White…ArthroCare Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K030170 | Reusable Smartstitch Suture Device, Models OM-8007, OM-8500 | Opus Medical, Inc. | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K163142 | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue… | ArthroCare Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K042031 | Opus Speedstitch Suture DeviceSummary page 4…CFR Section: 21 CFR 878.5000 Predicate Device The SpeedStitch System is substantially equivalent to the following: SpeedStitch System (K042031, October 19, 2004) M-Connector Ultra System (K121306, July 12, 2012) CONFIDENTIAL… | 2004 |
| * | K121306 | Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device…Summary page 4…cate Device The SpeedStitch System is substantially equivalent to the following: SpeedStitch System (K042031, October 19, 2004) M-Connector Ultra System (K121306, July 12, 2012) CONFIDENTIAL Page i === Pa… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 17, 2020 | Class II | Z-2999-2020 | Mixed-up of materials/components | Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 2 other devices also cite its predicate K042031.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
The SpeedStitch System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163142: SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163142
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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