510(k) Report

510(k) · Cleared

Cleared

Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device Handle

K121306510(k) TraditionalCleared Jul 12, 201272-day reviewClass II21 CFR 878.5000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthocare Corporation · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Jul 12, 2012 as substantially equivalent to K023843 (Opus Medical, Inc., 2003) and 2 other predicates after a 72-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.

Decided
Jul 12, 2012
Review
72 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K030170 (2003). 4 ancestors in all, the oldest K023843 (2003). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2017: 1 descendant clearedK030170 · Reusable Smartstitch Suture Device, Models OM-8007, OM-8500 · Opus Medical, Inc. · 2003K062244 · Opus Smartstich Suture Device with Perfectpasser Connector · Arthrocare Corp. · 2006200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K062244 · Opus Smartstich Suture Device with Perfectpasser Connector · Arthrocare Corp. · 2006K030170 · Reusable Smartstitch Suture Device, Models OM-8007, OM-8500 · Opus Medical, Inc. · 20030
  1. Root · 2 generations backK030170 Reusable Smartstitch Suture Device, Models OM-8007, OM-8500Opus Medical, Inc. · 2003
  2. 1 generation backK062244 Opus Smartstich Suture Device with Perfectpasser ConnectorArthrocare Corp. · 2006
  3. This deviceK121306 Smartstitch M-Connector Ultra Smartstitch Suture Device Handle…Arthocare Corporation · 2012
  4. Descendant · cites it directly · 0 of its ownK163142 SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White…ArthroCare Corporation · 2017 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid…ArthroCare Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K030170Reusable Smartstitch Suture Device, Models OM-8007, OM-8500Opus Medical, Inc.2003—
−1K062244Opus Smartstich Suture Device with Perfectpasser ConnectorArthrocare Corp.2006—
0 (this device)K121306Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch…Arthocare Corporation2012—
+1K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue…ArthroCare Corporation20171

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K121306, 2003–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K023843Smartstitch M-Connector, Model OM-8005; Smartstitch Actuation Handle, Model OM-8500; and…
Summary page 1
…on: 21 CFR 878.5000 Predicate Device The SmartStitch M-Connector Ultra System is substantially equivalent to the ArthroCare M- Connector System cleared under K023843 (February 14, 2003) and K033317 (December 30, 2003), to the ArthroCare PerfectPasser® Connector System cleared under K(062244 (Oc…
Opus Medical, Inc.2003—
*K033317Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System…
Summary page 1
…Predicate Device The SmartStitch M-Connector Ultra System is substantially equivalent to the ArthroCare M- Connector System cleared under K023843 (February 14, 2003) and K033317 (December 30, 2003), to the ArthroCare PerfectPasser® Connector System cleared under K(062244 (October 2, 2006). Description The…
Opus Medical, Inc.2003—
*K062244Opus Smartstich Suture Device with Perfectpasser Connector
Summary page 1
…throCare M- Connector System cleared under K023843 (February 14, 2003) and K033317 (December 30, 2003), to the ArthroCare PerfectPasser® Connector System cleared under K(062244 (October 2, 2006). Description The SmartStitch M-Connector Ultra System is an orthopedic/arthroscopic instrument for mechanicall…
Arthrocare Corp.2006—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid…ArthroCare Corporation20170

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?

  • The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K163142 (ArthroCare Corporation, 2017) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GAT devices

GAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · GAT

5in 2025

2007: 62008: 42009: 92010: 112011: 12012: 62013: 42014: 42015: 72016: 102017: 62018: 62019: 42020: 52021: 42022: 52023: 82024: 32025: 52026 (partial year): 5
2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007: 40 days median2008: 93 days median2009: 57 days median2010: 27 days median2012: 61 days median2013: 123 days median2014: 45 days median2015: 125 days median2016: 139 days median2017: 57 days median2018: 95 days median2019: 79 days median2020: 201 days median2021: 92 days median2022: 109 days median2023: 220 days median2024: 140 days median2025: 30 days median2026 (partial year): 83 days median
2007high 220 (2023) · low 27 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GAT

1in 2011

2007: 12010: 32011: 1
2007high 3 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAT

2,956in 2025

2007: 152008: 152009: 552010: 792011: 972012: 2532013: 2102014: 1652015: 6262016: 6882017: 1,1042018: 1,4532019: 1,2512020: 1,2202021: 1,6432022: 1,4192023: 2,0382024: 2,5972025: 2,956
2007high 2,956 (2025) · low 15 (2007)2025

MAUDE reports naming product code GAT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007640115
2008493015
2009957055
20101127379
20111—197
20126610253
201341230210
20144450165
201571250626
2016101390688
201765701,104
201869501,453
201947901,251
2020520101,220
202149201,643
2022510901,419
2023822002,038
2024314002,597
202553002,956
20265830—

What is it indicated for?

The SmartStitch® M-Connector Ultra System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.

Indications for use as stated in the FDA summary.

More from Arthocare Corporation

6 FDA decisions under this applicant name. See the company

  • K153669MultiFIX S Ultra Knotless Fixation SystemArthocare Corporation · 2016
  • K131182Multifix S Knotless Fixation DeviceArthocare Corporation · 2013
  • K120791Ambient Turboflash 90 IfsArthocare Corporation · 2012
  • K123268Smartstitch Perfectpasser SystemArthocare Corporation · 20121 recall
  • K013334EndoflipArthocare Corporation · 2001

Recent decisions in GAT

The GAT category page

  • K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026
  • K261021EasyWhip FamilyWinter Innovations, Inc. · 2026
  • K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026
  • K254275HyperSuture All Green Extension LineThreadstone, LLC · 2026
  • K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026

https://510kreport.com/device/K121306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121306: Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device Handle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121306

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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