510(k) Report

510(k) · Cleared

Cleared

Capsew Plication System

K071796510(k) TraditionalCleared Oct 19, 2007109-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

Cayenne Medical, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Oct 19, 2007 as substantially equivalent to K042031 (Opus Medical, Inc., 2004) and 3 other predicates after a 109-day review. Its family tree reaches back 4 generations to 1999.

Decided
Oct 19, 2007
Review
109 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K990088 (1999). 16 ancestors in all, the oldest K954808 (1996). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2004: 3 other ancestors2000: 3 other ancestors2005: 1 other ancestor2001: 3 other ancestors1996: 1 other ancestorK990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 1999K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 2002K041894 · Orthofiber · Cp Medical · 20041996199820002002200420062008
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 4 other ancestors K041894 · Orthofiber · Cp Medical · 2004K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 2002K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 19990
  1. Root · 4 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
  2. 3 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
  3. 2 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
  4. 1 generation backK041894 OrthofiberCp Medical · 2004
  5. This deviceK071796 Capsew Plication SystemCayenne Medical, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K990088Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc.1999—
−3K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc.2001—
−2K021434Arthrex Fiberwire in Usp SizesArthrex, Inc.2002—
−1K041894OrthofiberCp Medical2004—
0 (this device)K071796Capsew Plication SystemCayenne Medical, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200030
200130
200430
200510
200710
FIG. 1 — Lineage of K071796, 1999–2007Source: 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? (4)

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
*K042031Opus Speedstitch Suture Device
Summary page 2
…redicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Opus Medical, Inc.'s Opus SpeedStitchTM Suture Device (K042031), CP Medical's CP Fiber, Non-Absorbable Polyblend Surgical Suture (K041894), Teleflex Medical's Force Fiber Polyethylene Non-Abso…
Opus Medical, Inc.20041
*K041894Orthofiber
Summary page 2
…lly equivalent to preamendment devices: Opus Medical, Inc.'s Opus SpeedStitchTM Suture Device (K042031), CP Medical's CP Fiber, Non-Absorbable Polyblend Surgical Suture (K041894), Teleflex Medical's Force Fiber Polyethylene Non-Absorbable Surgical Suture (K063778), and Genzyme Surgical Products Polyester N…
Cp Medical2004—
*K063778Force Fiber Polyethylene Nonabsorbable Suture
Summary page 2
…Device (K042031), CP Medical's CP Fiber, Non-Absorbable Polyblend Surgical Suture (K041894), Teleflex Medical's Force Fiber Polyethylene Non-Absorbable Surgical Suture (K063778), and Genzyme Surgical Products Polyester Nonabsorbable Surgical Suture (K001434).…
Teleflex Medical20071
*K001434'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture
Summary page 2
…e (K041894), Teleflex Medical's Force Fiber Polyethylene Non-Absorbable Surgical Suture (K063778), and Genzyme Surgical Products Polyester Nonabsorbable Surgical Suture (K001434). Revised page 18 of 176…
Genzyme Surgical Product (Genzyme Biosurgery)20001

Also cleared against K042031: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 8 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
  • 6 of the 16 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K042031.

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. 2007, 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 CapSew Plication System is intended for use in placement of suture through soft tissue in arthroscopic and open surgical procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K042031

2 other devices cite the same predicate.

  • K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed…ArthroCare Corporation · 20171 recall
  • K061386Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006

More from Cayenne Medical, Inc.

22 FDA decisions under this applicant name. See the company

  • K180274Ventix Link Knotless Anchor with InserterCayenne Medical, Inc. · 2018
  • K172186BioWick X Implant with DriverCayenne Medical, Inc. · 2017
  • K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. · 2016
  • K151068SureLock W Suture AnchorCayenne Medical, Inc. · 2015
  • K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock…Cayenne Medical, Inc. · 2015

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/K071796 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071796: Capsew Plication System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071796

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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