510(k) Report

510(k) · Cleared

Cleared

Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures)

K013059510(k) TraditionalCleared Oct 22, 200141-day reviewClass II21 CFR 878.4495

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

Stony Brook Surgical Innovations, Inc. · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Cleared on Oct 22, 2001 as substantially equivalent to K931271 (ETHICON, Inc., 1994) after a 41-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it.

Decided
Oct 22, 2001
Review
41 days
Class
Class II
Product code
GAQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K931271 (1994). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2011: 1 descendant cleared2007: 1 descendant cleared2003: 1 descendant cleared2020: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant clearedK931271 · Ethi-Pack* Surgical Stainless Steel Suture · ETHICON, Inc. · 19941990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K931271 · Ethi-Pack* Surgical Stainless Steel Suture · ETHICON, Inc. · 19940
  1. Root · 1 generation backK931271 Ethi-Pack* Surgical Stainless Steel SutureETHICON, Inc. · 1994
  2. This deviceK013059 Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures)Stony Brook Surgical Innovations, Inc. · 2001
  3. Descendant · cites it directly · 4 of its ownK023411 Steelex Sternum SetAesculap, Inc. · 2002
  4. Descendant · cites it directly · 1 of its ownK110039 Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine · 2011
  5. Descendant · 2 generations on · 1 of its ownK063603 Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15…Suturtek Incorporated · 2007
  6. Descendant · 2 generations on · 1 of its ownK032468 Suturtek Fastclose Sternum Closure DeviceSuturtek Incorporated · 2003
  7. Descendant · 2 generations on · 0 of its ownK191030 Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™…Life Technologies Corporation · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12007: 12008: 12009: 12011: 12020: 1
2002high 1 (2002) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all
  • K023411Steelex Sternum SetAesculap, Inc. · 2002 · cites it directly4descendants
  • K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine · 2011 · cites it directly1descendant
  • K063603Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Suturtek Incorporated · 2007 · 2 generations on1descendant
  • K032468Suturtek Fastclose Sternum Closure DeviceSuturtek Incorporated · 2003 · 2 generations on1descendant
  • K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K931271Ethi-Pack* Surgical Stainless Steel SutureETHICON, Inc.1994—
0 (this device)K013059Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures)Stony Brook Surgical Innovations, Inc.2001—
+1K023411Steelex Sternum SetAesculap, Inc.2002—
+1K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine2011—
+2K063603Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Suturtek Incorporated2007—
+2K032468Suturtek Fastclose Sternum Closure DeviceSuturtek Incorporated2003—
+2K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx…Life Technologies Corporation2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200710
200810
200910
201110
202010
FIG. 1 — Lineage of K013059, 1994–2020Source: 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 GAQ? 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 GAQ device

  1. #1 K203855 CoNextions TR Tendon Repair Systemscore 3.8 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K931271Ethi-Pack* Surgical Stainless Steel Suture
Summary page 1
…Brook Surgical Innovations Sterna-Wire (Sternal Sutures) 3. Predicate Device Information: Ethi-Pack™ Surgical Stainless Steel Suture, Ethicon, Inc., Somerville, NJ, K#931271 4. Device Description: Sterna-Wire is indicated for use in the Sternal Closure. Sterna-Wire is a non absorbable sterile surgica…
ETHICON, Inc.1994—

Also cleared against K931271: 18 other devices →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023411Steelex Sternum SetAesculap, Inc.20024
K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine20111

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, K023411 (Aesculap, Inc., 2002) has gone furthest, with 4 descendants of its own.
  • 18 other devices also cite its predicate K931271.

How does its category compare?

All GAQ devices

GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAQ

1in 2022

2007: 12008: 22014: 22017: 12018: 12020: 12022: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAQ

Too few GAQ 510(k)s in any year since 2007 to give a median.

Recalls per year · GAQ

2so far in 2026, the most since 2007

2026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

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

Adverse event reports per year · GAQ

83in 2025

2007: 72008: 42009: 72010: 132011: 192012: 102013: 162014: 182015: 172016: 232017: 112018: 532019: 762020: 522021: 392022: 702023: 1002024: 1762025: 83
2007high 176 (2024) · low 4 (2008)2025

MAUDE reports naming product code GAQ, 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
20071—07
20082—04
20090—07
20100—013
20110—019
20120—010
20130—016
20142—018
20150—017
20160—023
20171—011
20181—053
20190—076
20201—052
20210—039
20221—070
20230—0100
20240—0176
20250—083
20260—2—

What is it indicated for?

The Stony Brook Surgical Innovations’ (SBSI) Sterna-Wire is a non-absorbable Stainless Steel Wire with an attached needle that is used during thoracic surgery to close and hold the stemum after a median sternotomy. The Sterna-Wire remains in the Sternum indefinitely and is not removed.

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 K931271

18 other devices cite the same predicate.

  • K173579Thorecon™ Fixation SystemA & E Medical Corporation · 2018
  • K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
  • K142484Sternal Closure SystemJace Medical, LLC · 2014
  • K141007Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp. · 2014
  • K120016Pioneer Sternal Assist Implant SystemPioneer Surgical Technology, Inc. · 2012
  • K120177Spinal Elements Cerclage SystemSpinal Elements, Inc. · 2012

More from Stony Brook Surgical Innovations, Inc.

2 FDA decisions under this applicant name. See the company

  • K930015Sternal BandStony Brook Surgical Innovations, Inc. · 1993

Recent decisions in GAQ

The GAQ category page

  • K203855CoNextions TR Tendon Repair SystemConextions Medical · 2022
  • K193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd. · 2020
  • K172146MeristeelM/s. Meril Endo Surgery Private Limited. · 2018
  • K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc. · 2017
  • K141007Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp. · 2014

https://510kreport.com/device/K013059 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013059: Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013059

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026