510(k) Report

510(k) · Cleared

Cleared

Herculon Soft Tissue Reattachment System

K040594510(k) SpecialCleared Mar 31, 200423-day reviewClass II21 CFR 888.3040

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

United States Surgical, A Division of Tyco Healthc · HWC Screw, Fixation, Bone

Cleared on Mar 31, 2004 as substantially equivalent to K020352 (Unitedstates Surgical, 2002) after a 23-day review. Its family tree reaches back 1 generation to 2002. 8 later devices descend from it.

Decided
Mar 31, 2004
Review
23 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K020352 (2002). 8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2020: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2011: 1 descendant cleared2014: 2 descendants cleared2015: 1 descendant clearedK020352 · Surgical Dynamics Ogden Suture Anchor with Suture · Unitedstates Surgical · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K020352 · Surgical Dynamics Ogden Suture Anchor with Suture · Unitedstates Surgical · 20020
  1. Root · 1 generation backK020352 Surgical Dynamics Ogden Suture Anchor with SutureUnitedstates Surgical · 2002
  2. This deviceK040594 Herculon Soft Tissue Reattachment SystemUnited States Surgical, A Division of Tyco Healthc · 2004
  3. Descendant · cites it directly · 7 of its ownK071520 Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
  4. Descendant · 2 generations on · 3 of its ownK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
  5. Descendant · 3 generations on · 1 of its ownK140127 Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014
  6. Descendant · 2 generations on · 1 of its ownK090128 Tac-Tite (TM)Core Essence Orthopaedics, Inc. · 2009
  7. Descendant · 2 generations on · 0 of its ownK193377 TopLock Anchor SystemFusion Orthopedics, LLC · 2020

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12010: 12011: 12014: 22015: 12020: 1
2007high 2 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 8 · See all
  • K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007 · cites it directly7descendants
  • K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010 · 2 generations on3descendants
  • K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014 · 3 generations on1descendant
  • K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc. · 2009 · 2 generations on1descendant
  • K193377TopLock Anchor SystemFusion Orthopedics, LLC · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K020352Surgical Dynamics Ogden Suture Anchor with SutureUnitedstates Surgical2002—
0 (this device)K040594Herculon Soft Tissue Reattachment SystemUnited States Surgical, A Division of Tyco Healthc2004—
+1K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC2007—
+2K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.2010—
+3K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC2014—
+2K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc.2009—
+2K193377TopLock Anchor SystemFusion Orthopedics, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201010
201110
201420
201510
202010
FIG. 1 — Lineage of K040594, 2002–2020Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (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
*K020352Surgical Dynamics Ogden Suture Anchor with Suture
Summary page 1
…ulon* Soft Tissue Reattachment System are comprised of materials which are in accordance with ISO Standard #10993-1. PREDICATE DEVICE Ogden* Suture Anchor with Suture (K020352) SUBSTANTIAL EQUIVALENCE- The Herculon* Soft Tissue Reattachment System was claimed to be substantially equivalent* to the curr…
Unitedstates Surgical2002—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC20077

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, K071520 (Core Essence Orthopaedics, LLC, 2007) has gone furthest, with 7 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Herculon* Soft Tissue Reattachment System is intended for the reapproximation of soft tissue. SHOULDER: Bankart, Slap lesion, Rotator cuff, and Deltoid repair. Acromio-clavicular separation, capsular shift/capsulolabral reconstruction and Biceps tenodesis. ELBOW: Tennis elbow repair, biceps tendon reattachment. KNEE: Extra capsular repairs; reattachment of medial and lateral collateral ligaments, posterior oblique ligament or joint capsule to tibia…

Read the full statement (95 words)

The Herculon* Soft Tissue Reattachment System is intended for the reapproximation of soft tissue.

SHOULDER: Bankart, Slap lesion, Rotator cuff, and Deltoid repair. Acromio-clavicular separation, capsular shift/capsulolabral reconstruction and Biceps tenodesis.

ELBOW: Tennis elbow repair, biceps tendon reattachment.

KNEE: Extra capsular repairs; reattachment of medial and lateral collateral ligaments, posterior oblique ligament or joint capsule to tibia, and joint capsule closure to anterior proximal tibia; Extra capsular reconstruction, ITB tenodesis, Patellar ligament and tendon avulsions.

ANKLE: Lateral and medial instability, Achilles tendon repair/reconstruction.

PELS: Fixation in pubic bone for the purpose of bladder neck suspension.

Indications for use as stated in the FDA summary.

More from United States Surgical, A Division of…

218 FDA decisions under this applicant name. See the company

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006

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https://510kreport.com/device/K040594 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040594: Herculon Soft Tissue Reattachment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040594

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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