510(k) Report

510(k) · Cleared

Cleared

Surgical Dynamics Ogden Suture Anchor with Suture

K020352510(k) SpecialCleared Feb 26, 200222-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

Unitedstates Surgical · HWC Screw, Fixation, Bone

Cleared on Feb 26, 2002 after a 22-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.

Decided
Feb 26, 2002
Review
22 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2007: 1 descendant cleared2020: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2011: 1 descendant cleared2014: 2 descendants cleared2015: 1 descendant cleared200020052010201520202025
  1. This deviceK020352 Surgical Dynamics Ogden Suture Anchor with SutureUnitedstates Surgical · 2002
  2. Descendant · cites it directly · 8 of its ownK040594 Herculon Soft Tissue Reattachment SystemUnited States Surgical, A Division of Tyco Healthc · 2004
  3. Descendant · 2 generations on · 7 of its ownK071520 Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
  4. Descendant · 3 generations on · 3 of its ownK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
  5. Descendant · 4 generations on · 1 of its ownK140127 Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014
  6. Descendant · 3 generations on · 1 of its ownK090128 Tac-Tite (TM)Core Essence Orthopaedics, Inc. · 2009

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2004: 12007: 12009: 12010: 12011: 12014: 22015: 12020: 1
2004high 2 (2014) · low 0 (2005)2026

Most influential descendants

Showing 5 of 9 · See all
  • K040594Herculon Soft Tissue Reattachment SystemUnited States Surgical, A Division of Tyco Healthc · 2004 · cites it directly8descendants
  • K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007 · 2 generations on7descendants
  • K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010 · 3 generations on3descendants
  • K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014 · 4 generations on1descendant
  • K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc. · 2009 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020352Surgical Dynamics Ogden Suture Anchor with SutureUnitedstates Surgical2002—
+1K040594Herculon Soft Tissue Reattachment SystemUnited States Surgical, A Division of Tyco Healthc2004—
+2K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC2007—
+3K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.2010—
+4K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC2014—
+3K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
200910
201010
201110
201420
201510
202010
FIG. 1 — Lineage of K020352, 2002–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*—Surgical Dynamics Ogden Suture Anchor with Suture
Named without a submission number
—

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K040594Herculon Soft Tissue Reattachment SystemUnited States Surgical, A Division of Tyco Healthc20048

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?

  • Of its descendants, K040594 (United States Surgical, A Division of Tyco Healthc, 2004) has gone furthest, with 8 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 Surgical Dynamics Ogden Suture Anchor with Suture is intended for the reapproximation of soft tissue.

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

More from Unitedstates Surgical

2 FDA decisions under this applicant name. See the company

  • K021825Modification to Spiral Radius 90-D SST SystemUnitedstates Surgical · 2002

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K020352 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020352: Surgical Dynamics Ogden Suture Anchor with Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020352

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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