510(k) Report

510(k) · Cleared

Cleared

Ogden Anchor

K950875510(k) TraditionalCleared Jul 11, 1995133-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

American Medical Electronics, Inc. · HWC Screw, Fixation, Bone

Cleared on Jul 11, 1995 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 167 later devices descend from it.

Decided
Jul 11, 1995
Review
133 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 2 descendants cleared2002: 4 descendants cleared2003: 1 descendant cleared2004: 2 descendants cleared2006: 3 descendants cleared1999: 2 descendants cleared2007: 2 descendants cleared2008: 3 descendants cleared2005: 1 descendant cleared2009: 6 descendants cleared2010: 4 descendants cleared2011: 5 descendants cleared2025: 23 descendants cleared2024: 16 descendants cleared2012: 4 descendants cleared2015: 5 descendants cleared2013: 5 descendants cleared2017: 7 descendants cleared2018: 4 descendants cleared2023: 18 descendants cleared2019: 6 descendants cleared2026: 14 descendants cleared2022: 8 descendants cleared2016: 3 descendants cleared2014: 7 descendants cleared2020: 5 descendants cleared2021: 7 descendants cleared1995200020052010201520202025
  1. This deviceK950875 Ogden AnchorAmerican Medical Electronics, Inc. · 1995
  2. Descendant · cites it directly · 166 of its ownK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
  3. Descendant · 2 generations on · 86 of its ownK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
  4. Descendant · 3 generations on · 79 of its ownK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
  5. Descendant · 2 generations on · 78 of its ownK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
  6. Descendant · 2 generations on · 77 of its ownK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003

Showing 5 of 167 descendants. See all descendants

Descendants cleared per year

1998: 21999: 22002: 42003: 12004: 22005: 12006: 32007: 22008: 32009: 62010: 42011: 52012: 42013: 52014: 72015: 52016: 32017: 72018: 42019: 62020: 52021: 72022: 82023: 182024: 162025: 232026: 14
1998high 23 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 167 · See all
  • K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998 · cites it directly166descendants
  • K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998 · 2 generations on86descendants
  • K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999 · 3 generations on79descendants
  • K020056Duet Suture AnchorBionx Implants, Ltd. · 2002 · 2 generations on78descendants
  • K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003 · 2 generations on77descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950875Ogden AnchorAmerican Medical Electronics, Inc.1995—
+1K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc.1998—
+2K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.1998—
+3K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments1999—
+2K020056Duet Suture AnchorBionx Implants, Ltd.2002—
+2K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199920
200240
200310
200420
200510
200630
200720
200830
200960
201040
201150
201240
201350
201470
201550
201630
201770
201840
201960
202050
202170
202280
2023180
2024160
2025230
2026140
FIG. 1 — Lineage of K950875, 1995–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (167)

See all 167

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

NumberDeviceApplicantDecidedDescendants
K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc.1998166

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, K972783 (Bionx Implants, Inc., 1998) has gone furthest, with 166 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—

More from American Medical Electronics, Inc.

14 FDA decisions under this applicant name. See the company

  • K951232Expanded Range of Suture Sizes Ogden Anchors: 7.4MM and 5.5MMAmerican Medical Electronics, Inc. · 1995
  • K952348Ogden AnchorAmerican Medical Electronics, Inc. · 1995
  • K951493Ogden AnchorAmerican Medical Electronics, Inc. · 1995
  • K951545Ogden Anchor for All Orthopaedic Soft Tissue ApplicationsAmerican Medical Electronics, Inc. · 1995
  • K941029Ogden Anchor-Small (Tentative)American Medical Electronics, Inc. · 1995

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K950875 · printed Nov 5, 2026

Cite this page

510(k) Report. “K950875: Ogden Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950875

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026