510(k) Report

510(k) · Cleared

Cleared

Soft Tissue Anchoring Washers

K030031510(k) TraditionalCleared Jan 28, 200325-day reviewClass I21 CFR 878.4930

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

Accu-Speed, Incorporated · KGS Retention Device, Suture

Cleared on Jan 28, 2003 after a 25-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jan 28, 2003
Review
25 days
Class
Class I
Product code
KGS
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K030031Source: FDA 510(k) database · 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

How does its category compare?

All KGS devices

KGS Retention Device, Suture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGS

FDA has decided no KGS device since 2007.

Median 510(k) review, days · KGS

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

Recalls per year · KGS

No recall names KGS since 2007.

Adverse event reports per year · KGS

3in 2025

2007: 262008: 152009: 62010: 12011: 12012: 42013: 62014: 22015: 12016: 12017: 42019: 12020: 32021: 12023: 112024: 22025: 3
2007high 26 (2007) · low 0 (2018)2025

MAUDE reports naming product code KGS, 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
20070—026
20080—015
20090—06
20100—01
20110—01
20120—04
20130—06
20140—02
20150—01
20160—01
20170—04
20180—00
20190—01
20200—03
20210—01
20220—00
20230—011
20240—02
20250—03
20260—0—

What is it indicated for?

The Soft Tissue Anchoring Washers [washers], [washer, bolt nut] are to be used for anchoring soft tissue to bone.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in KGS

The KGS category page

  • K020480RBMSmith & Nephew, Inc. · 20021 recall
  • K964935Suture LockSmith & Nephew Endoscopy, Inc. · 1997
  • K941740Acufex Rotator Cuff Fixation ButtonAcufex Microsurgical, Inc. · 1995
  • K930675Mitek Cone WasherMitek Surgical Products, Inc. · 1993
  • K904435Ventrofil Tension Relief Suture SetAesculap, Inc. · 1991

https://510kreport.com/device/K030031 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030031: Soft Tissue Anchoring Washers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030031

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026