510(k) · Cleared
ClearedStainless Steel Soft Suture Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bregma International Trading Company, Ltd. · LRN Wire, Surgical
Cleared on Jul 8, 1999 after a 153-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 8, 1999
- Review
- 153 days
- Class
- Class II
- Product code
- LRN
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
Planning a device in LRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 LRN devicesLRN Wire, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRN
FDA has decided no LRN device since 2007.
Median 510(k) review, days · LRN
Too few LRN 510(k)s in any year since 2007 to give a median.
Recalls per year · LRN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRN
81in 2025
MAUDE reports naming product code LRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 20 |
| 2009 | 0 | — | 0 | 31 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 108 |
| 2014 | 0 | — | 0 | 57 |
| 2015 | 0 | — | 0 | 24 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 0 | — | 1 | 84 |
| 2020 | 0 | — | 0 | 68 |
| 2021 | 0 | — | 0 | 118 |
| 2022 | 0 | — | 0 | 106 |
| 2023 | 0 | — | 0 | 140 |
| 2024 | 0 | — | 0 | 87 |
| 2025 | 0 | — | 0 | 81 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stainless Steel Soft Suture Wire is intended for general orthopedic surgery such as sternum closure, fracture fixation of long boneg, and patella fracture fixation. The device is also intended for: soft tissue approximation such as abdomina! wound closure and hernia repair.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990355: Stainless Steel Soft Suture Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990355
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026