510(k) · Cleared
ClearedDouble Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet & 3 Free Strands of Size #2-0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Apr 23, 2008 as substantially equivalent to K040004 (Depuy Mitek, 2004) and 3 other predicates after a 22-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Apr 23, 2008
- Review
- 22 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K990088 (1999). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 5 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 4 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- 3 generations backK032245 Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex…Arthrex, Inc. · 2004
- 2 generations backK041553 Arthrex Suture Grafting KitArthrex, Inc. · 2004
- 1 generation backK071622 Arthrex FiberwireArthrex, Inc. · 2007
- This deviceK080918 Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal…Depuy Mitek · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −5 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −4 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| −3 | K032245 | Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape… | Arthrex, Inc. | 2004 | — |
| −2 | K041553 | Arthrex Suture Grafting Kit | Arthrex, Inc. | 2004 | — |
| −1 | K071622 | Arthrex Fiberwire | Arthrex, Inc. | 2007 | — |
| 0 (this device) | K080918 | Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with… | Depuy Mitek | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
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 NEW? 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 NEW device
- #1 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue…score 15.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040004 | Orthocord Suture | 2004 |
| * | K043298 | Blue Orthocord SutureSummary page 1…Orthocord #2-0 suture is substantially equivalent to: Substantial Equivalence Orthocord #2 suture (KO40004, K043298) manufactured by Mitek; Mini QA+ I Minilok QA+ (K07 1622) manufactured by Mitek and… | 2004 |
| * | K071622 | Arthrex FiberwireSummary page 1…ial Equivalence Orthocord #2 suture (KO40004, K043298) manufactured by Mitek; Mini QA+ I Minilok QA+ (K07 1622) manufactured by Mitek and Fiberwire (K02 1434) manufactured by Arthrex Device Classification… | 2007 |
| * | K021434 | Arthrex Fiberwire in Usp SizesSummary page 1…043298) manufactured by Mitek; Mini QA+ I Minilok QA+ (K07 1622) manufactured by Mitek and Fiberwire (K02 1434) manufactured by Arthrex Device Classification Sutures, classified by the FDA, are Class 11 Medical Devices.… | 2002 |
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.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 17 ancestors have a recall of any class.
- 9 other devices also cite its predicate K040004.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NEW
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEW
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEW
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEW
2,504in 2025
MAUDE reports naming product code NEW, 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 | 2 | — | 0 | 7 |
| 2008 | 5 | 22 | 1 | 29 |
| 2009 | 0 | — | 4 | 42 |
| 2010 | 3 | 270 | 0 | 115 |
| 2011 | 1 | — | 0 | 59 |
| 2012 | 3 | 113 | 1 | 82 |
| 2013 | 5 | 32 | 1 | 185 |
| 2014 | 1 | — | 1 | 274 |
| 2015 | 2 | — | 0 | 280 |
| 2016 | 3 | 254 | 0 | 321 |
| 2017 | 1 | — | 0 | 461 |
| 2018 | 3 | 441 | 0 | 900 |
| 2019 | 4 | 144 | 2 | 1,122 |
| 2020 | 3 | 230 | 0 | 1,010 |
| 2021 | 1 | — | 0 | 1,466 |
| 2022 | 1 | — | 1 | 1,537 |
| 2023 | 1 | — | 0 | 1,975 |
| 2024 | 3 | 48 | 0 | 2,114 |
| 2025 | 6 | 146 | 0 | 2,504 |
| 2026 | 5 | 264 | 0 | — |
What is it indicated for?
Orthocord #2-0 suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080918: Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet & 3 Free Strands of Size #2-0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080918
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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