510(k) · Cleared
ClearedPassing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with Ethibond Loop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Aug 3, 2004 as substantially equivalent to K964345 (ETHICON, Inc., 1996) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Aug 3, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010673 (2001). 3 ancestors in all, the oldest K964345 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010673 Arthrex Fiberwire, Model Spu-02NB-3800Arthrex, Inc. · 2001
- 1 generation backK040004 Orthocord SutureDepuy Mitek · 2004 · Recalled
- This deviceK041806 Passing Needle with Ethibond, Panacryl or Orthocord Suture; and…Depuy Mitek, A Johnson & Johnson Company · 2004
- Descendant · cites it directly · 0 of its ownK042233 Passing Needle with Ethibond, Panacryl or Orthocord SutureDepuy Mitek, A Johnson & Johnson Company · 2004
Most influential descendants
Showing 1 of 1 · See all- K042233Passing Needle with Ethibond, Panacryl or Orthocord SutureDepuy Mitek, A Johnson & Johnson Company · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010673 | Arthrex Fiberwire, Model Spu-02NB-3800 | Arthrex, Inc. | 2001 | — |
| −1 | K040004 | Orthocord Suture | Depuy Mitek | 2004 | 1 |
| 0 (this device) | K041806 | Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle… | Depuy Mitek, A Johnson & Johnson Company | 2004 | — |
| +1 | K042233 | Passing Needle with Ethibond, Panacryl or Orthocord Suture | Depuy Mitek, A Johnson & Johnson Company | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 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 GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K964345 | Ethicon Absorbable Poly (L-Lactide/Glycolide) Surgical Suture, UndyedSummary page 2…KO+ [So wiczfl- Substantial Equivalence PANACRYL sutures have been cleared by FDA - K964345; ETHIBOND sutures have been approved by FDA - NDA 17-804 & 17-809;… | 1996 |
| * | K040004 | Orthocord SutureSummary page 2…ETHIBOND sutures have been approved by FDA - NDA 17-804 & 17-809; ORTHOCORD sutures have been cleared by FDA- K040004 Device Classification Sutures are Class I1 devices. Device Description Mitek Passing Needle with ETHIBOND. PAN… | 2004 |
| * | — | ETHIBOND sutures Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042233 | Passing Needle with Ethibond, Panacryl or Orthocord Suture | 2004 | 0 |
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 3 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K042233 (Depuy Mitek, A Johnson & Johnson Company, 2004) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K964345.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
Passing Needle with ETHIBOND, PANACRYL or ORTHCORD suture is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.
Passing Needle with ETHIBOND Loop is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041806 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041806: Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with Ethibond Loop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041806
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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