510(k) · Cleared
Recalled · Class II · 2013Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with Needle and Without Needle, Digitex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on May 23, 2012 as substantially equivalent to K093112 (Coloplast Manufacturing Us, LLC, 2010) and 4 other predicates after a 113-day review. Its family tree reaches back 3 generations to 1990. It has been recalled once.
- Decided
- May 23, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- NEW
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 3 generations to K900198 (1990). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK900198 Dexon II Absorbable Surgical Suture, U.S.P.American Cyanamid Co. · 1990
- 2 generations backK972566 Dexon VioletDavis & Geck, Inc. · 1997
- 1 generation backK992088 Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1999 · Recalled
- This deviceK120284 Digitex Suture Delivery System, Digitexpolypropylene Suture…Coloplast A/S · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900198 | Dexon II Absorbable Surgical Suture, U.S.P. | American Cyanamid Co. | 1990 | — |
| −2 | K972566 | Dexon Violet | Davis & Geck, Inc. | 1997 | — |
| −1 | K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture | Genzyme Surgical Product (Genzyme Biosurgery) | 1999 | 6 |
| 0 (this device) | K120284 | Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0… | Coloplast A/S | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 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 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? (5)
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 |
|---|---|---|---|
| * | K093112 | Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (Size O), Model…Summary page 1…gitex Delivery Device, Digitex Suture Cartridge Predicate Devices Digitex System: Digitex Suture Delivery System: K0931 12 Proposed Digitex Suture Cartridge predicates: Deknatel Deklene 11suture, K930738; ___… | 2010 |
| * | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcSummary page 1…Digitex System: Digitex Suture Delivery System: K0931 12 Proposed Digitex Suture Cartridge predicates: Deknatel Deklene 11suture, K930738; ___________________Monodelk PDO suture, K030212; Bondek PGA suture, K<991191 & K992088 Device Description The… | 1994 |
| * | K030212 | Monodek Synthetic Absorbable Surgical SutureSummary page 1…Proposed Digitex Suture Cartridge predicates: Deknatel Deklene 11suture, K930738; ___________________Monodelk PDO suture, K030212; Bondek PGA suture, K<991191 & K992088 Device Description The Digitex SIDS is composed of delivery device and suture cartridge an… | 2003 |
| * | K991191 | Bondek Polyglycolic Acid Synthetic Absorbable Surgical SutureSummary page 1…scientific technology as the predicates Digitex Suture Delivery System: K0931 12, Delknatel Delene 11suture, K930738; Monodek PDO suture, K030212; and Bondek PGA suture, K991191 & K992088. Summary Of The Nonclinical Tests Submitted The modifications to the Digitex Suture Cartridges, specifically, adding su… | 1999 |
| * | K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureSummary page 1…igitex Suture Cartridge predicates: Deknatel Deklene 11suture, K930738; ___________________Monodelk PDO suture, K030212; Bondek PGA suture, K<991191 & K992088 Device Description The Digitex SIDS is composed of delivery device and suture cartridge and is designed for use byrthe physician… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2013 | Class II | Z-1486-2013 | Incorrect or no expiration date | Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 8 of the 13 ancestors have a recall of any class.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and knot-tying by holding the suture.
The Digitex Suture Cartridge holds sterile suture indicated for soft tissue approximation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120284 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120284: Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with Needle and Without Needle, Digitex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120284
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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