# K030212: Monodek Synthetic Absorbable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Biosurgery
- Decided: Mar 27, 2003 after 65 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K013274 (2001). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013274: Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile, Cp Medical (2001)
- (no number) Ethicon PDS II Absorbable Surgical Suture: named in the summary without a submission number

## Most influential descendants
- K181774: Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture (2018), 10 descendants of its own
- K230311: HyperSuture (2023), 4 descendants of its own
- K191268: Force Fiber Suture (2019), 2 descendants of its own
- K242201: HyperSuture White/Green Extension Line (2025), 1 descendant of its own
- K210675: EasyWhip (2021), 1 descendant of its own

## Recalls of this device
- Mar 11, 2014 · Class II · Z-1534-2014: The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
- Mar 11, 2014 · Class II · Z-1509-2014: Product does not meet minimum knot tensile strength requirements.
- Jun 6, 2007 · Not classified · Z-1016-2007: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

## Indications for use
MonodekTM Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and opthalmic surgery. Monodek suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.

Source page: https://510kreport.com/device/K030212
Methodology: https://510kreport.com/methodology