# K905482: Bondek Polyglycolic Acid Synthetic Absorb. Suture

- Pathway: 510(k) (Traditional)
- Applicant: Pfizer Hospital Products Group, Inc.
- Decided: Mar 14, 1991 after 98 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991191: Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture (1999), 15 descendants of its own
- K992088: Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture (1999), 14 descendants of its own
- 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

## Recalls of this device
- Feb 1, 2010 · Not classified · Z-2286-2010: Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box.

Source page: https://510kreport.com/device/K905482
Methodology: https://510kreport.com/methodology