# K991191: Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
- Decided: Jun 22, 1999 after 75 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
Longest line of descent: 1 generation back to K905482 (1991). 4 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905482: Bondek Polyglycolic Acid Synthetic Absorb. Suture, Pfizer Hospital Products Group, Inc. (1991) Summary page 2.
- K946271: Vicryo* (Polyglactin 910) Braided Coated and Uncoated Synthetic Absorbable Suture, Dyed & Undyed, Braided and Monofilamt, ETHICON, Inc. (1995) Summary page 2.
- K915835: Coated Vicryl* II, ETHICON, Inc. (1992) Summary page 2.
- K965162: Lukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture,Coated, Braided-U.S.P., Lukens Medical Corp. (1997) Summary page 2.

## Cited in the summary but kept off the family tree
- K930378: 25 CM2, 75 CM2, 150 CM2 Flask, Catalog #03-441, Proteins Intl., Inc. (1993). Our OCR of the scanned summary read K930378, FDA’s number for 25 CM2, 75 CM2, 150 CM2 Flask, Catalog #03-441 (Proteins Intl., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Bondek Synthetic Absorbable Surgical Suture”. Kept off the family tree. Summary page 2.

## Most influential descendants
- 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
- K242201: HyperSuture White/Green Extension Line (2025), 1 descendant of its own

## Recalls of this device
- Feb 1, 2010 · Not classified · Z-2287-2010: Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box.

## Indications for use
Bondek® Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Source page: https://510kreport.com/device/K991191
Methodology: https://510kreport.com/methodology