# K992088: Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
- Decided: Sep 3, 1999 after 74 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900198 (1990). 8 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 23 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.
- K991191: Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture, Genzyme Surgical Product (Genzyme Biosurgery) (1999). Cleared while this submission was under review Summary page 2.
- K972566: Dexon Violet, Davis & Geck, Inc. (1997) Summary page 2.
- K951352: Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid Suture, Davis & Geck, Inc. (1995) Summary page 2.
- K900198: Dexon II Absorbable Surgical Suture, U.S.P., American Cyanamid Co. (1990) 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
- 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-1535-2014: The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
- Jun 6, 2007 · Not classified · Z-1019-2007: Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Jun 6, 2007 · Not classified · Z-1011-2007: Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Jun 6, 2007 · Not classified · Z-1012-2007: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Jun 6, 2007 · Not classified · Z-1013-2007: Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
- Jun 6, 2007 · Not classified · Z-1014-2007: Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

## Indications for use
Bondek® Plus 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/K992088
Methodology: https://510kreport.com/methodology