# K990951: Maxon** Sterile, Synthetic, Absorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Apr 1, 1999 after 10 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.
36 later devices descend from it; 4 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Maxon: named in the summary without a submission number

## Most influential descendants
- K082662: V-Loc 180 Absorbable Wound Closure Device (2009), 34 descendants of its own
- K091087: Modification to V-Loc 180 Absorbable Wound Closure Device (2009), 27 descendants of its own
- K113744: Quill Pdo Knotless Tissue-Closure Device (Polydioxanone) (2012), 25 descendants of its own
- K100257: VLOC9ABSORBABLE Wound Closure Device (2010), 24 descendants of its own
- K122898: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design (2012), 19 descendants of its own

## Recalls of this device
- May 3, 2017 · Class II · Z-2542-2017: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

## Indications for use
Maxon and Maxon CV sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue, where growth is expected to occur, and in peripheral vascular tissue.

Source page: https://510kreport.com/device/K990951
Methodology: https://510kreport.com/methodology