# K063680: Sharpoint Pdo (Polydioxanone) Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Specialties Corp
- Decided: May 9, 2007 after 149 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Ethicon's PDS II: named in the summary without a submission number

## Most influential descendants
- K233355: Cypris eXact Suturing System (2024), 0 descendants of its own

## Indications for use
Sharpoint®.PDO sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular, or neurological tissues, microsurgery or ophthalmio surgery.

Source page: https://510kreport.com/device/K063680
Methodology: https://510kreport.com/methodology