# K024117: Insorb Absorbable Staples, Model SP-B20

- Pathway: 510(k) (Traditional)
- Applicant: Incisive Surgical, Inc.
- Decided: Apr 22, 2003 after 130 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- 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 K915489 (1992). 5 ancestors in all.
68 later devices descend from it; 3 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915489: Auto Suture Absorable Subcuticular Closure Staple, United States Surgical, A Division of Tyco Healthc (1992) Summary page 1.
- K915693: Proximate Absorbable Staples, ETHICON, Inc. (1992) Summary page 1.
- K022269: Coated Vicryl* (Polyglactin 910) Suture, ETHICON, Inc. (2002) Summary page 1.
- K974299: Panacryl, ETHICON, Inc. (1998) Summary page 1.
- K962480: Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture, Undyed, ETHICON, Inc. (1996) Summary page 2.

## Most influential descendants
- K051609: Quill Synthetic Absorbable Barbed Suture (2005), 64 descendants of its own
- K071989: Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material (2007), 31 descendants of its own
- K080680: Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone (2008), 30 descendants of its own
- K080985: Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) (2008), 29 descendants of its own
- K072028: Quill Self-Retaining System (SRS) Comprised of Monoderm (2007), 26 descendants of its own

## Recalls of this device
- Mar 19, 2015 · Class II · Z-1545-2015: A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05.

## Indications for use
Synthetic absorbable INSORB staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.

Source page: https://510kreport.com/device/K024117
Methodology: https://510kreport.com/methodology