# K192580: STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Dec 18, 2019 after 90 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: 14 generations back to K014153 (2002). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182873: STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices, ETHICON, Inc. (2019) Summary page 4.
- K072028: Quill Self-Retaining System (SRS) Comprised of Monoderm, Surgical Specialties Corp (2007) Summary page 4.

## Recalls of this device
- Mar 8, 2024 · Class II · Z-1533-2024: Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility

## Indications for use
STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Source page: https://510kreport.com/device/K192580
Methodology: https://510kreport.com/methodology