# K151200: STRATAFIX  Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Aug 13, 2015 after 100 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: 12 generations back to K014153 (2002). 36 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050845: Monocryl Plus Antibacterial Suture, ETHICON, Inc. (2005) Summary page 4.
- K141778: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design, Surgical Specialties Corporation (2014) Summary page 4.
- K123836: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design, Surgical Specialties Corp. Dba Angiotech (2012) Summary page 4.
- K123409: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design, Surgical Specialties Corp. Dba Angiotech (2012) Summary page 4.

## Most influential descendants
- 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 (2019), 7 descendants of its own
- K221744: STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (2022), 2 descendants of its own
- K232246: 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture (2024), 1 descendant of its own
- K192144: STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (2020), 1 descendant of its own
- K252047: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices (2026), 0 descendants of its own

## Recalls of this device
- Sep 20, 2022 · Class II · Z-0150-2023: Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair

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

Source page: https://510kreport.com/device/K151200
Methodology: https://510kreport.com/methodology