📋 FDA Reference
Symbotex Composite Mesh Progrip Self-Gripping Polyester Mesh Parietex Hydrophilic 2d 3d Anatomical Mesh Versatex Monofilament Mesh
Sofradim Production
Summary: The Symbotex Composite Mesh is a self-gripping polyester mesh used in surgical procedures to reinforce soft tissue. It is primarily used by surgeons in hernia repair surgeries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K220586 ↗
Decision Date ?
June 22, 2022
Product Code ?
FTL
Device Class ?
Class 2
Evidence ?
419 studies
The Symbotex Composite Mesh by Sofradim Production was cleared via the FDA 510(k) pathway on June 22, 2022. It is classified as a Class II medical device.
What It Is
The Symbotex Composite Mesh is a surgical mesh designed for soft tissue reinforcement, particularly in hernia repair. It features a self-gripping mechanism that aids in positioning and securing the mesh without the need for additional fixation devices. The mesh is made from polyester and is designed to be hydrophilic, allowing for better integration with the body's tissues.
FDA-Cleared Indications
- Reinforcement of soft tissue where weakness exists, including abdominal wall hernia repair.
- Use in open or laparoscopic surgical procedures when mesh reinforcement is indicated.
- Placement of mesh to support repaired tissue and reduce tension on the repair.
Clinical Applications
- Open repair of abdominal wall hernias, including ventral or incisional hernias.
- Laparoscopic repair of abdominal wall hernias.
- Reinforcement of soft tissue after repair of a weakened or damaged abdominal wall.
- Use of appropriately sized mesh selected for the patient's anatomy and the surgical approach.
Practical Considerations
- The Symbotex product family includes different sizes, shapes and configurations; the surgeon selects the model based on the defect, anatomy and open or laparoscopic approach.
- Self-gripping designs may reduce the need for sutures, tacks or other fixation, but fixation requirements depend on the product model, defect and surgical judgment.
- The mesh must be positioned according to its labeling, including correct orientation of any visceral-facing composite layer and adequate overlap of the defect.
- Contraindications, warnings and precautions include active infection, contamination, inadequate tissue coverage and known sensitivity to device materials; the current product labeling should be reviewed before use.
- MRI safety depends on the exact mesh model and its components. Polyester mesh is generally nonmetallic, but the specific product's current MRI labeling should be confirmed rather than assuming all models have identical conditions.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Symbotex Composite Mesh used for?
It is used for reinforcing soft tissue during hernia repair surgeries.
What specialties typically use this device?
General surgeons, particularly those specializing in hernia repair, commonly use this device.
What are the FDA-cleared indications?
The mesh is indicated for soft tissue reinforcement in hernia repair procedures.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.