Absorbable surgical sutures
FDA guidance covers several absorbable surgical suture types and specifies performance labeling for tensile-strength loss and absorption time.
EVIDENCE
The evidence must fit the device.
Clinical use, a regulatory clearance, a lab study and a promising scientific demonstration mean different things. This guide keeps those distinctions visible.
CLINICAL & REGULATORY CONTEXT
Four useful examples.
Resorbable fixation & mesh
FDA documentation demonstrates selected craniofacial fixation and surgical mesh products, with device-specific indications and limitations.
ABSORB GT1 vascular scaffold
FDA records list approval in July 2016 and withdrawal in May 2023. It is a reminder that clinical outcomes—not material promise—must govern interpretation.
Transient electronic systems
Current research reports biodegradable components and experimental stimulation systems, but does not establish broad human clinical availability.
Primary references.
- FDA — Surgical Sutures: Class II Special Controls
- FDA — Synthes Rapid Resorbable Fixation System (K062789)
- FDA — Phasix Mesh 510(k) Summary, K161424
- FDA — ABSORB GT1 Bioresorbable Vascular Scaffold, P150023
- FDA — Quality Management System Regulation (QMSR)
- ISO 10993-1:2025 — Biological Evaluation of Medical Devices
These references support specific product histories or research findings. They do not establish affiliation with Resorbables.com or endorsement of this domain.
DIRECT ANSWERS
Questions worth asking.
Does “bioresorbable” mean FDA-approved?
No. Regulatory status belongs to a specific product and intended use, not a generic materials category.