Cleared Special

K241126 - OviTex PRS (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241126 · TELA Bio, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
29d
Days
Class 2
Risk

K241126 is an FDA 510(k) clearance for the OviTex PRS. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by TELA Bio, Inc. (Malvern, US). The FDA issued a Cleared decision on May 22, 2024 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all TELA Bio, Inc. devices

Submission Details

510(k) Number K241126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2024
Decision Date May 22, 2024
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 114d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FTM Mesh, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTM Mesh, Surgical

All 162
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K241126.
Endoform Reconstructive Template - PLGA
K250598 · Aroa Biosurgery , Ltd. · Jun 2025
OviTex PRS (Long-Term Resorbable)
K243595 · TELA Bio, Inc. · Dec 2024
CanGaroo RM Antibacterial Envelope
K233991 · Elutia, Inc. · Jun 2024
Peri-Guard and Supple Peri-Guard
K223052 · Synovis Life Technologies, Inc. · Apr 2023
OviTex PRS (Long Term Resorbable)
K214070 · Tela Bio · Mar 2023
VersaWrap
K213163 · Alafair Biosciences, Inc. · Oct 2021