Cleared Traditional

LINK ACETABULAR MESH (K844225) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844225 · Waldemar Link GmbH & Co. KG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
13d
Days
Class 2
Risk

K844225 is an FDA 510(k) clearance for the LINK ACETABULAR MESH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Waldemar Link GmbH & Co. KG (E. Hanover, US). The FDA issued a Cleared decision on November 14, 1984 after a review of 13 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Waldemar Link GmbH & Co. KG devices

Submission Details

510(k) Number K844225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1984
Decision Date November 14, 1984
Days to Decision 13 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K844225.
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
OviTex PRS
K241126 · TELA Bio, Inc. · May 2024
Peri-Guard and Supple Peri-Guard
K223052 · Synovis Life Technologies, Inc. · Apr 2023
OviTex PRS (Long Term Resorbable)
K214070 · Tela Bio · Mar 2023