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Endoform Reconstructive Template

by Aroa Biosurgery Limited (Formerly Mesynthes Limited) 510(k)

Active United States

510(k) K153633

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK153633 Date15 Mar 2016ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

21 recalls · FDA

  • 21 recalls, same reason

    • Terminated Z-0423-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0433-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0420-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0428-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0427-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0431-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0425-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0426-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0421-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0432-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0430-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0417-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0429-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0418-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0415-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0419-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0434-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0424-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0416-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0435-2019 FDA Class II initiated 6 Apr 2018
    • Terminated Z-0422-2019 FDA Class II initiated 6 Apr 2018

    Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.

Specification

510(k)

510(k) Number
FDA Product Code
FTM
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Aroa Biosurgery Limited (Formerly Mesynthes Limited)