Lesser Metatarsal Phalangeal Joint Implant

• • Terminated Z-0455-2010 FDA Unclassified (pre-2012) ·initiated 6 Apr 2009

  Tornier, Inc. has received a report of a mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the package was Tornier FGT-50 implant (Primus Flexible Great Toe Implant With Grommetts).

510(k) Number

K023531 ↗

FDA Product Code

KWH

Device Class

Class II

Regulation

21 CFR Part 888.3720

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Futura Biomedical Flexible Great Toe Implant

  Class II

  FDA 510(k) K981194 Active Cleared 30 Jun 1998

• Osteocure Resorbable Bead Kit

  Class II

  FDA 510(k) K051406 Active Cleared 1 Aug 2005

• Modification to Classic Great Toe Implant

  Class II

  FDA 510(k) K023562 Active Cleared 13 Nov 2002

• Classic Great Toe Implant

  Class II

  FDA 510(k) K023086 Active Cleared 4 Oct 2002

• Subtalar Peg Implant

  Class II

  FDA 510(k) K033046 Active Cleared 23 Dec 2003

• NexFix Compression Staple

  Class II

  FDA 510(k) K070688 Active Cleared 18 May 2007

See all devices from Nexa Orthopedics, Inc. →