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510(k) K132496

ARTHROSURFACE TOEMOTION by Arthrosurface, Inc. — Product Code LZJ

K132496 is an FDA 510(k) premarket notification submitted by Arthrosurface, Inc. for the device "ARTHROSURFACE TOEMOTION". The FDA issued a decision of Substantially Equivalent on February 26, 2014. The device falls under product code LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained), a Class U device. Arthrosurface, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2014
Date Received
August 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Arthrosurface, Inc.

  • K203375 — OVOMotion Reverse Shoulder Arthroplasty System (June 24, 2021)
  • K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System (October 15, 2020)
  • K190261 — BOSS Toe Fixation System (August 14, 2019)
  • K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System (June 14, 2018)
  • K173964 — OVOMotion Shoulder Arthroplasty System (April 18, 2018)
  • K172383 — Arthrosurface Bone Screws (December 22, 2017)
  • K170440 — KISSloc Suture System (May 3, 2017)
  • K170350 — ToeMATE® Hammertoe Correction System (March 3, 2017)
  • K162391 — AlignMATE™ Lapidus Arthrodesis System (February 21, 2017)
  • K161539 — Arthrosurface Bone Screws (June 30, 2016)

Other clearances for product code LZJ

  • K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY (December 21, 2010)
  • K072251 — MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM (May 8, 2008)
  • K950864 — GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) (July 31, 1995)
  • K941650 — TOTAL TOE SYSTEM II (December 19, 1994)
  • K924724 — KINETIK GREAT TOE SYSTEM (January 5, 1994)
  • K922211 — OSTEOMED GREAT TOE SYSTEM (November 9, 1993)
  • K920446 — TOTAL TOE SYSTEM (March 22, 1993)
  • K920667 — GREAT TOE IMPLANT (June 19, 1992)
  • K911552 — ANATOMIC TOE SYSTEM (June 28, 1991)
  • K884561 — KOENIG TOTAL TOE IMPLANT (January 24, 1989)

FDA data resources