ARTHROSURFACE TOEMOTION— 510(k) K132496

Name: FDA 510(k) clearance K132496
Creator: U.S. Food and Drug Administration
Published: 2014-02-26

Substantially Equivalent

Arthrosurface, Inc.

FDA 510(k) clearance K132496 for ARTHROSURFACE TOEMOTION, Substantially Equivalent on 2014-02-26. Applicant: Arthrosurface, Inc.. Device class: Unclassified.

Clearance details

Applicant: Arthrosurface, Inc.
Product code: Code LZJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2013-08-09
Decision date: 2014-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZJ

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K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY2010-12-21
K072251 — MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM2008-05-08
K950864 — GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)1995-07-31
K941650 — TOTAL TOE SYSTEM II1994-12-19
K924724 — KINETIK GREAT TOE SYSTEM1994-01-05

More clearances from Arthrosurface, Inc.

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K203375 — OVOMotion Reverse Shoulder Arthroplasty System2021-06-24
K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System2020-10-15
K190261 — BOSS Toe Fixation System2019-08-14
K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System2018-06-14
K173964 — OVOMotion Shoulder Arthroplasty System2018-04-18

Recalls naming K132496

K-number listed on FDA's recall record

Z-0475-2016 — Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).Class II·Terminated·Arthrosurface, Inc.·20140609

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132496.

Data sourced from openFDA. This site is unofficial and independent of the FDA.