ClearanceBrief
Panels › Orthopedic › Product code HSN · Class 2

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Regulation 888.3110

2510(k)s in 12 months (69 all time)
0recalls in 12 months (47 all time)
47recalls that name a 510(k)
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Top companies in HSN

DateFirm and productCodeLinked 510(k)
Apr 4, 2024Wright Medical Technology, Inc.
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Open, Classified
HSNK123954
Jan 18, 2024Exactech, Inc.
Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
Open, Classified
HSNK152217
Jul 7, 2023Wright Medical Technology, Inc.
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Open, Classified
HSNK123954
Oct 27, 2022Wright Medical Technology, Inc.
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Terminated
HSNK051023
Oct 27, 2022Wright Medical Technology, Inc.
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
Terminated
HSNK051023
Jun 2, 2022Wright Medical Technology, Inc.
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Open, Classified
HSNK140749
Nov 4, 2021Wright Medical Technology Inc
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Terminated
HSNK100886
Nov 4, 2021Wright Medical Technology Inc
INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Terminated
HSNK100886
Oct 4, 2021Exactech, Inc.
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Lin
Open, Classified
HSNK152217
Aug 10, 2020Exactech, Inc.
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Open, Classified
HSNK152217
Apr 9, 2020Wright Medical Technology Inc
WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion a
Terminated
HSNK051023
Oct 10, 2019Zimmer Biomet, Inc.
TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600
Terminated
HSNK120906
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
Terminated
HSNK153452
K182878
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T
Terminated
HSNK153452
K182878
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
Terminated
HSNK153452
K182878
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
Terminated
HSNK153452
K182878
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T
Terminated
HSNK153452
K182878
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
Terminated
HSNK153452
K182878
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T
Terminated
HSNK153452
K182878
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
Terminated
HSNK153452
K182878
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T
Terminated
HSNK060544
K090076 +1
Mar 8, 2019Integra LifeSciences Corp.
Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T
Terminated
HSNK060544
K090076 +1
May 16, 2017Exactech, Inc.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It
Terminated
HSNK152217
May 16, 2017Exactech, Inc.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis.
Terminated
HSNK152217
Feb 11, 2017Integra LifeSciences Corp.
Integra Cadence Total Ankle System
Terminated
HSNK151459
Nov 8, 2016Wright Medical Technology, Inc.
INBONE STEM, TIBIAL, TOP, Part Number 200011901
Terminated
HSNK051023
Apr 29, 2016Integra LifeSciences Corp.
Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for moveme
Terminated
HSNK151459
Aug 26, 2015Tornier, Inc
Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
Terminated
HSNK130533
Dec 10, 2013Zimmer, Inc.
Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preservi
Terminated
HSNK120906
Dec 10, 2013Zimmer, Inc.
Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preservin
Terminated
HSNK120906
Dec 10, 2013Zimmer, Inc.
Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving
Terminated
HSNK120906

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