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)
Top companies in HSN
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corporation | 1 | 28 |
| Wrightmedicaltechnologyinc | 21 | 0 |
| Exactech, Inc. | 4 | 5 |
| Wright Medical Technology Inc | 0 | 9 |
| Paragon 28, Inc. | 8 | 0 |
| Restor3D | 5 | 0 |
| Depuy, Inc. | 4 | 0 |
| In2bones Sas | 4 | 0 |
| Zimmer, Inc. | 1 | 3 |
| Tornier | 2 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2024 | Wright Medical Technology, Inc. stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty Open, Classified |
HSN | K123954 |
| Jan 18, 2024 | Exactech, Inc. Exactech Vantage Ankle System, Catalog Numbers:
a) 350-21-04,
b) 350-22-03 Open, Classified |
HSN | K152217 |
| Jul 7, 2023 | Wright Medical Technology, Inc. Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile. Open, Classified |
HSN | K123954 |
| Oct 27, 2022 | Wright Medical Technology, Inc. Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4 Terminated |
HSN | K051023 |
| Oct 27, 2022 | Wright Medical Technology, Inc. Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3 Terminated |
HSN | K051023 |
| Jun 2, 2022 | Wright 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 |
HSN | K140749 |
| Nov 4, 2021 | Wright Medical Technology Inc INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS Terminated |
HSN | K100886 |
| Nov 4, 2021 | Wright Medical Technology Inc INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS Terminated |
HSN | K100886 |
| Oct 4, 2021 | Exactech, 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 |
HSN | K152217 |
| Aug 10, 2020 | Exactech, Inc. The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm. Open, Classified |
HSN | K152217 |
| Apr 9, 2020 | Wright 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 |
HSN | K051023 |
| Oct 10, 2019 | Zimmer Biomet, Inc. TM Ankle and Ankle Talus L/R, Item Nos. 00450001100
00450001200
00450001300
00450001400
00450001500
00450001600
00450002100
00450002200
00450002300
00450002400
00450002500
00450002600 Terminated |
HSN | K120906 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T Terminated |
HSN | K153452 K182878 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T Terminated |
HSN | K153452 K182878 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T Terminated |
HSN | K153452 K182878 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T Terminated |
HSN | K153452 K182878 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T Terminated |
HSN | K153452 K182878 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T Terminated |
HSN | K153452 K182878 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T Terminated |
HSN | K153452 K182878 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T Terminated |
HSN | K153452 K182878 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Tibial Total Ankle Prosthesis
Tray, Size 2, Product No. LJU222T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T Terminated |
HSN | K060544 K090076 +1 |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T Terminated |
HSN | K060544 K090076 +1 |
| May 16, 2017 | Exactech, 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 |
HSN | K152217 |
| May 16, 2017 | Exactech, 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 |
HSN | K152217 |
| Feb 11, 2017 | Integra LifeSciences Corp. Integra Cadence Total Ankle System Terminated |
HSN | K151459 |
| Nov 8, 2016 | Wright Medical Technology, Inc. INBONE STEM, TIBIAL, TOP, Part Number 200011901 Terminated |
HSN | K051023 |
| Apr 29, 2016 | Integra 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 |
HSN | K151459 |
| Aug 26, 2015 | Tornier, Inc Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile.
Orthopedic Manual Surgical Instrument Terminated |
HSN | K130533 |
| Dec 10, 2013 | Zimmer, 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 |
HSN | K120906 |
| Dec 10, 2013 | Zimmer, 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 |
HSN | K120906 |
| Dec 10, 2013 | Zimmer, 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 |
HSN | K120906 |
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