Who else makes this device?

Name: Salto Talaris XT
Brand: Salto Talaris XT

Orthopedic › ProstheticProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Salto Talaris XT

2 catalogue numbers from LJU823, listed by Tornier Inc., United States, under Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

2510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HSN
Manufacturer	City	Province	Registered as	Device types
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	10

Record

Regulatory record for Salto Talaris XT
Listed by	Tornier Inc., United States
FDA product code	HSN
Device type	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device class	Class 2
Regulation	21 CFR 888.3110
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2015-10-16
Record revised	2022-06-10 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	expiry date, serial number
Distribution end date	2018-09-11

Catalogue Numbers

Catalogue numbers for Salto Talaris XT
Catalogue number	Size	Status
LJU823	Size 3	Withdrawn
LJU812	Size 2	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Apex 3D Total Ankle Replacement System	Paragon 28	658
Vantage	Exactech, Inc.	362
Cadence™	Ascension Orthopedics, Inc.	248
Cadence Total Ankle System	Smith & Nephew, Inc.	246
Inbone	Wright Medical Technology, Inc.	236
Hintermann Series H2	DT Medtech LLC	225
Infinity	Wright Medical Technology, Inc.	220
Incompass Total Ankle System	Wright Medical Technology, Inc.	213
Invision	Wright Medical Technology, Inc.	186
Kinos Axiom Instrumentation	restor3d, inc.	169
Quantum	In2Bones SAS	157
Hintermann Series H2	Vilex LLC	153

Showing 12 of 53. All products under Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K090076	2009-03-17
K060544	2006-11-13

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2015-08-06	Class II	Nonconforming Material/Component	Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. Th	5	2016-04-08

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.