FDA.reportPublic FDA data

Salto Talaris Chamfer Cut Total Ankle System

Primary DI
00816847022651
Brand
Salto Talaris Chamfer Cut Total Ankle System
Company
3D SYSTEMS, INC.
Model
Anatomical Model
Device description
A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan.
Published
2024-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OYKAnkle Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYKAnkle Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241148000Salto Talaris Ankle PSI System3D Systems, Inc.2024-08-30OYK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816847022651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847022651008168470226518168470226510816847022651

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy modelA model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
085049749
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816847022859VSP PEEKHost Skull Model2025-11-10
00816847022736Salto Talaris Flat Cut Total Ankle SystemTibia Cutting Guide2025-01-10
00816847022743Salto Talaris Flat Cut Total Ankle SystemTalus Cutting Guide2025-01-10
00816847022750Salto Talaris Flat Cut Total Ankle SystemAnatomical Model2025-01-10
00816847022767Cadence Flat Cut Total Ankle SystemTalus Cutting Guide2025-01-10
00816847022774Cadence Flat Cut Total Ankle SystemTibia Cutting Guide2025-01-10
00816847022781Cadence Flat Cut Total Ankle SystemAnatomical model2025-01-10
00816847022637Cadence Chamfer Cut Total Ankle SystemAnatomical model2024-09-12
00816847022675VSP PEEKCranial Implant2024-09-12
00816847022699Salto Talaris Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022705Salto Talaris Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
00816847022712Cadence Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022729Cadence Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
00816847022798Vantage 3D PSITibia Cutting Guide2024-08-05
00816847022804Vantage 3D PSITalus Cutting Guide2024-08-05
00816847022811Vantage 3D PSIAnatomical Model2024-08-05
00816847022828Vantage 3D+ PSITibia Cutting Guide2024-08-05
00816847022835Vantage 3D+ PSITalus Cutting Guide2024-08-05
00816847022842Vantage 3D+ PSIAnatomical Model2024-08-05
00816847022576Vantage PSITalus Cutting Guide351-80-002020-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731147431OPTIXVILEX LLCOYK2026-03-03
00816847022736Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022743Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022750Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022767Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022774Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022781Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.OYK2025-01-10
00816847022637Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022699Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022705Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022712Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022729Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022798Vantage 3D PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022804Vantage 3D PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022811Vantage 3D PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022828Vantage 3D+ PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022835Vantage 3D+ PSI3D SYSTEMS, INC.OYK2024-08-05
00816847022842Vantage 3D+ PSI3D SYSTEMS, INC.OYK2024-08-05
00840097509914restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-09-27
00840097509921restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-09-27
00840097509938restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-09-27
00840097509945restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-09-27
00840097508924restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-05-01
00840097508931restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-05-01
00840097508948restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-05-01
00840097508955restor3d Kinos Axiom PSR Restor3d, Inc.OYK2023-05-01
00816847022576Vantage PSI3D SYSTEMS, INC.OYK2020-11-13
00816847022606Vantage PSI3D SYSTEMS, INC.OYK2020-11-13
00816847022583Vantage PSI3D SYSTEMS, INC.OYK2020-11-13
00816847022590Vantage PSI3D SYSTEMS, INC.OYK2020-11-13