FDA.reportPublic FDA data

Salto Talaris Chamfer Cut Total Ankle System

Primary DI
00816847022705
Brand
Salto Talaris Chamfer Cut Total Ankle System
Company
3D SYSTEMS, INC.
Model
Tibia Cutting Guide
Device description
A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes
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
00816847022705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847022705008168470227058168470227050816847022705

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, single-useA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a single-use device.

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
00816847022651Salto Talaris Chamfer Cut Total Ankle SystemAnatomical Model2024-09-12
00816847022675VSP PEEKCranial Implant2024-09-12
00816847022699Salto Talaris Chamfer Cut Total Ankle SystemTalus 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
00816847022651Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.OYK2024-09-12
00816847022699Salto 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