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Found 7 results
510(k) Data Aggregation
K Number
K243173Device Name
Salto Talaris Ankle PSI System
Manufacturer
3D Systems, Inc.
Date Cleared
2024-10-25
(25 days)
Product Code
OYK
Regulation Number
888.3110Why did this record match?
Product Code :
OYK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Salto Talaris Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Salto Talaris Ankle PSI System is intended for use with Smith + Nephew's Salto Talaris Total Ankle System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
Device Description
3D Systems' Salto Talaris Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Salto Talaris Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Salto Talaris Total Ankle System instruments, facilitate the positioning of Salto Talaris Total Ankle Prostheses.
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K Number
K243174Device Name
Cadence Ankle PSI System
Manufacturer
3D Systems, Inc.
Date Cleared
2024-10-25
(25 days)
Product Code
OYK
Regulation Number
888.3110Why did this record match?
Product Code :
OYK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
Device Description
3D Systems' Cadence Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Cadence Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Cadence Total Ankle System instruments, facilitate the positioning of Cadence Total Ankle Prostheses.
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K Number
K241148Device Name
Salto Talaris Ankle PSI System
Manufacturer
3D Systems, Inc.
Date Cleared
2024-08-30
(127 days)
Product Code
OYK
Regulation Number
888.3110Why did this record match?
Product Code :
OYK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Salto Talaris PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Salto Talaris PSI System is intended for use with Smith + Nephew's Salto Talaris Total Ankle System and its cleared indications for use.
Device Description
3D Systems' Salto Talaris Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Salto Talaris Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Salto Talaris Total Ankle System instruments, facilitate the positioning of Salto Talaris Total Ankle Prostheses.
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K Number
K241326Device Name
Cadence Ankle PSI System
Manufacturer
3D Systems, Inc.
Date Cleared
2024-08-30
(112 days)
Product Code
OYK
Regulation Number
888.3110Why did this record match?
Product Code :
OYK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cadence Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence Total Ankle System and its cleared indications for use.
Device Description
3D Systems' Cadence Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Cadence Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Cadence Total Ankle System instruments, facilitate the positioning of Cadence Total Ankle Prostheses.
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K Number
K231585Device Name
Vantage PSI System
Manufacturer
3D Systems, Inc.
Date Cleared
2023-06-30
(30 days)
Product Code
OYK
Regulation Number
888.3110Why did this record match?
Product Code :
OYK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vantage PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intra-operatively, and in guiding bone cutting. The Vantage PSI System is intended for use with Exactech's Vantage Total Ankle System and its cleared indications for use.
Device Description
3D System's Vantage PSI System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Exacted Vantage Total Ankle reusable instruments, facilitate the positioning of Vantage Total Ankle Implants. 3D System s Vantage PSI System produces a variety of patient specific outputs including surgical quides, anatomic models, and case reports.
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K Number
K223326Device Name
Axiom PSR System
Manufacturer
Restor3d
Date Cleared
2023-03-30
(150 days)
Product Code
OYK
Regulation Number
888.3110Why did this record match?
Product Code :
OYK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Axiom PSR System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Axiom PSR System is intended for use with the Kinos Axiom Total Ankle System and its cleared indications for use.
Device Description
restor3d's Axiom PSR System is an ankle surgical guide system, designed for an individual patient from the patient's CT imaging scans. The subject Axiom PSR System is intended to aid in the placement of Kinos Axiom Total Ankle System (K192778) implant components when used in conjunction with the Kinos Axiom standard, reusable instruments. The Axiom PSR System includes preoperative plans developed with and approved by the operative surgeon, tibia and talus resection guides, manufactured from implant grade titanium, bone models manufactured from biocompatible polymer for use with the Kinos Axiom Total Ankle System.
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K Number
K193432Device Name
Vantage PSI System
Manufacturer
3D Systems
Date Cleared
2020-11-09
(335 days)
Product Code
OYK
Regulation Number
888.3110Why did this record match?
Product Code :
OYK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vantage PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Vantage PSI System is intended for use with Exactech's Vantage Total Ankle System and its cleared indications for use.
Device Description
3D System's Vantage PSI System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Exactech Vantage Total Ankle reusable instruments, facilitate the positioning of Vantage Total Ankle Implants. 3D System's Vantage PSI System produces a variety of patient specific outputs including surgical guides, anatomic models, and case reports for use with Exactech's Vantage Total Ankle System (K152217 and K183343).
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