FDA.reportPublic FDA data

Patient Specific Talus Spacer

Primary DI
00889795137203
Brand
Patient Specific Talus Spacer
Company
Paragon 28, Inc.
Model
AOPSTSXXXXN
Catalog number
AOPSTSXXXXN
Device description
Patient Specific Talus Spacer, Nominal, CoCr
Published
2024-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QNNProsthesis, Total Talus Replacement, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNNProsthesis, Total Talus Replacement, MetalUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H200001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H200001000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795137203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795137203008897951372038897951372030889795137203

GMDN Terms#

Term, Definition table
TermDefinition
Coated ankle talus prosthesisA sterile implantable device designed to replace the proximal talus (talar component) as part of a primary ankle joint replacement or prosthesis revision. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042961576
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795150073APEX 3D Total Ankle Replacement SystemP11-700-TEMPP11-700-TEMP2026-10-12
00889795150080APEX 3D Total Ankle Replacement SystemP11-710-TUF1P11-710-TUF12026-10-12
00889795150097APEX 3D Total Ankle Replacement SystemP11-710-TUF2P11-710-TUF22026-10-12
00889795150103APEX 3D Total Ankle Replacement SystemP11-710-TUF3P11-710-TUF32026-10-12
00889795150110APEX 3D Total Ankle Replacement SystemP11-710-TUF4P11-710-TUF42026-10-12
00889795150127APEX 3D Total Ankle Replacement SystemP11-710-TUF5P11-710-TUF52026-10-12
00889795150134APEX 3D Total Ankle Replacement SystemP11-710-TUF6P11-710-TUF62026-10-12
00889795150141APEX 3D Total Ankle Replacement SystemP11-754-CS12P11-754-CS122026-10-12
00889795150158APEX 3D Total Ankle Replacement SystemP11-754-CT12P11-754-CT122026-10-12
00889795150165APEX 3D Total Ankle Replacement SystemP11-754-CS14P11-754-CS142026-10-12
00889795150172APEX 3D Total Ankle Replacement SystemP11-754-CT14P11-754-CT142026-10-12
00889795150189APEX 3D Total Ankle Replacement SystemP11-754-CS16P11-754-CS162026-10-12
00889795150196APEX 3D Total Ankle Replacement SystemP11-754-CT16P11-754-CT162026-10-12
00889795150202APEX 3D Total Ankle Replacement SystemP11-754-DS12P11-754-DS122026-10-12
00889795150219APEX 3D Total Ankle Replacement SystemP11-754-DT12P11-754-DT122026-10-12
00889795150226APEX 3D Total Ankle Replacement SystemP11-754-DS14P11-754-DS142026-10-12
00889795150233APEX 3D Total Ankle Replacement SystemP11-754-DT14P11-754-DT142026-10-12
00889795150240APEX 3D Total Ankle Replacement SystemP11-754-DS16P11-754-DS162026-10-12
00889795150257APEX 3D Total Ankle Replacement SystemP11-754-DT16P11-754-DT162026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemP11-754-WR01P11-754-WR012026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097509747restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509754restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509761restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509778restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509785restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509846restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509853restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509860restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509877restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509884restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509891restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00840097509907restor3d Total Talus ReplacementRestor3d, Inc.QNN2024-03-15
00889795128119Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795128126Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795128133Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795128768Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795128775Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795128782Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795137197Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07
00889795137210Patient Specific Talus SpacerParagon 28, Inc.QNN2024-03-07