FDA.reportPublic FDA data

APEX 3D Total Ankle Replacement System

Primary DI
00889795128850
Brand
APEX 3D Total Ankle Replacement System
Company
Paragon 28, Inc.
Model
P10-200-TLL5-S
Catalog number
P10-200-TLL5-S
Device description
Total Ankle Implant, Talus, Chamfer, Left, Size 5, CoCr DB
Published
2025-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250641000APEX 3D Total Ankle Replacement SystemParagon 28, Inc.2025-05-01HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795128850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795128850008897951288508897951288500889795128850

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795103482Paratrooper™ Plantar Plate Repair SystemP13-000-WEIL-SKP13-000-WEIL-SK2022-10-14
00889795154804Grappler® Suture Anchor SystemP63-001-3510-SKP63-001-3510-SK2026-11-04
00889795154811Grappler® Suture Anchor SystemP63-001-4515-SKP63-001-4515-SK2026-11-04
00889795154828Grappler® Suture Anchor SystemP63-001-5515-SKP63-001-5515-SK2026-11-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795150080APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150097APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150103APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150110APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150127APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795150134APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151001APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151018APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151025APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151032APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151049APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151056APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151063APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151070APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151087APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151094APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151100APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151117APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151124APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151131APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151148APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151155APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151162APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151179APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151186APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151193APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151209APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151216APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151223APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12
00889795151230APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-10-12