FDA.reportPublic FDA data

APEX 3D S Total Ankle Replacement System

Primary DI
00889795140456
Brand
APEX 3D S Total Ankle Replacement System
Company
Paragon 28, Inc.
Model
P11-851-P051
Catalog number
P11-851-P051
Device description
Short Stem Tibia, Instrument, Forked Paddle, Arc
Published
2024-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K240259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240259000APEX 3D Total Ankle Replacement SystemParagon 28, Inc.2024-06-24HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795140456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795140456008897951404568897951404560889795140456

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795155856APEX 3D Total Ankle Replacement SystemP11-754-GA01P11-754-GA012026-09-29
00889795155863APEX 3D Total Ankle Replacement SystemP11-854-GA01P11-854-GA012026-09-29
00889795155870APEX 3D Total Ankle Replacement SystemP11-751-TP12P11-751-TP122026-09-29
00889795155887APEX 3D Total Ankle Replacement SystemP11-751-TP34P11-751-TP342026-09-29
00889795155894APEX 3D Total Ankle Replacement SystemP11-751-TP56P11-751-TP562026-09-29
00889795135278Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-1P50-900-AFSL-12026-09-24
00889795135285Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-2P50-900-AFSL-22026-09-24
00889795135292Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-3P50-900-AFSL-32026-09-24
00889795135308Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-4P50-900-AFSL-42026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-5P50-900-AFSL-52026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-6P50-900-AFSL-62026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemP50-900-AFSL-7P50-900-AFSL-72026-09-24
00889795120199Paragon 28 Bone Wedge SystemAOCWO-16-5AOCWO-16-52023-06-26
00889795120632Paragon 28 Bone Wedge SystemAOLEW-22-12AOLEW-22-122023-04-04
00889795118523Paragon 28 Bone Wedge SystemAOCW-TRL-16-4.5AOCW-TRL-16-4.52022-10-14
00889795118530Paragon 28 Bone Wedge SystemAOCW-TRL-16-5.5AOCW-TRL-16-5.52022-10-14
00889795118547Paragon 28 Bone Wedge SystemAOCW-TRL-16-6.5AOCW-TRL-16-6.52022-10-14
00889795118554Paragon 28 Bone Wedge SystemAOCW-TRL-18-4.5AOCW-TRL-18-4.52022-10-14
00889795118561Paragon 28 Bone Wedge SystemAOCW-TRL-18-5.5AOCW-TRL-18-5.52022-10-14
00889795118578Paragon 28 Bone Wedge SystemAOCW-TRL-18-6.5AOCW-TRL-18-6.52022-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795155870APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-09-29
00889795155887APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-09-29
00889795155894APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-09-29
00840097514789Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514796Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514802Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514819Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514826Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514833Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514840Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514857Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514864Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514871Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514888Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514895Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514901Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097514918Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097515694Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097515700Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097515717Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097533742Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097533759Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097533766Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097534046Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00840097536651Kinos Aeros InstrumentationRestor3d, Inc.HSN2026-08-21
00889797114820PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
00889797114837PROPHECY INCOMPASSWRIGHT MEDICAL TECHNOLOGY, INC.HSN2026-06-23
03701337614355QUANTUMIN2BONESHSN2024-12-13
00885556832271Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.HSN2022-12-22
00885556831892Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.HSN2022-12-21