FDA.report

TRULIANT®

Primary DI
10885862608109
Brand
TRULIANT®
Company
Exactech, Inc.
Model
02-022-56-3525
Catalog number
02-022-56-3525
Device description
Porous Tibial Tray without Screw Holes
Published
2024-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions

SubmissionSupplement
K240393000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240393000Exactech® TRULIANT® Knee SystemExactech, Inc.2024-10-03MBH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885862608109PrimaryGS10

GMDN Terms

TermDefinition
Trabeculated knee tibia/insert prosthesisA sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision). It is made of metal (e.g., tantalum alloy) and has a convoluted/perforated surface intended to improve fixation and stability by promoting bone ingrowth; it also includes a polyethylene (PE) insert/platform for femoral articulation. Device implantation is typically intended to be performed without bone cement.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10885862648174Equinoxe313-07-10313-07-102026-03-19
10885862648259Equinoxe313-25-38313-25-382026-03-19
10885862648266Equinoxe313-25-41313-25-412026-03-19
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10885862648280Equinoxe313-25-47313-25-472026-03-19

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