FDA.reportPublic FDA data

Persona®

Primary DI
00880304809116
Brand
Persona®
Company
Zimmer, Inc.
Model
42-5399-059-85
Catalog number
42-5399-059-85
Published
2016-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
HTJGAUGE, DEPTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
HTJGauge, DepthOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200151000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200151000Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial DrillZimmer, Inc.2020-03-17HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304809116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304809116008803048091168803048091160880304809116

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guideA non-sterile surgical instrument intended to be attached to a portion of bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure to outline the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024701670Identity® Shoulder System1200046571200046572026-06-09
00889024707382Persona Tensor Sizer Arm – LongSSI008513SSI0085132026-05-29
00889024707399Persona Tensor Sizer Arm – StdSSI008567SSI0085672026-05-29
00889024707405Persona Tensor Sizer BodySSI008566SSI0085662026-05-29
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
10855068008607Implant Selection DeviceCURVAFIX, INC.HTJ2022-12-05
07613327127423INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127447INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127461INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127478INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127485INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127522INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327049305AvonHowmedica Osteonics Corp.HSX2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051186INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24