FDA.reportPublic FDA data

Z1™ Hip System

Primary DI
00887868575754
Brand
Z1™ Hip System
Company
Zimmer, Inc.
Model
611203040
Catalog number
611203040
Published
2024-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233476000
K251906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233476000Z1 Hip SystemOrchard Medical Development2024-02-08LZO
K251906000Z1 Hip SystemZimmer, Inc.2025-07-18LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868575754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868575754008878685757548878685757540887868575754

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024713505G7® TM Acetabular System1200013321200013322026-11-03
00889024713512G7® TM Acetabular System7574000427574000422026-11-03
00889024713529G7® TM Acetabular System7574000447574000442026-11-03
00889024713536G7® TM Acetabular System7574000467574000462026-11-03
00889024713543G7® TM Acetabular System7574000487574000482026-11-03
00889024713550G7® TM Acetabular System7574000507574000502026-11-03
00889024713567G7® TM Acetabular System7574000527574000522026-11-03
00889024713574G7® TM Acetabular System7574000547574000542026-11-03
00889024713581G7® TM Acetabular System7574000567574000562026-11-03
00889024713598G7® TM Acetabular System7574000587574000582026-11-03
00889024713604G7® TM Acetabular System7574000607574000602026-11-03
00889024713611G7® TM Acetabular System7574000627574000622026-11-03
00889024713628G7® TM Acetabular System7574000647574000642026-11-03
00889024713635G7® TM Acetabular System7574000667574000662026-11-03
00889024713642G7® TM Acetabular System7574000687574000682026-11-03
00889024713659G7® TM Acetabular System7574000707574000702026-11-03
00889024713666G7® TM Acetabular System7574000727574000722026-11-03
00889024713673G7® TM Acetabular System7574000747574000742026-11-03
00889024713680G7® TM Acetabular System7574000767574000762026-11-03
00889024713697G7® TM Acetabular System7574000787574000782026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713512G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713512G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.KWZ2026-11-03