FDA.reportPublic FDA data

implaFit® hip stem with collar cemented lateralized

Primary DI
04048844477400
Brand
implaFit® hip stem with collar cemented lateralized
Company
implantcast GmbH
Model
80081002
Published
2022-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210678000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210678000implaFit® hip stemsImplantcast GmbH2022-08-17LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048844477400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844477400040488444774004048844477400

GMDN Terms#

Term, Definition table
TermDefinition
Coated femoral stem prosthesis, one-pieceA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
324369826
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048844017309NA258628052026-06-02
04048844708443EPORE® XO022080502026-06-02
04048844711597EPORE® XO022080622026-06-02
04048844711726EPORE® XO02208058002026-06-02
04048844711740EPORE® XO02208062002026-06-02
04048844711795EPORE® XO02208072002026-06-02
04048844711870EPORE® XO022090562026-06-02
04048844711917EPORE® XO02209048002026-06-02
04048844711955EPORE® XO02209056002026-06-02
04048844711979EPORE® XO022090602026-06-02
04048844712020EPORE® XO02209064002026-06-02
04048844712068EPORE® XO02209068002026-06-02
04048844712099EPORE® XO022090722026-06-02
04048844712723NA025632462026-06-02
04048844712747NA025636542026-06-02
04048844712761NA025636622026-06-02
04048844712785NA025640542026-06-02
04048844712808NA025640622026-06-02
04048844712822NA025828422026-06-02
04048844712846NA025836502026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448883MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04026575448890MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
00810068850079Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850086Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850093Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850109Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850123Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850130Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850147Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850154Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850185Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850192Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850208Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850215Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850222Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850239Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26