FDA.report

implaFit®

Primary DI
04048844693367
Brand
implaFit®
Company
implantcast GmbH
Model
80090001
Device description
short stem with collar cementless standard
Published
2026-03-26
Public version status
Update
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
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or 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

CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or 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

SubmissionSupplement
K252401000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K252401000implaFit® short stemsImplantcast GmbH2026-03-12LZO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048844693367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048844693367040488446933674048844693367

GMDN Terms

TermDefinition
Press-fit femoral stem prosthesisA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

Device Sizes

TypeValueUnit
Device Size Text, specify0

Regulatory Flags

DUNS number
324369826
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04048844693411implaFit®800900062026-03-26
04048844693442implaFit®800900092026-03-26
04048844693510implaFit®800910032026-03-26
04048844693565implaFit®800910082026-03-26
04048844693596implaFit®800910112026-03-26
04048844693350implaFit®800900002026-03-17
04048844693374implaFit®800900022026-03-17
04048844693381implaFit®800900032026-03-17
04048844693398implaFit®800900042026-03-17
04048844693404implaFit®800900052026-03-17
04048844693428implaFit®800900072026-03-17
04048844693435implaFit®800900082026-03-17
04048844693459implaFit®800900102026-03-17
04048844693466implaFit®800900112026-03-17
04048844693473implaFit®800900122026-03-17
04048844693497implaFit®800910012026-03-17
04048844693503implaFit®800910022026-03-17
04048844693527implaFit®800910042026-03-17
04048844693534implaFit®800910052026-03-17
04048844693541implaFit®800910062026-03-17

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