FDA.reportPublic FDA data

InSitu Hip System

Primary DI
00816127022593
Brand
InSitu Hip System
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
10-32-0052
Catalog number
10-32-0052
Device description
Acetabular Cup, Size 52, Holed, Anodized
Published
2018-02-16
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161184000iNSitu Total Hip SystemTheken Companies, LLC2016-10-14LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816127022593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816127022593008161270225938161270225930816127022593

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellA sterile, implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter52Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3307337600info@theken.us

Regulatory Flags#

DUNS number
060211165
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
00810030810575InSitu Hip System10-83-04572026-06-01
00810030810582InSitu Hip System10-83-04582026-06-01
00810030810599InSitu Hip System10-83-04592026-06-01
00810030810605InSitu Hip System10-83-04602026-06-01
00810030810612InSitu Hip System10-83-04612026-06-01
00810030810629InSitu Hip System10-83-04622026-06-01
00810030810636InSitu Hip System10-83-04632026-06-01
00810030810643InSitu Hip System10-83-04642026-06-01
00810030810650InSitu Hip System10-83-04652026-06-01
00810030810667InSitu Hip System10-83-04662026-06-01
00810030810674InSitu Hip System10-83-04672026-06-01
00810030810681InSitu Hip System10-83-04682026-06-01
00810030810698InSitu Hip System10-83-04692026-06-01
00810030810704InSitu Hip System10-83-04702026-06-01
00810030811657InSitu Hip System10-95-2081-452026-06-01
00810030811671InSitu Hip System10-95-2081-602026-06-01
00810030811992InSitu Hip System10-85-36482026-06-01
00810030812036InSitu Hip System10-84-20422026-06-01
00810030812043InSitu Hip System10-84-20442026-06-01
00810030812050InSitu Hip System10-84-20462026-06-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07630542788321AMIStem-PMedacta International SALZO2026-06-08
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07630542788345AMIStem-PMedacta International SALZO2026-06-08
07630542788352AMIStem-PMedacta International SALZO2026-06-08
07630542788369AMIStem-PMedacta International SALZO2026-06-08
07630542788376AMIStem-PMedacta International SALZO2026-06-08
04048844017309NAimplantcast GmbHOQI2026-06-02
04048844708443EPORE® XOimplantcast GmbHOQI2026-06-02
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04048844711795EPORE® XOimplantcast GmbHOQI2026-06-02
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04048844712020EPORE® XOimplantcast GmbHOQI2026-06-02
04048844712068EPORE® XOimplantcast GmbHOQI2026-06-02
04048844712099EPORE® XOimplantcast GmbHOQI2026-06-02
04048844712723NAimplantcast GmbHOQI2026-06-02
04048844712747NAimplantcast GmbHOQI2026-06-02
04048844712761NAimplantcast GmbHOQI2026-06-02
04048844712785NAimplantcast GmbHOQI2026-06-02
04048844712808NAimplantcast GmbHOQI2026-06-02
04048844712822NAimplantcast GmbHOQI2026-06-02
04048844712846NAimplantcast GmbHOQI2026-06-02
04048844712860NAimplantcast GmbHOQI2026-06-02
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQI2026-06-01