FDA.reportPublic FDA data

InSitu Hip System

Primary DI
00810030812098
Brand
InSitu Hip System
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
10-84-2054
Device description
Threaded, Impactable Cup Trial, Interference Fit, Size 54
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810030812098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810030812098008100308120988100308120980810030812098

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, prefabricated, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
060211165
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048844017309NAimplantcast GmbHOQI2026-06-02
04048844708443EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711597EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711726EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711740EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711795EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711870EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711917EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711955EPORE® XOimplantcast GmbHOQI2026-06-02
04048844711979EPORE® XOimplantcast GmbHOQI2026-06-02
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, LLCOQI2026-06-01
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQI2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQI2026-06-01