FDA.reportPublic FDA data

InSitu Hip System

Primary DI
00810030810674
Brand
InSitu Hip System
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
10-83-0467
Device description
Acetabular Reamer, Low Rider, Crossbar, 67mm
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
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810030810674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810030810674008100308106748100308106740810030810674

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular orthopaedic reamerAn orthopaedic surgical instrument designed to cut and resurface with precision the acetabulum for the acceptance of the acetabular component of a hip joint prosthesis. The device is designed with a hemispherical shell with an abrasive outer surface as the cutting head that is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device.

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
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
00810030812067InSitu Hip System10-84-20482026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078102794IO FiXEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078102800IO FiXEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078102817IO FiXEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078107959XMCPEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078114780Omni MTPEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078115626Jones UnionEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078115633Jones UnionEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078115640Jones UnionEXTREMITY MEDICAL, LLCHTO2026-10-29
00842078115671KinematX TotalEXTREMITY MEDICAL, LLCHTO2026-10-29
04250337120674Inner Drill Reamer 4.0 mm, cannulatedJoimax GmbHHTO2026-10-28
04250337120681Outer Drill, bluntJoimax GmbHHTO2026-10-28
04250337120698Outer Drill, crownJoimax GmbHHTO2026-10-28
04250337120810Inner Drill Reamer 4,0 mm, kanülliert, reusableJoimax GmbHHTO2026-10-28
00889024702264OsseoFitZimmer, Inc.HTO2026-10-27
00889024702271OsseoFitZimmer, Inc.HTO2026-10-27
00889024702318OsseoFitZimmer, Inc.HTO2026-10-27
00889024702325OsseoFitZimmer, Inc.HTO2026-10-27
00889024702332OsseoFitZimmer, Inc.HTO2026-10-27
00889024702349OsseoFitZimmer, Inc.HTO2026-10-27
04250337114086Crown Reamer red, fine, reusableJoimax GmbHHTO2026-10-27
04250337119609Crown Reamer red, fine, reusableJoimax GmbHHTO2026-10-27
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
00810112598537DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598544DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598551DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598568DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598575DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598599DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598605DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598612DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31