FDA.reportPublic FDA data

KinematX Total

Primary DI
00842078115671
Brand
KinematX Total
Company
EXTREMITY MEDICAL, LLC
Model
137-00010
Device description
Capitate Reamer
Published
2026-10-29
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
true

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
00842078115671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842078115671008420781156718420781156710842078115671

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, single-useAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
832720358
Device count
1
DM exempt
false
Premarket exempt
true
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
00842078100004HammerFiX132-00050-S2026-10-29
00842078100011HammerFiX132-02800-S2026-10-29
00842078100028HammerFiX132-03400-S2026-10-29
00842078100035HammerFiX132-04000-S2026-10-29
00842078100127HammerFiX132-000112026-10-29
00842078100134HammerFiX132-000142026-10-29
00842078100141HammerFiX132-000162026-10-29
00842078100219HammerFiX132-001112026-10-29
00842078100295IO FiX101-000042026-10-29
00842078100318XMCP101-000062026-10-29
00842078100363IO FiX101-000112026-10-29
00842078100370IO FiX101-000122026-10-29
00842078100387IO FiX101-000132026-10-29
00842078100479IO FiX101-000222026-10-29
00842078100486XMCP101-000232026-10-29
00842078101773XMCP102-000022026-10-29
00842078101889Jones Union102-000332026-10-29
00842078102794IO FiX118-000042026-10-29
00842078102800IO FiX118-000052026-10-29
00842078102817IO FiX118-000062026-10-29

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
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
00810112598629DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31