FDA.reportPublic FDA data

NEXUS

Primary DI
M684NEXBCH051
Brand
NEXUS
Company
Microport Orthopedics Inc.
Model
NEXBCH05
Catalog number
NEXBCH05
Device description
NEXUS BROACH SIZE 5
Published
2025-07-14
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250444000NEXUS® Hip StemMicroport Orthopedics, Inc.2025-05-15LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192629409965PrimaryGS10
M684NEXBCH051SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629409965001926294099651926294099650192629409965

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)872-0211Stephen.Weaver@ortho.microport.com

Regulatory Flags#

DUNS number
079118736
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
00192629298675ProphecyPNV08001PNV080012020-09-25
00192629298682ProphecyPNV08002PNV080022020-09-25
00192629298699ProphecyPNV08003PNV080032020-09-25
00192629298705ProphecyPNV08004PNV080042020-09-25
00192629298712ProphecyPNV08005PNV080052020-09-25
00192629298729ProphecyPNV08006PNV080062020-09-25
00192629298736ProphecyPNV08007PNV080072020-09-25
00192629298743ProphecyPNV08008PNV080082020-09-25
00192629298750ProphecyPNV08009PNV080092020-09-25
00192629298767ProphecyPNV08010PNV080102020-09-25
00192629298774ProphecyPNV08011PNV080112020-09-25
00192629298781ProphecyPNV08012PNV080122020-09-25
00192629298798ProphecyPNV08013PNV080132020-09-25
00192629298804ProphecyPNV08014PNV080142020-09-25
00192629298811ProphecyPNV08015PNV080152020-09-25
00192629298828ProphecyPNV08016PNV080162020-09-25
00192629298835ProphecyPNV08017PNV080172020-09-25
00192629298842ProphecyPNV08018PNV080182020-09-25
00192629298859ProphecyPNV08019PNV080192020-09-25
00192629298866ProphecyPNV08020PNV080202020-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629032064LineageMicroport Orthopedics Inc.LZO2026-08-18
00192629032033LineageMicroport Orthopedics Inc.LZO2026-08-17
00192629032040LineageMicroport Orthopedics Inc.LZO2026-08-17
00192629032057LineageMicroport Orthopedics Inc.LZO2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
10885862022448NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.LZO2022-09-19
10885862029867NAExactech, Inc.LZO2022-09-19