FDA.reportPublic FDA data

BioMotion Cannulated 1st MPJ Hemi System

Primary DI
00885556821718
Brand
BioMotion Cannulated 1st MPJ Hemi System
Company
Smith & Nephew, Inc.
Model
HM2100
Catalog number
HM2100
Device description
CANNULATED HEMI IMPLANT LARGE (21MM)
Published
2022-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWDPROSTHESIS, TOE, HEMI-, PHALANGEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWDProsthesis, Toe, Hemi-, PhalangealOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083469000METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000Metasurg2009-02-13KWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556821718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556821718008855568217188855568217180885556821718

GMDN Terms#

Term, Definition table
TermDefinition
Wrist ulna-head prosthesisA sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a one-piece or modular device made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and/or polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G712PN00720120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00734100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00734120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00763100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00763120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN007641HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00765100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00765120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00774100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00774120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00777100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00777120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN007840HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
00810005668095TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668101TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668118TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668187TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810135963565TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810135963572TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00850044114962Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635037Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635198Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635204Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635211Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635228Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635235Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635242Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635259Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635266Accu-JointAccufix Surgical, Inc.KWD2024-11-11