FDA.reportPublic FDA data

Dynasty

Primary DI
M684DMNE28561
Brand
Dynasty
Company
Microport Orthopedics Inc.
Model
DMNE2856
Catalog number
DMNE2856
Device description
E-Class® Dual Mobility Insert 28MM ID 56MM OD
Published
2021-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200011000E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.2021-10-01LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192629235656PrimaryGS10
M684DMNE28561SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629235656001926292356561926292356560192629235656

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Sterilization Methods#

Method table
Method

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192629087255ProfemurPHAC1202PHAC12022026-05-14
00192629087262ProfemurPHAC1204PHAC12042026-05-14
00192629087279ProfemurPHAC1212PHAC12122026-05-14
00192629087286ProfemurPHAC1214PHAC12142026-05-14
00192629087293ProfemurPHAC1222PHAC12222026-05-14
00192629087309ProfemurPHAC1224PHAC12242026-05-14
00192629087316ProfemurPHAC1232PHAC12322026-05-14
00192629087323ProfemurPHAC1234PHAC12342026-05-14
00192629087330ProfemurPHAC1242PHAC12422026-05-14
00192629087347ProfemurPHAC1244PHAC12442026-05-14
00192629087354ProfemurPHAC1252PHAC12522026-05-14
00192629324077ProphecyPNV08601PNV086012021-05-20
00192629324084ProphecyPNV08602PNV086022021-05-20
00192629324091ProphecyPNV08603PNV086032021-05-20
00192629324107ProphecyPNV08604PNV086042021-05-20
00192629324114ProphecyPNV08605PNV086052021-05-20
00192629324121ProphecyPNV08606PNV086062021-05-20
00192629324138ProphecyPNV08607PNV086072021-05-20
00192629324145ProphecyPNV08608PNV086082021-05-20
00192629324152ProphecyPNV08609PNV086092021-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033390276986ArTTLIMACORPORATE SPAOQG2025-09-25
08033390276993ArTTLIMACORPORATE SPAOQG2025-09-25
08033390277006ArTTLIMACORPORATE SPAOQG2025-09-25
08033390286718ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287463ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287470ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287487ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287494ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287500ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287517ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287524ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287531ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287548ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287555ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287562ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287579ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287586ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287593ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287609ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287616ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287623ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287630ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287647ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287654ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287661ArTTLIMACORPORATE SPAOQG2025-09-25
08033390287777ArTTLIMACORPORATE SPAOQG2025-09-25
08033390288279ArTTLIMACORPORATE SPAOQG2025-09-25
08033390289597ArTTLIMACORPORATE SPAOQG2025-09-25
08033390289603ArTTLIMACORPORATE SPAOQG2025-09-25
08033390290210ArTTLIMACORPORATE SPAOQG2025-09-25