FDA.reportPublic FDA data

PRIME

Primary DI
M684P3SAQB461
Brand
PRIME
Company
Microport Orthopedics Inc.
Model
P3SAQB46
Catalog number
P3SAQB46
Device description
PRIME AM QUAD SHELL 46 MM GROUP B
Published
2021-09-02
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
K202705000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202705000Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.2021-08-20OQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192629283541PrimaryGS10
M684P3SAQB461SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629283541001926292835411926292835410192629283541

GMDN Terms#

Term, Definition table
TermDefinition
Metallic acetabulum prosthesisA sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of metal [e.g., stainless steel, titanium (Ti)]. Devices designed to assist implantation/fixation (e.g., screws, surgical guides, trial prosthesis, anatomical models) may be included.

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
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812142InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812180InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812197InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812203InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812210InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812227InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812234InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812241InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812258InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812265InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812272InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812289InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812296InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812319InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812326InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01
00810030812333InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCOQG2026-06-01