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
00192629005419ADVANCE®KPONTP26KPONTP262026-09-18
00192629005426ADVANCE®KPONTP29KPONTP292026-09-18
00192629005433ADVANCE®KPONTP32KPONTP322026-09-18
00192629005440ADVANCE®KPONTP35KPONTP352026-09-18
00192629005457ADVANCE®KPONTP38KPONTP382026-09-18
00192629005464ADVANCE®KPONTP41KPONTP412026-09-18
00192629005488ADVANCE®KPON32STKPON32ST2026-09-18
00192629005495ADVANCE®KPON35STKPON35ST2026-09-18
00192629005501ADVANCEKPON38SPKPON38SP2026-09-18
00192629005518ADVANCEKPON41SPKPON41SP2026-09-18
00192629005549ADVANCE®KPRC25HIKPRC25HI2026-09-18
00192629005556ADVANCE®KPRC25LOKPRC25LO2026-09-18
00192629005563ADVANCE®KPRC28HIKPRC28HI2026-09-18
00192629005570ADVANCE®KPRC28LOKPRC28LO2026-09-18
00192629082854EVOLUTIONETPKN1SLETPKN1SL2026-09-18
00192629082861EVOLUTIONETPKN2SLETPKN2SL2026-09-18
00192629082878EVOLUTIONETPKN2PLETPKN2PL2026-09-18
00192629082885EVOLUTIONETPKN3SLETPKN3SL2026-09-18
00192629082892EVOLUTIONETPKN4SLETPKN4SL2026-09-18
00192629082908EVOLUTIONETPKN5SLETPKN5SL2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707160G7® Vivacit-E®Zimmer, Inc.OQG2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCOQG2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.OQG2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCOQG2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.OQG2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCOQG2026-09-30
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000033Triple Taper Stem Standard Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000040Triple Taper Stem High Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000057Triple Taper Stem Standard Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000064Triple Taper Stem High Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000071Triple Taper Stem Standard Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000088Triple Taper Stem High Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000095Triple Taper Stem Standard Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000101Triple Taper Stem High Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000118Triple Taper Stem Standard Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22
09363272000125Triple Taper Stem High Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDOQG2026-09-22