FDA.reportPublic FDA data

P.C.A.

Primary DI
04546540268143
Brand
P.C.A.
Company
Howmedica Osteonics Corp.
Model
6299-3-525
Catalog number
6299-3-525
Device description
0degrees Acetabular Insert
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540268143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540268143045465402681434546540268143

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter28Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26
07613327648485Instrument5533-T-816-R5533-T-816-R2026-02-26
07613327648492Instrument5533-T-814-L5533-T-814-L2026-02-26
07613327651485Instrument5533-T-010-R5533-T-010-R2026-02-26
07613327651492Instrument5533-T-012-R5533-T-012-R2026-02-26
07613327651508Instrument5533-T-016-R5533-T-016-R2026-02-26
07613327651515Instrument5533-T-011-L5533-T-011-L2026-02-26
07613327651522Instrument5533-T-014-L5533-T-014-L2026-02-26
07613327651539Instrument5533-T-009-L5533-T-009-L2026-02-26
07613327651546Instrument5533-T-016-L5533-T-016-L2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862660824NovationExactech, Inc.LWJ2026-03-19
10885862661005N/AExactech, Inc.LWJ2026-03-19
10885862661067N/AExactech, Inc.LWJ2026-03-19
10885862661081N/AExactech, Inc.LWJ2026-03-19
10885862661098N/AExactech, Inc.LWJ2026-03-19
10885862658173EXACTECHExactech, Inc.LWJ2025-11-14
10885862658272EXACTECHExactech, Inc.LWJ2025-11-14
10885862658296EXACTECHExactech, Inc.LWJ2025-11-14
10885862658302EXACTECHExactech, Inc.LWJ2025-11-14
04719886904666U-Motion IIUNITED ORTHOPEDIC CORP.LWJ2025-09-15
04719886904673U-Motion IIUNITED ORTHOPEDIC CORP.LWJ2025-09-15
10885862653246NovationExactech, Inc.LWJ2025-05-15
00887868575563Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575600Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575624Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575655Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575723Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575822Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868575907Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868576027Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868576133Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868576164Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868577116Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868577888Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868578540Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00887868578557Z1™ Hip SystemZimmer, Inc.LWJ2024-09-09
00889024655904Fitmore® Hip StemZimmer GmbHLWJ2023-02-23
07613327460254INSTRUMENTHowmedica Osteonics Corp.LWJ2022-12-20
10885862030948NAExactech, Inc.LWJ2022-10-04
10885862030962NAExactech, Inc.LWJ2022-10-04