FDA.reportPublic FDA data

R3

Primary DI
00885556021668
Brand
R3
Company
Smith & Nephew, Inc.
Model
71339162
Catalog number
71339162
Device description
R3 CONSTRAINED ACETABULAR LINER 62MM
Published
2015-08-30
Public version status
Update
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
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083566000
K111635000
K122139000
K211176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083566000R3 CONSTRAINED LINER, CONSTRAINED LINERSmith & Nephew, Inc.2009-03-03KWZ
K111635000SMITH & NEPHEW RJ CONSTRAINED LINERSSmith & Nephew, Inc.2011-09-09KWZ
K122139000SMITH & NEPHEW R3 CONSTRAINED LINERSSmith & Nephew, Inc.2012-10-16KWZ
K211176000Smith & Nephew Hip SystemsSmith & Nephew, Inc.2022-07-01LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556021668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556021668008855560216688855560216680885556021668

GMDN Terms#

Term, Definition table
TermDefinition
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 may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.

Contacts#

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

Regulatory Flags#

DUNS number
045483575
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
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
00885556833933Salto Talaris Total Ankle ProsthesisMJU952TMJU952T2022-12-22
00885556833940Salto Talaris Total Ankle ProsthesisMJU953TMJU953T2022-12-22
00885556833957Salto Talaris Total Ankle ProsthesisMJV219TMJV219T2022-12-22
00885556833964Salto Talaris Total Ankle ProsthesisMJV220TMJV220T2022-12-22
00885556833971Salto Talaris Total Ankle ProsthesisMJV221TMJV221T2022-12-22
00885556833988Salto Talaris Total Ankle ProsthesisMJV229TMJV229T2022-12-22
00885556834237Silicone Toe SystemCGT-205TCGT-205T2022-12-22
00885556834251Silicone Toe SystemCGT-305TCGT-305T2022-12-22
00885556834299Silicone Toe SystemCGT-505TCGT-505T2022-12-22
00885556835029Ti6 Internal Fixation SystemDS1007DS10072022-12-22
00885556835203Surgical InstrumentsFS-1006FS-10062022-12-22
00885556836187Ti6 Internal Fixation SystemTH3018TH30182022-12-22
00885556837856Total Foot System 2220425022042502022-12-22
00885556838785Total Foot System 2282302728230272022-12-21
00885556841631XT Revision Ankle Replacement SystemMJU984TMJU984T2022-12-21
00885556841778XT Revision Ankle Replacement SystemMJV222TMJV222T2022-12-21
00885556841785XT Revision Ankle Replacement SystemMJV223TMJV223T2022-12-21
00885556854921Freedom Wrist Arthroplasty System3480473480472022-12-22
00885556856680Surgical InstrumentsEXT-200-00EXT-200-002022-12-22
00885556860168Titan Modular Shoulder System 2.5DRL-0923-047-001DRL-0923-047-0012022-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707467Z1® Hip SystemZimmer, Inc.KWZ2026-07-29
09348215154332World Cup G-Zero Liner - Size 32ASIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-06-26
09348215154356World Cup G-Zero Liner - Size 36BSIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-06-26
09348215154363World Cup G-Zero Liner - Size 36CSIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-06-26
09348215154370World Cup G-Zero Liner - Size 36DSIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-06-26
10885862013767NAExactech, Inc.KWZ2022-07-28
10885862142627NAExactech, Inc.KWZ2022-07-28
00885556321942REDAPTSmith & Nephew, Inc.KWZ2016-02-24
00885556321393REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321492REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321591REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321690REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321744REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00885556321843REDAPTSmith & Nephew, Inc.KWZ2015-12-11
00880304474185Arcos® Modular Revision Hip SystemBiomet Orthopedics, LLCKWZ2015-10-24
00880304474246Arcos® Modular Revision Hip SystemBiomet Orthopedics, LLCKWZ2015-10-24
00880304539259Arcos® Modular Revision Hip SystemBiomet Orthopedics, LLCKWZ2015-10-24
10603295218289S-ROMDEPUY (IRELAND)KWZ2015-09-24
10603295218470S-ROMDEPUY (IRELAND)KWZ2015-09-24
10603295218487S-ROMDEPUY (IRELAND)KWZ2015-09-24
10603295218951S-ROMDEPUY (IRELAND)KWZ2015-09-24
07613153071273RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071297RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071310RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071341RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.KWZ2015-09-24