FDA.reportPublic FDA data

CATALYSTEM

Primary DI
00885556892152
Brand
CATALYSTEM
Company
Smith & Nephew, Inc.
Model
71314205
Catalog number
71314205
Device description
CATALYSTEM BROACH SIZE 5
Published
2024-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEHProsthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123598000SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2013-06-28JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556892152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556892152008855568921528855568921520885556892152

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

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
07630030883576Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883583Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883590Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883606Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883613Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883620Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883637Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883644Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883651Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883668Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883675Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883682Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883699Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883705Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883712Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883729Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883736Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883743Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883750Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883767Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883774Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883781Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883798Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883804Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883811Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883828Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883835Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883842Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883859Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883866Mpact 3D Metal FoamMedacta International SALPH2026-09-04