FDA.reportPublic FDA data

PROFIX

Primary DI
03596010219794
Brand
PROFIX
Company
Smith & Nephew, Inc.
Model
71504340
Catalog number
71504340
Device description
PROFIX 6.5 TIBIAL SCREW 40MM
Published
2015-08-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K933958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933958000RICHARDS TOTAL KNEE SYSTEMSmith & Nephew Richards, Inc.1995-01-09JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010219794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010219794035960102197943596010219794

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556923023NASmith & Nephew, Inc.JWH2026-07-16
08800017262178EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262185EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262192EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262208EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262215EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262222EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262239EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262246EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262253EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262260EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262277EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262284EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262291EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262307EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262314EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262321EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262338EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262345EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262352EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262369EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262376EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262383EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262390EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262406EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262413EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262420EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262437EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262444EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262451EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10