FDA.reportPublic FDA data

Scorpio

Primary DI
07613153867883
Brand
Scorpio
Company
Howmedica Osteonics Corp.
Model
72-15-0915
Catalog number
72-15-0915
Device description
Posterior Stabilized Tibial 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
Sterile
true
Single use
true

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
K041591000
K243817000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041591000SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTSHowmedica Osteonics Corp.2004-09-23JWH
K243817000Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-02-06JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613153867883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613153867883076131538678837613153867883

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540035523Omnifit2041C-22402041C-22402015-09-24
04546540035714Omnifit2041C-28462041C-28462015-09-24
04546540035790Omnifit2041C-32502041C-32502015-09-24
04546540035806Omnifit2041C-32542041C-32542015-09-24
04546540035813Omnifit2041C-32582041C-32582015-09-24
04546540035820Omnifit2041C-32622041C-32622015-09-24
04546540035837Omnifit2041C-32662041C-32662015-09-24
07613327016772UHRUH1-36-22UH1-36-222015-09-24
07613327016789UHRUH1-38-22UH1-38-222015-09-24
07613327016796UHRUH1-40-22UH1-40-222015-09-24
07613327016802UHRUH1-41-26UH1-41-262015-09-24
07613327016819UHRUH1-41-22UH1-41-222015-09-24
07613327016826UHRUH1-42-26UH1-42-262015-09-24
07613327016833UHRUH1-42-22UH1-42-222015-09-24
07613327016840UHRUH1-43-22UH1-43-222015-09-24
07613327016857UHRUH1-42-28UH1-42-282015-09-24
07613327016864UHRUH1-43-26UH1-43-262015-09-24
07613327016871UHRUH1-44-22UH1-44-222015-09-24
07613327016888UHRUH1-44-26UH1-44-262015-09-24
07613327016895UHRUH1-44-28UH1-44-282015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982533663ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
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00193982533687ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533694ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533700ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533717ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533724ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533731ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533748ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533861ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533878ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533885ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533892ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533908ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533915ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533922ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533939ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533946ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982677428ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982677435ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982677442ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982677459ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
03701089509695AMPLITUDEAMPLITUDE SASJWH2026-07-31
03701089517492TRAXAMPLITUDE SASJWH2026-07-29
03701089517508TRAXAMPLITUDE SASJWH2026-07-29