FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446648376
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
804-08-006
Device description
ALTIVATE ANATOMIC CS, HUMERAL PLANER, MEDIUM
Published
2020-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PKCProsthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193226000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193226000AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.2020-06-03PKC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446648376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446648376001904466483761904466483760190446648376

GMDN Terms#

Term, Definition table
TermDefinition
Total shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
154074504
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446356820DJO SURGICAL800-02-5062021-02-12
00190446839187DJO SURGICAL804-06-4182024-06-27
00190446839194DJO SURGICAL804-06-4192024-06-27
00190446839200DJO SURGICAL804-06-3182024-06-27
00190446839217DJO SURGICAL804-06-3192024-06-27
00888912024884DJO SURGICAL520-00-0002017-08-07
00190446263906DJO SURGICAL354-10-0402018-07-16
00190446264156DJO SURGICAL354-10-0652018-07-16
00190446264163DJO SURGICAL354-12-0402018-07-16
00190446264170DJO SURGICAL354-12-0652018-07-16
00190446264187DJO SURGICAL354-14-0402018-07-16
00190446264194DJO SURGICAL354-14-0652018-07-16
00190446978213DJO SURGICALS-2019692026-05-01
00190446978268DJO SURGICALS-2019702026-05-01
00190446978275DJO SURGICALS-2019712026-05-01
00190446978282DJO SURGICALS-2019722026-05-01
00888912078634DJO SURGICAL425-97-0052017-08-07
00888912078641DJO SURGICAL425-97-0062017-08-07
00888912078658DJO SURGICAL425-97-0072017-08-07
00888912078665DJO SURGICAL425-97-0082017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556915943AETOS Shoulder SystemSmith & Nephew, Inc.PKC2026-05-18
B1132G1HB300010Shoulder Innovations Humeral Stemless SystemShoulder Innovations, Inc.PKC2026-05-04
B1132G1HB300020Shoulder Innovations Humeral Stemless SystemShoulder Innovations, Inc.PKC2026-05-04
00885556910122AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556910139AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556910146AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556910153AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919354AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919361AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919378AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919392AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919446AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00887868580802IDENTITY HumeralZimmer, Inc.PKC2025-10-10
03701037320426EasyTech AnatomicalFX SOLUTIONSPKC2025-03-03
03701037321010FX V135FX SOLUTIONSPKC2025-02-20
03701037321027FX V135FX SOLUTIONSPKC2025-02-20
03701037321034FX V135FX SOLUTIONSPKC2025-02-20
03701037321041FX V135FX SOLUTIONSPKC2025-02-20
03701037321058FX V135FX SOLUTIONSPKC2025-02-20
03701037321065FX V135FX SOLUTIONSPKC2025-02-20
03701037321072FX V135FX SOLUTIONSPKC2025-02-20
03701037321089FX V135FX SOLUTIONSPKC2025-02-20
03701037321096FX V135FX SOLUTIONSPKC2025-02-20
03701037321102FX V135FX SOLUTIONSPKC2025-02-20
00889024678736OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678743OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678750OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678767OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678774OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18
00889024678781OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18