FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00888912110372
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
213-08-007
Device description
FOUNDATION PS FEMUR, NONPOROUS, TiNbN COATED, SZ 7 LT
Published
2017-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K122239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122239000FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATINGEncore Medical L.P.2013-04-11JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912110372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912110372008889121103728889121103720888912110372

GMDN Terms#

Term, Definition table
TermDefinition
Coated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154074504
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888912024983DJO SURGICAL520-38-0142017-08-07
00888912024990DJO SURGICAL520-38-0182017-08-07
00888912025003DJO SURGICAL520-38-1182017-08-07
00888912025010DJO SURGICAL520-42-0202017-08-07
00888912025027DJO SURGICAL520-42-1162017-08-07
00888912025034DJO SURGICAL520-46-1162017-08-07
00888912025041DJO SURGICAL520-46-1202017-08-07
00888912025058DJO SURGICAL520-50-1182017-08-07
00888912025065DJO SURGICAL520-50-1222017-08-07
00888912025072DJO SURGICAL520-50-1262017-08-07
00888912025089DJO SURGICAL520-54-1182017-08-07
00888912145114DJO SURGICAL520-42-0162017-08-07
00888912145138DJO SURGICAL520-42-1202017-08-07
00888912145145DJO SURGICAL520-46-0162017-08-07
00888912145152DJO SURGICAL520-46-0202017-08-07
00888912145169DJO SURGICAL520-46-0242017-08-07
00888912145190DJO SURGICAL520-46-1242017-08-07
00888912145206DJO SURGICAL520-50-0182017-08-07
00888912145213DJO SURGICAL520-50-0222017-08-07
00888912145220DJO SURGICAL520-50-0262017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020IBI0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20