FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446266273
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
801-05-066
Device description
DJO EMPOWR KNEETM INSERT REINFORCMENT POST EXTRACTOR
Published
2018-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWBEXTRACTOR
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180930000EMPOWR VVC TIBIAL INSERTEncore Medical L.P.2018-07-09JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446266273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446266273001904462662731904462662730190446266273

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
154074504
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446851417DJO SURGICAL800-99-1652024-06-25
00190446735144DJO SURGICAL800-05-0802022-08-17
00190446735151DJO SURGICAL800-05-1322022-08-17
00190446735168DJO SURGICAL800-05-1332022-08-17
00190446735175DJO SURGICAL800-05-1342022-08-17
00190446735182DJO SURGICAL800-05-1352022-08-17
00190446735199DJO SURGICAL800-05-1362022-08-17
00190446735205DJO SURGICAL800-05-1372022-08-17
00190446735212DJO SURGICAL800-05-1382022-08-17
00190446735229DJO SURGICAL800-05-1392022-08-17
00190446735236DJO SURGICAL800-05-1402022-08-17
00190446735243DJO SURGICAL800-05-1412022-08-17
00190446735304DJO SURGICAL800-05-1462022-08-17
00190446735311DJO SURGICAL800-05-1472022-08-17
00190446735328DJO SURGICAL800-05-1482022-08-17
00190446735335DJO SURGICAL800-05-1492022-08-17
00190446735342DJO SURGICAL800-05-1502022-08-17
00190446735359DJO SURGICAL800-05-1512022-08-17
00190446735366DJO SURGICAL800-05-1522022-08-17
00190446735373DJO SURGICAL800-05-1532022-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078115763KinematX TotalEXTREMITY MEDICAL, LLCHWB2026-10-29
04260056886089InterSpace® Knee Mold Femoral Component XSOSARTIS GmbHJWH2026-10-29
04260056886102InterSpace® Knee Mold Femoral Component SOSARTIS GmbHJWH2026-10-29
04260056886126InterSpace® Knee Mold Femoral Component MOSARTIS GmbHJWH2026-10-29
04260056886140InterSpace® Knee Mold Femoral Component LOSARTIS GmbHJWH2026-10-29
04260056886164InterSpace® Knee Mold Femoral Component XLOSARTIS GmbHJWH2026-10-29
04260056886188InterSpace® Knee Mold Tibial Component XSOSARTIS GmbHJWH2026-10-29
04260056886201InterSpace® Knee Mold Tibial Component SOSARTIS GmbHJWH2026-10-29
04260056886263InterSpace® Knee Mold Tibial Component XLOSARTIS GmbHJWH2026-10-29
04260056886225InterSpace® Knee Mold Tibial Component MOSARTIS GmbHJWH2026-10-28
04260056886249InterSpace® Knee Mold Tibial Component LOSARTIS GmbHJWH2026-10-28
00889024702257OsseoFitZimmer, Inc.HWB2026-10-27
05056139247750Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247750Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247804Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247804Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247811Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247811Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247828Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247828Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247835Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247835Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247941Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247941Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247958Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247958Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247965Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247965Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247972Unity Total Knee SystemCORIN LTDJWH2026-10-23
05056139247972Unity Total Knee SystemCORIN LTDOIY2026-10-23