FDA.reportPublic FDA data

APEX PS Knee

Primary DI
00841690113034
Brand
APEX PS Knee
Company
Omnilife Science, Inc
Model
KP-20114
Catalog number
KP-20114
Device description
PS Insert, Size 1 x 14mm
Published
2015-11-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841690113034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841690113034008416901130348416901130340841690113034

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-6664CS@omnils.com

Regulatory Flags#

DUNS number
061339651
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841690129943APEX Knee SystemKP-22613KP-226132021-07-08
00841690100805APEX CR KneeKC-1101LKC-1101L2015-11-27
00841690100812APEX CR KneeKC-1101RKC-1101R2015-11-27
00841690100829APEX CR KneeKC-1102LKC-1102L2015-11-27
00841690100836APEX CR KneeKC-1102RKC-1102R2015-11-27
00841690100843APEX CR KneeKC-1103LKC-1103L2015-11-27
00841690100850APEX CR KneeKC-1103RKC-1103R2015-11-27
00841690100867APEX CR KneeKC-1104LKC-1104L2015-11-27
00841690100874APEX CR KneeKC-1104RKC-1104R2015-11-27
00841690100881APEX CR KneeKC-1105LKC-1105L2015-11-27
00841690100898APEX CR KneeKC-1105RKC-1105R2015-11-27
00841690100904APEX CR KneeKC-1106LKC-1106L2015-11-27
00841690100911APEX CR KneeKC-1106RKC-1106R2015-11-27
00841690100928APEX CR KneeKC-1125LKC-1125L2015-11-27
00841690100935APEX CR KneeKC-1125RKC-1125R2015-11-27
00841690100942APEX CR KneeKC-1135LKC-1135L2015-11-27
00841690100959APEX CR KneeKC-1135RKC-1135R2015-11-27
00841690100966APEX CR KneeKC-1145LKC-1145L2015-11-27
00841690100973APEX CR KneeKC-1145RKC-1145R2015-11-27
00841690101000OMNI KneeKC-2201LKC-2201L2015-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327670936TriathlonHowmedica Osteonics Corp.MBH2026-02-26
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07613327671032TriathlonHowmedica Osteonics Corp.MBH2026-02-26
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07613327671094TriathlonHowmedica Osteonics Corp.MBH2026-02-26
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07613327671131TriathlonHowmedica Osteonics Corp.MBH2026-02-26
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07613327671186TriathlonHowmedica Osteonics Corp.MBH2026-02-26
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07613327671278TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671285TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671315TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671322TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671346TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671377TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671384TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671407TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671421TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671445TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671469TriathlonHowmedica Osteonics Corp.MBH2026-02-26
07613327671483TriathlonHowmedica Osteonics Corp.MBH2026-02-26