FDA.reportPublic FDA data

ASCENT KNEE SYSTEM

Primary DI
00880304262690
Brand
ASCENT KNEE SYSTEM
Company
Biomet Orthopedics, LLC
Model
179116
Catalog number
179116
Published
2015-10-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWHPROSTHESIS, TOE, CONSTRAINED, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWHProsthesis, Toe, Constrained, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994326000ASCENT KNEE SYSTEMBiomet Manufacturing, Inc.2000-01-07KWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304262690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304262690008803042626908803042626900880304262690

GMDN Terms#

Term, Definition table
TermDefinition
Knee arthroplasty wedgeA sterile device designed to augment the implantation of a knee femur or tibia prosthesis by acting as a space-filler adjacent to the prosthesis, typically to replace lost bone. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819034029181Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00819034029198Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00819034029211Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00840124507456Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00840124508989Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00885556834244Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834268Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834282Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834305Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834329Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834374Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834398Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834411Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834435Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834534Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834558Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834572Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834596Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
08057717550801Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550818Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550825Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550832Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550849Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550856Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550863Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550870Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550887Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550894Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
00840124506138Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2021-08-18
00840124506145Sgarlato Silastic FUSION ORTHOPEDICS, LLCKWH2021-08-18