FDA.reportPublic FDA data

SCREW SYSTEM

Primary DI
00880304213951
Brand
SCREW SYSTEM
Company
Biomet Orthopedics, LLC
Model
113845
Catalog number
113845
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
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030710000
K872454000
K991807000
K992119000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030710000BIO-MODULAR SHOULDER SYSTEMBiomet, Inc.2003-06-04KWT
K872454000BIOMET MODULAR SHOULDER PROSTHESISBiomet, Inc.1987-08-27KWT
K991807000TITANIUM LOW PROFILE SCREWSBiomet, Inc.1999-07-08LPH
K992119000BIO-MODULAR SHOULDER SYSTEMBiomet, Inc.1999-09-13KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304213951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304213951008803042139518803042139510880304213951

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement spacerA prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device.

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
00840097513201Velora Acetabular System InstrumentationRestor3d, Inc.LPH2026-08-21
00840097536675Velora Acetabular System InstrumentationRestor3d, Inc.LPH2026-08-19
05404028001028SurgiCase PlannerMaterialise NVKWS2025-08-28
08033390201858Smart SPACE SHOULDERLIMACORPORATE SPAMBF2023-02-18
08033390201858Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390201872Smart SPACE SHOULDERLIMACORPORATE SPAMBF2023-02-18
08033390201872Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390201896Smart SPACE SHOULDERLIMACORPORATE SPAMBF2023-02-18
08033390201896Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390201919Smart SPACE SHOULDERLIMACORPORATE SPAMBF2023-02-18
08033390201919Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390201933Smart SPACE SHOULDERLIMACORPORATE SPAMBF2023-02-18
08033390201933Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390201957Smart SPACE SHOULDERLIMACORPORATE SPAMBF2023-02-18
08033390201957Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390239509Smart SPACE SHOULDERLIMACORPORATE SPAMBF2023-02-18
08033390239509Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390239516Smart SPACE SHOULDERLIMACORPORATE SPAMBF2023-02-18
08033390239516Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
10885862013743NAExactech, Inc.LPH2022-09-20
10885862013750NAExactech, Inc.LPH2022-09-20
10885862022448NAExactech, Inc.LPH2022-09-19
10885862022455NAExactech, Inc.LPH2022-09-19
10885862029867NAExactech, Inc.LPH2022-09-19
10885862010551NAExactech, Inc.LPH2022-08-18
10885862010575NAExactech, Inc.LPH2022-08-18
10885862010582NAExactech, Inc.LPH2022-08-18
10885862010872NAExactech, Inc.LPH2022-08-18
10885862010889NAExactech, Inc.LPH2022-08-18
10885862010896NAExactech, Inc.LPH2022-08-18