FDA.reportPublic FDA data

StageOne™

Primary DI
00887868543227
Brand
StageOne™
Company
Biomet Orthopedics, LLC
Model
431414
Catalog number
431414
Published
2022-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
MBBBONE CEMENT, ANTIBIOTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
MBBBone Cement, AntibioticOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131135000
K160071000
K221968000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131135000BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESISBiomet Manufacturing Corp2014-01-22MBB
K160071000StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.2016-06-16MBB
K221968000StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.2022-09-15MBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868543227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868543227008878685432278878685432270887868543227

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement spacer mouldA moulding device designed to form an implantable provisional joint prosthesis component out of orthopaedic cement (otherwise known as a cement spacer), which is used in two-stage joint revision typically to treat joint arthroplasty infection. It is filled with prepared antibiotic-containing bone cement which cures into the shape of the prosthesis and is subsequently placed into the joint space until replaced with a revision joint prosthesis. It is typically made of silicone and available in a variety of shapes and sizes for different joint applications. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
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
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24
00888480584575PRO OSTEON 5005G055G052015-10-24
00888480584582PRO OSTEON 5005G105G102015-10-24
00888480584599PRO OSTEON 5005G155G152015-10-24
00888480584629PRO OSTEON 5005G305G302015-10-24
00888480584681PRO OSTEON 500R5RB0105RB0102015-10-24
00888480584698PRO OSTEON 500R5RB0145RB0142015-10-24
00888480584704PRO OSTEON 500R5RB0245RB0242015-10-24
00888480584711PRO OSTEON 500R5RB0405RB0402015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542795602Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795817Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795824Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795831Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795848Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795855Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795879Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSHSD2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-09-22
00840097533919Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncHSD2026-07-10
00887868554391Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-13
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-13
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810071AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810071AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08
00885556810125AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810125AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08