FDA.reportPublic FDA data

Signature ONE Software Package

Primary DI
00889024707047
Brand
Signature ONE Software Package
Company
Orthosoft Inc
Model
302.4018
Catalog number
302.4018
Published
2026-07-10
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

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
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
PHXshoulder prosthesis, reverse configuration
QHEShoulder arthroplasty implantation system

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
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2
QHEShoulder Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261510000Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS2026-06-04QHE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024707047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024707047008890247070478890247070470889024707047

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical planning radiology softwareA software program intended to display and analyse/process images of a limb bone(s), rib(s), the sternum and/or pelvis (excludes craniofacial and spinal), primarily to assist with the planning of an orthopaedic surgical procedure (typically manual or robotic-assisted arthroplasty). The images are typically acquired via x-ray [e.g., computed tomography (CT)]. It may include a library of three-dimensional (3D) implants intended to facilitate planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
+1(866)336-7846zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
205670032
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868552120ROSA®20-8020-158-0020-8020-158-002023-04-10
00887868558146ROSA® Shoulder20-8087-302-00208087302002024-03-06
00887868580963ROSA® Shoulder20-8087-506-00208087506002024-03-06
00887868554391Signature™ Comprehensive®20-8090-009-0120-8090-009-012024-02-09
00887868554407Signature™ Comprehensive®20-8090-009-0220-8090-009-022024-02-09
00887868552205ROSA® Knee20-8020-191-0020-8020-191-002022-10-20
00889024563636Sesamoid ®20-8000-000-1120-8000-000-112021-01-28
00889024304079Trabecular Metal20-8075-004-0220-8075-004-022016-09-12
00889024304307ROSA® Robotics20-8000-010-0620-8000-010-062016-09-07
00889024304406ROSA® Robotics20-8000-010-1720-8000-010-172016-09-07
00889024304413Optical20-8000-010-1820-8000-010-182016-09-12
00889024304567ROSA® Robotics20-8000-010-3320-8000-010-332016-09-12
00889024304871Optical20-8000-020-1320-8000-020-132016-09-12
00889024304895Optical20-8000-020-1520-8000-020-152016-09-12
00889024304956Optical20-8000-020-2120-8000-020-212016-09-12
00889024305397iASSIST20-8011-040-0020-8011-040-002016-09-07
00889024305748Signature ONE20-8070-009-002017-06-13
00889024305762PSI Knee20-8070-010-022017-09-28
00889024486638X-PSI™20-8085-020-0020-8085-020-002018-04-18
00889024563391Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left20-8090-004-0120-8090-004-012019-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097503677Veritas InstrumentationRestor3d, Inc.PHX2026-10-16
00887868554391Signature™ Comprehensive®Orthosoft IncPHX2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncMBF2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncQHE2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncMBF2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncPHX2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncQHE2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868522987Signature ONEOrthosoft IncPHX2022-07-20
00887868522987Signature ONEOrthosoft IncQHE2022-07-20
00887868522987Signature ONEOrthosoft IncKWS2022-07-20
00887868522987Signature ONEOrthosoft IncHSD2022-07-20
00887868522987Signature ONEOrthosoft IncKWT2022-07-20
00887868522987Signature ONEOrthosoft IncMBF2022-07-20
00887868522994Signature ONEOrthosoft IncQHE2022-07-20
00887868522994Signature ONEOrthosoft IncKWS2022-07-20
00887868522994Signature ONEOrthosoft IncKWT2022-07-20
00887868522994Signature ONEOrthosoft IncHSD2022-07-20
00887868522994Signature ONEOrthosoft IncPHX2022-07-20
00887868522994Signature ONEOrthosoft IncMBF2022-07-20
00889024647046Signature ONE Software PackageOrthosoft IncHSD2022-07-05
00889024647046Signature ONE Software PackageOrthosoft IncKWS2022-07-05
00889024647046Signature ONE Software PackageOrthosoft IncPHX2022-07-05
00889024647046Signature ONE Software PackageOrthosoft IncMBF2022-07-05
00889024647046Signature ONE Software PackageOrthosoft IncKWT2022-07-05