FDA.reportPublic FDA data

Origin TT Stem, Broach, Size 2

Primary DI
09348215137724
Brand
Origin TT Stem, Broach, Size 2
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
591-002
Published
2025-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243029000Origin™ TT StemSignature Orthopaedics Pty, Ltd.2025-03-11LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215137724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215137724093482151377249348215137724

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
751993028
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215019587Evolve AP Cup - Size 28-40111-17-40282026-06-26
09348215019594Evolve AP Cup - Size 28-42111-17-42282026-06-26
09348215019600Evolve AP Cup - Size 28-44111-17-44282026-06-26
09348215019617Evolve AP Cup - Size 28-46111-17-46282026-06-26
09348215019624Evolve AP Cup - Size 28-48111-17-48282026-06-26
09348215019631Evolve AP Cup - Size 28-50111-17-50282026-06-26
09348215019648Evolve AP Cup - Size 28-52111-17-52282026-06-26
09348215019655Evolve AP Cup - Size 28-54111-17-54282026-06-26
09348215019662Evolve AP Cup - Size 28-56111-17-56282026-06-26
09348215046019World Knee Cemented Titanium Tibial Plate - Modular - Size 1 - 40mm121-20-41202026-06-26
09348215046026World Knee Cemented Titanium Tibial Plate - Modular - Size 2 - 40mm121-20-42202026-06-26
09348215046033World Knee Cemented Titanium Tibial Plate - Modular - Size 3 - 40mm121-20-43202026-06-26
09348215046040World Knee Cemented Titanium Tibial Plate - Modular - Size 4 - 40mm121-20-44202026-06-26
09348215046057World Knee Cemented Titanium Tibial Plate - Modular - Size 5 - 40mm121-20-45202026-06-26
09348215046064World Knee Cemented Titanium Tibial Plate - Modular - Size 6 - 40mm121-20-46202026-06-26
09348215046071World Knee Cemented Titanium Tibial Plate - Modular - Size 7 - 40mm121-20-47202026-06-26
09348215046088World Knee Cemented Titanium Tibial Plate - Modular - Size 8 - 40mm121-20-48202026-06-26
09348215046095World Knee Cemented Titanium Tibial Plate - Modular - Size 9 - 40mm121-20-49202026-06-26
09348215148980Evolve AP Vit-E Cup – Neutral - Size 32-46111-17-01462026-06-26
09348215148997Evolve AP Vit-E Cup – Neutral - Size 32-48111-17-01482026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150002139N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00199150002146N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754730N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754747N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00822409082124N/AOrtho Development CorporationLXH2026-07-16
00822409082131N/AOrtho Development CorporationLXH2026-07-16
00822409082148N/AOrtho Development CorporationLXH2026-07-16
00822409082155N/AOrtho Development CorporationLXH2026-07-16
00822409082162N/AOrtho Development CorporationLXH2026-07-16
00822409082179N/AOrtho Development CorporationLXH2026-07-16
00822409082186N/AOrtho Development CorporationLXH2026-07-16
00822409082193N/AOrtho Development CorporationLXH2026-07-16
00822409082209N/AOrtho Development CorporationLXH2026-07-16
00822409082216N/AOrtho Development CorporationLXH2026-07-16
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00822409082254N/AOrtho Development CorporationLXH2026-07-16
00822409082261N/AOrtho Development CorporationLXH2026-07-16
00822409082278N/AOrtho Development CorporationLXH2026-07-16
00822409082285N/AOrtho Development CorporationLXH2026-07-16
00822409082292N/AOrtho Development CorporationLXH2026-07-16
00822409082308N/AOrtho Development CorporationLXH2026-07-16
00822409082315N/AOrtho Development CorporationLXH2026-07-16
00822409082322N/AOrtho Development CorporationLXH2026-07-16
00822409082339N/AOrtho Development CorporationLXH2026-07-16
00822409082346N/AOrtho Development CorporationLXH2026-07-16
00840606188135Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188142Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188159Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16