FDA.reportPublic FDA data

TSI Stem Trial

Primary DI
09348215040604
Brand
TSI Stem Trial
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
111-23-3050
Published
2018-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWTTemplate
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181340000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181340000Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.2019-02-11JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215040604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215040604093482150406049348215040604

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. 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
09348215199890Triple Taper Stem Standard Offset Collared Size 069-00112026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 069-00122026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 069-00212026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 069-00222026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 169-01112026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 169-01122026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 169-01212026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 169-01222026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 269-02112026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 269-02122026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 269-02212026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 269-02222026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 369-03112026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 369-03122026-09-22
09363272000033Triple Taper Stem Standard Offset Collarless Size 369-03212026-09-22
09363272000040Triple Taper Stem High Offset Collarless Size 369-03222026-09-22
09363272000057Triple Taper Stem Standard Offset Collared Size 469-04112026-09-22
09363272000064Triple Taper Stem High Offset Collared Size 469-04122026-09-22
09363272000071Triple Taper Stem Standard Offset Collarless Size 469-04212026-09-22
09363272000088Triple Taper Stem High Offset Collarless Size 469-04222026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606197472OMEGA XPSPINAL ELEMENTS, INC.LXH2026-10-29
00842078100219HammerFiXEXTREMITY MEDICAL, LLCLXH2026-10-29
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00842078100486XMCPEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078112410Axis BeamsEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078116197AlignXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078123584KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124185Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124215Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129609KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129616KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129623KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129753IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129777IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129784IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129791IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
04250337122432iLESSYS® Interlaminar Endoscopic Surgical SystemJoimax GmbHLXH2026-10-29
04260056885877InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885891InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885914InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885938InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885952InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885976InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885990InterSpace® Hip Mold Trial Head 42 mmOSARTIS GmbHHWT2026-10-29
04260056886010InterSpace® Hip Mold Trial Head 48 mmOSARTIS GmbHHWT2026-10-29
04260056886034InterSpace® Hip Mold Trial Head 52 mmOSARTIS GmbHHWT2026-10-29
04260056886058InterSpace® Hip Mold Trial Head 56 mmOSARTIS GmbHHWT2026-10-29
04260056886072InterSpace® Hip Mold Trial Head 60 mmOSARTIS GmbHHWT2026-10-29
04260056886096InterSpace® Knee Mold Trial Femoral Component XSOSARTIS GmbHHWT2026-10-29