FDA.reportPublic FDA data

AP Sizer with Short Legs

Primary DI
00810094692940
Brand
AP Sizer with Short Legs
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
SRI-10050
Device description
AP Sizer with Short Legs
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094692940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094692940008100946929408100946929400810094692940

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The Klassic Knee System should be stored in a clean, dry location at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)486-6070kcardall@tjoinc.com

Regulatory Flags#

DUNS number
078416717
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094692803Klassic Blade Femoral Broach, Line-To-Line, size 0SRI-10054.002026-07-27
00810094692810Klassic Blade Femoral Broach, Line-To-Line, size 1SRI-10054.012026-07-27
00810094692827Klassic Blade Femoral Broach, Line-To-Line, size 2SRI-10054.022026-07-27
00810094692834Klassic Blade Femoral Broach, Line-To-Line, size 3SRI-10054.032026-07-27
00810094692841Klassic Blade Femoral Broach, Line-To-Line, size 4SRI-10054.042026-07-27
00810094692858Klassic Blade Femoral Broach, Line-To-Line, size 5SRI-10054.052026-07-27
00810094692865Klassic Blade Femoral Broach, Line-To-Line, size 6SRI-10054.062026-07-27
00810094692872Klassic Blade Femoral Broach, Line-To-Line, size 7SRI-10054.072026-07-27
00810094692889Klassic Blade Femoral Broach, Line-To-Line, size 8SRI-10054.082026-07-27
00810094692896Klassic Blade Femoral Broach, Line-To-Line, size 9SRI-10054.092026-07-27
00810094692902Klassic Blade Femoral Broach, Line-To-Line, size 10SRI-10054.102026-07-27
00810094692919Klassic Blade Femoral Broach, Line-To-Line, size 11SRI-10054.112026-07-27
00810094692926Klassic Blade Femoral Broach, Line-To-Line, size 12SRI-10054.122026-07-27
00810094692698Modular Frog Eyes2263.00.0002026-06-09
00810094692704Distal Femoral Cut Block Connector2174.00.0002026-06-09
00810094692797Tibial Reamer, Square Tip, Klassic ONE 25/50mm2264.00.0002026-06-09
00810094692933Magnet Spacer, 5mm2027.00.0002026-06-09
00810094692728CR Femoral Trial, Grit BlastedSRI-10051.012026-02-05
00810094692735CR Femoral Trial, Grit BlastedSRI-10051.022026-02-05
00810094692742CR Femoral Trial, Grit BlastedSRI-10051.032026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841523183081Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523183746Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185030Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185047Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185054Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185061Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185078Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185092Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185108Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185139Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185146Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185153Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185160Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185177Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185382Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
B382SD484620Surgical DirectSurgical Direct, Inc.LXH2026-08-07
M7409200004MIS TLIF SystemSPINEOLOGY INC.LXH2026-08-07
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31