FDA.reportPublic FDA data

TiLock

Primary DI
M719GSIX1210
Brand
TiLock
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GSI-X121
Device description
SIros-X Rod Rocker
Published
2026-08-18
Public version status
New
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
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252322000SIros-X SystemGenesys Spine2025-10-22OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719GSIX1210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
512-381-7070info@genesysspine.com

Regulatory Flags#

DUNS number
017921066
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M719IST80030C0TiLock1IS-T80030-C2026-08-18
M719IST80035C0TiLock1IS-T80035-C2026-08-18
M719IST80040C0TiLock1IS-T80040-C2026-08-18
M719IST80045C0TiLock1IS-T80045-C2026-08-18
M719IST80050C0TiLock1IS-T80050-C2026-08-18
M719IST80055C0TiLock1IS-T80055-C2026-08-18
M719IST80060C0TiLock1IS-T80060-C2026-08-18
M719IST80065C0TiLock1IS-T80065-C2026-08-18
M719IST80070C0TiLock1IS-T80070-C2026-08-18
M719IST80075C0TiLock1IS-T80075-C2026-08-18
M719IST80080C0TiLock1IS-T80080-C2026-08-18
M719IST80085C0TiLock1IS-T80085-C2026-08-18
M719IST80090C0TiLock1IS-T80090-C2026-08-18
M719IST80095C0TiLock1IS-T80095-C2026-08-18
M719IST80100C0TiLock1IS-T80100-C2026-08-18
M719IST80105C0TiLock1IS-T80105-C2026-08-18
M719IST80110C0TiLock1IS-T80110-C2026-08-18
M719IST80115C0TiLock1IS-T80115-C2026-08-18
M719IST80120C0TiLock1IS-T80120-C2026-08-18
M719IST80125C0TiLock1IS-T80125-C2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719G120050SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120060SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120070SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120080SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120090SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120100SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120110SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120120SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120130SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120000SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120010SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120020SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120030SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120040SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOUR2026-07-23
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-07-17
18257200140084Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200140091Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143368Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143375Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143382Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143399Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143405Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143412Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143429Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143436Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143443Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143450Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200146079Firebird SI FusionOrthofix US LLCOUR2026-07-17