FDA.reportPublic FDA data

STAR PSI Tibia Anatomical Model

Primary DI
00810028393448
Brand
STAR PSI Tibia Anatomical Model
Company
Trilliant Surgical, LLC
Model
601-01-001
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NTGProsthesis, Ankle, Uncemented, Non-Constrained

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTGProsthesis, Ankle, Uncemented, Non-ConstrainedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P050050023

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050050023SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)Djo Global2009-05-27NTG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810028393448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028393448008100283934488100283934480810028393448

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828829072
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446898801Arsenal Foot330-60-0062026-03-19
00810028397385Tiger201-30-0422024-06-04
00810028399099Tiger201-40-2102024-06-04
00810028399464Tiger203-20-0162024-06-04
00850062461949Tibial Impactor Tips 920-0061-042024-08-09
00810028391840Arsenal Ankle340-00-0032022-05-02
00812926028804Hook Tamp320-00-0202019-03-11
008129260201293S Hemi111-00-0022018-09-23
008129260202283S Hemi111-00-0122018-09-23
00812926027043Two-Step Hammertoe214-00-0142018-09-23
008129260280333S Hemi111-00-0132018-09-23
00812926028187Staple Tamp510-00-0052018-09-23
00810028398344Tiger201-20-0082024-05-31
00810028395343Arsenal Foot300-82-0252024-03-27
00810028395206Arsenal Foot300-82-0112024-03-21
00810028395213Arsenal Foot300-82-0122024-03-21
00810028395220Arsenal Foot300-82-0132024-03-21
00810028395237Arsenal Foot300-82-0142024-03-21
00810028395244Arsenal Foot300-82-0152024-03-21
00810028395251Arsenal Foot300-82-0162024-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850062461949Tibial Impactor Tips Trilliant Surgical, LLCNTG2024-08-09
008100283934796mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
008100283934867mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
008100283934938mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
008100283935099mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839351610mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839352311mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839353012mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839354713mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839355414mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0085006246136914mm E+ Slide Core STAR ImplantTrilliant Surgical, LLCNTG2024-08-06
B095301201Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301202Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301203Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301204Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301205Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301206Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
00810028393431STAR PSI Tibia Cut GuideTrilliant Surgical, LLCNTG2022-11-30
00810028393455STAR PSI Talus Cut GuideTrilliant Surgical, LLCNTG2022-11-30
00810028393462STAR PSI Talus Anatomical ModelTrilliant Surgical, LLCNTG2022-11-30
00810028394971STAR PSI Standard Bundle with Anatomical ModelsTrilliant Surgical, LLCNTG2022-11-30
00886385017365STARStryker GmbHNTG2022-02-14
00886385018836STARStryker GmbHNTG2022-02-14
00886385018843STARStryker GmbHNTG2022-02-14
00886385019055STARStryker GmbHNTG2022-02-14
00886385019062STARStryker GmbHNTG2022-02-14
00886385019147STARStryker GmbHNTG2022-02-14
B095302113Hintermann Series H3Dt Medtech, LLCNTG2019-08-20
B095302125Hintermann Series H3Dt Medtech, LLCNTG2019-08-20
B095300506Hintermann Series H3Dt Medtech, LLCNTG2019-08-20