3S Hemi

FDA UDI

Class II (US FDA UDI)

by Trilliant Surgical LLC

Identity

Trade Name: 3S Hemi FDA UDI
Generic Name: Partial metatarsophalangeal joint prosthesis FDA UDI
Device Name: 3S Hemi Implant, Small, Non-Sterile FDA UDI
Model / Reference: 101-00-001 FDA UDI
Description: 3S Hemi Implant, Small, Non-Sterile FDA UDI

Identifiers

Primary DI / UDI-DI: 00812926020075 FDA UDI
510(k) Number: K072922 FDA UDI
FDA Product Code: KWD FDA UDI
GMDN Term: Partial metatarsophalangeal joint prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Partial metatarsophalangeal joint prosthesis

3S Hemi by Trilliant Surgical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Partial metatarsophalangeal joint prosthesis.

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TOE NON POROUS COATED SMALL 17mm — BIOPRO, INC. · Class II
Accu-Joint — ACCUFIX SURGICAL, INC. · Class II
OsteoMed — Osteomed Corp. · U
Arthrex® — Arthrex, Inc. · Class II
MDI — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II

Cleared under the same submission

K072922 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Trilliant Surgical LLC

Sources (1)

FDA UDI e6e2f6d0-e3c0-401e-96f7-01d467e94889 34 fields · synced May 30, 2026