10mm Twist Subtalar Implant

FDA UDI

Class II (US FDA UDI)

by Trilliant Surgical LLC

Identity

Trade Name: 10mm Twist Subtalar Implant FDA UDI
Generic Name: Subtalar implant, non-bioabsorbable FDA UDI
Model / Reference: 102-10-010 FDA UDI

Identifiers

Primary DI / UDI-DI: 00812926020266 FDA UDI
510(k) Number: K103183 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Subtalar implant, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 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

Dimensions & Sizes

Size: Width — 10.0 Millimeter FDA UDI
Height — 15 Millimeter FDA UDI

Category: Subtalar implant, non-bioabsorbable

10mm Twist Subtalar Implant by Trilliant Surgical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Subtalar implant, non-bioabsorbable.

HORIZON HYBRID SUBTALAR 12MM — BIOPRO, INC. · Class II
HORIZON SUBTALAR GEN 2 10MM — BIOPRO, INC. · Class II
Subtalar MBA Implant System — Smith & Nephew, Inc. · Class II
LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC · Class II
HyProCure II Sinus Tarsi Stent Size 06 — Gramedica · Class II
HORIZON TITANIUM SUBTALAR 12MM — BIOPRO, INC. · Class II
HORIZON TITANIUM SUBTALAR 6MM — BIOPRO, INC. · Class II
bioBLOCK® Subtalar Implant System — Ascension Orthopedics, Inc. · Class II

Cleared under the same submission

K103183 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 971114dd-1ef7-4f2d-a163-4f89bb25ed67 34 fields · synced May 30, 2026