Osteonics Alumina C-Taper Head, Trident Polyethylene Inserts

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts

Trade Name

Trident EUDAMED

Instrument GUDID

Generic Name

Instrument tray, reusable

Acetabulum prosthesis trial, prefabricated, reusable

Device Name

TF-025 - Class IIa - Hip - Trial Insert

TF-018 Class I - Cases/Trays/Bowles

Model / Ref / Catalog

6147-3-105, 2210-26H, 08858251005231SU, 08858250000817SC

Primary DI / UDI-DI

07613327116793, 07613327214642

Basic UDI-DI

08858251005231SU, 08858250000817SC

Direct Marketing DI

07613327214642

07613327116793

510(k) Number

K991952 ↗

FDA Product Code

LZO, FSM, LWJ, KWY, KWL, MEH, JDI, MAY, MBL, LPH, KWZ, HWC

EMDN Code

V06010101, V0402

GMDN Term

Instrument tray, reusable

Acetabulum prosthesis trial, prefabricated, reusable

Device Class

Class I EUDAMEDGUDID

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 888.3353 510(k)GUDID

878.4800 GUDID

888.3360 GUDID

888.3390 GUDID

888.3350 GUDID

888.3358 GUDID

888.3310 GUDID

888.3040 GUDID

EU market of registration

Netherlands

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

Size

Lumen/Inner Diameter — 26.0 Millimeter

• Custom / Specialty

  Class IIa

  CE/MDR

• Exeter

  Class III

  CE/MDR MDR 730293 Expiring Valid to Oct 2027

• Mrh

  Class I

  CE/MDR

• Instrument

  Class I

  CE/MDR

• Trident 625-0T-36I

  Class III

  GUDID on market

• Trident 625-0T-28D

  Class III

  GUDID on market

See all devices from Howmedica Osteonics Corp. →

• What types of hip replacement surgeries are these components intended for use in?

  These components are designed specifically for total hip arthroplasty, where the alumina head articulates with compatible polyethylene acetabular cup liners to create a durable bearing surface. They are part of a matched set for surgical use in orthopedic hip replacement procedures, pairing with Trident polyethylene inserts that fit within an acetabular shell.

• Are these components single-use or reusable, and what about sterility?

  The provided data does not specify whether these components are single-use or reusable, nor does it mention sterility requirements. Clinicians should follow the manufacturer’s instructions for use (IFU) or facility protocols to determine proper handling and reprocessing if applicable.

• How are the alumina head and Trident polyethylene inserts paired, and do they come in multiple sizes?

  The alumina head is supplied as a matched set with Trident polyethylene inserts, meaning each head is designed to pair with a specific acetabular cup system. Sizes and configurations are determined by the matching acetabular shell, so compatibility depends on the surgical plan and the cup system being used.

• What regulatory pathways have these components gone through, and how does that affect their use?

  These components received FDA 510(k) clearance (K991952) under the Orthopedic advisory committee and are also compliant with MDR requirements. The clearance indicates they are considered substantially equivalent to a predicate device, but clinicians should confirm the latest regulatory status and follow the manufacturer’s guidelines for proper use.