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ZimVie TSX

Also known as: TSX, TSX Implant System

A ZimVie tapered implant with a double-lead thread, an MTX surface below a 1.5 mm dual acid-etched coronal zone, and a conical hex or internal hex connection depending on platform.

Quick facts

Current statusCurrent. ZimVie publishes a TSX product catalogue.Manufacturer-reported[1]
Implant levelBone level. ZimVie states that TSX implants are designed to be placed at bone level or slightly below the crest of the bone, and captions the range "Bone-Level Implants".Manufacturer-reported[2]
Body geometryTapered body with a defined apex diameter for each body diameter: ∅ 2.7 mm apex on the ∅ 3.1 mm implant, 3.0 on 3.7, 3.7 on 4.1, 4.0 on 4.7, 4.7 on 5.4 and 5.4 on 6.0 mm.Manufacturer-reported[1]
Thread designDouble lead thread.Manufacturer-reported[1]
Apex designThe catalogue specifies an apex diameter for every body diameter, from ∅ 2.7 mm to ∅ 5.4 mm.Manufacturer-reported[1]
MaterialNot publicly verified(The TSX product catalogue (ZVINST0019) and the TSX surgical manual (ZVINST0015) both state materials for instruments — drill stops in Grade 5 titanium alloy, guided-surgery fixation pins in TiAl6V4 to ASTM F136 — but neither states the substrate of the implant body, and ZimVie's TSX product pages do not either. Both documents refer the reader to the ZimVie Dental Implant IFU (P-IIS086GI), which is issued only through the labeling.zimvie.com request portal and could not be retrieved.)
SurfaceMTX surface on the body with a 1.5 mm dual acid-etched coronal zone.Manufacturer-reported[1]
ConnectionThe ∅ 2.9 mm NP platform uses a 2.1 mm conical hex; the ∅ 3.5 mm and ∅ 4.5 mm platforms use a 2.5 mm internal hex.Manufacturer-reported[1]
Platform switchingEvery body diameter is mounted on a narrower platform: ∅ 3.1 mm body on a ∅ 2.9 mm platform, ∅ 3.7, 4.1 and 4.7 mm bodies on a ∅ 3.5 mm platform, and ∅ 5.4 and 6.0 mm bodies on a ∅ 4.5 mm platform.Manufacturer-reported[1]
Available diameters∅ 3.1, 3.7, 4.1, 4.7, 5.4 and 6.0 mm.Manufacturer-reported[1]
Available lengths8, 10, 11.5, 13 and 16 mm across all six diameters.Manufacturer-reported[1]

Overview

TSX is ZimVie’s more recent tapered implant and is easiest to understand as a redesign of Tapered Screw-Vent for immediate placement, with a double-lead thread and a drilling protocol that branches by bone type rather than by diameter alone. The catalogue is explicit that the colour coding differs from TSV — the ∅ 4.7 mm TSX sits on a green ∅ 3.5 mm platform and the ∅ 6.0 mm on a purple ∅ 4.5 mm platform, which is not how the older system is coded — so the two ranges should not be cross-read. Only the narrow ∅ 3.1 mm implant uses the 2.1 mm conical hex; everything above it takes the same 2.5 mm internal hex, which keeps the component count low. As with TSV, ZimVie does not state the substrate material in the catalogue reviewed.

Technology

Clinical positioning

What the manufacturer says this system is designed for. This is not the same thing as independent clinical evidence, which is set out separately below.

ZimVie provides separate final drills for extraction, soft bone and dense bone placement, marked E, S and D.Manufacturer-reported

Clinical evidence

We have not yet completed a system-specific evidence review for ZimVie TSX. Insufficient system-specific evidence How we grade evidence

Similar implant systems

Popular comparisons

The clearances below are held by ZimVie Dental at brand level and cover its implant range, not ZimVie TSX specifically. We show them here because that is the level at which regulators actually issue them.

Regulatory record

Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →

Other5 records

Registered device establishment in United States. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.

NumberDeviceHolderDate
1038806ZimVie US Corp LLC
1000244346ZimVie Canada Inc.
3009840806ZimVie Spain S.L.U.
3006411780ZimVie Spain S.L.U.
1492 device recordsZimVie Dental

Clearance records for ZimVie Dental were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to ZimVie Dental.

Sources

Numbers match the citations beside each claim above.

Primary sources

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