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Southern Implants Zygomatic range

Also known as: ZYGAN, ZYGEX, ZYGIN, ZYGON, ONC-55, Southern zygomatic implant

A family of zygomatic implants from Southern Implants, made in lengths from 27.5 mm to 60 mm and finished with a machined coronal surface, for maxillae too resorbed for conventional implants.

Quick facts

ManufacturerSouthern Implants (Pty) LtdManufacturer-reported[1][2]
Body geometrySeveral head and apex designs: ZYGAN, ZYGEX, ZYGIN, ZYGIN-W, ZYGON and ONC-55, with ZYGIN, ZYGIN-W and ZYGON carrying a narrower fixture mount and implant head for the severely atrophic maxilla, and ZYGIN-W a wider apical region where primary stability is lackingManufacturer-reported[1]
MaterialManufacturer documentation not located
SurfaceMachined Surface Coronally (MSC) — a machined coronal portion combined with a moderately rough surface elsewhere, which Southern indicates for patients at higher risk of coronal bone lossManufacturer-reported[1]
ConnectionRequires manual verification(The catalogue lists several internal configurations across the zygomatic range; we have not resolved which connection belongs to each item code.)
Available diametersManufacturer documentation not located
Available lengthsZYGAN, ZYGEX, ZYGIN, ZYGIN-W and ZYGON in 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5 and 60 mm; ONC-55 in 27.5, 32.5, 37.5, 42.5 and 47.5 mmManufacturer-reported[1]

Overview

Southern Implants is one of the few manufacturers whose catalogue is organised around difficult anatomy rather than around a single flagship implant, and its zygomatic range is the clearest example: six named designs differing mainly in head shape and apical form, in thirteen lengths from 30 mm to 60 mm. Some are specifically for maxillectomy and oncological cases rather than for age-related resorption. The surface treatment is also unusual in being deliberately mixed — machined at the coronal end, roughened below — on the reasoning that the crestal part of a zygomatic implant is often not surrounded by good bone. This is specialist surgery with its own complication profile, and the length of the implant is a consequence of the anatomy, not a measure of how substantial the treatment is.

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.

Indicated for severely atrophic maxillae and, in the case of ONC-55, ZYGEX and ZYGON, for oncological resections and maxillectomy cases; several designs are described as suited to the quad protocol of two implants per zygomaManufacturer-reported

Further detail

Geographic availabilityRequires manual verification

Clinical evidence

We have not yet completed a system-specific evidence review for Southern Implants Zygomatic range. Insufficient system-specific evidence How we grade evidence

Similar implant systems

The clearances below are held by Southern Implants at brand level and cover its implant range, not Southern Implants Zygomatic range 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 →

Other2 records

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

NumberDeviceHolderDate
3003394627SOUTHERN IMPLANTS (PTY) LTD
954 device recordsSouthern Implants

FDA 510(k) clearance1 record

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

NumberDeviceHolderDate
K191054Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd.2019-12-09

Clearance records for Southern Implants 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 Southern Implants.

Sources

Numbers match the citations beside each claim above.

Primary sources

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