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
| Manufacturer | Southern Implants (Pty) LtdManufacturer-reported[1][2] |
|---|---|
| Body geometry | Several 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] |
| Material | Manufacturer documentation not located |
| Surface | Machined 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] |
| Connection | Requires manual verification(The catalogue lists several internal configurations across the zygomatic range; we have not resolved which connection belongs to each item code.) |
| Available diameters | Manufacturer documentation not located |
| Available lengths | ZYGAN, 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
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.
Further detail
| Geographic availability | Requires 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.
| Number | Device | Holder | Date |
|---|---|---|---|
| 3003394627 | — | SOUTHERN IMPLANTS (PTY) LTD | — |
| 954 device records | — | Southern 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.
| Number | Device | Holder | Date |
|---|---|---|---|
| K191054 | Southern Implants MAX Implant System | Southern 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
- [1]Zygomatic Implants Product Catalogue (CAT-2070) — Southern Implants (Pty) Ltd. Accessed 2026-07-21.
- [2]Profile — Southern Implants — Southern Implants (Pty) Ltd. Accessed 2026-07-21.