Southern Implants

Also known as: Southern Implants (Pty) Ltd, SInergy

The implant brand of the South African manufacturer Southern Implants, known for site-specific designs including zygomatic and pterygoid implants.

Key facts

Manufacturer	Southern Implants (Pty) LtdVerified spec[1]
Parent company	Southern Implants (Pty) Ltd, privately ownedVerified spec[1]
Country	South AfricaVerified spec[1]
Headquarters	1 Albert Road, Irene, South AfricaVerified spec[1]
Founded	1987, by the engineer Graham BlackbeardVerified spec[1]
Material	The manufacturer states that its implants are made from commercially pure grade IV titanium to ASTM F67Manufacturer-reported[1]
Surface	SInergy, the manufacturer’s own surface treatmentManufacturer-reported[1]
Manufacturer-described indication	Range includes external hex, internal hex, deep conical and tapered bodies, plus site-specific zygomatic, pterygoid, anterior and molar designsManufacturer-reported[1]
manufacturingCountry	South AfricaVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Southern Implants occupies a niche the large groups have largely left alone: implants shaped for specific anatomical sites, including zygomatic implants anchored in the cheekbone for severely resorbed upper jaws. It is one of very few independent manufacturers of any scale left, still privately owned from Irene in South Africa since 1987. The implants are made from commercially pure grade IV titanium rather than an alloy, which the company states explicitly. Because the brand is chosen by surgeons for difficult cases rather than requested by patients, its main practical implication is that follow-up care usually needs to return to a clinician familiar with the system.

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]Profile — Southern Implants — Southern Implants (Pty) Ltd. Accessed 2026-07-21.
[2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.