Southern Implants Co-Axis
Also known as: Co-Axis, Subcrestal Angle Correction
An implant design from Southern Implants in which the prosthetic platform and screw channel are built at an angle to the long axis of the implant, correcting angulation within the implant itself.
Quick facts
| Manufacturer | Southern Implants (Pty) LtdManufacturer-reported[1][2] |
|---|---|
| Implant level | Insufficient evidence(Southern's Co-Axis product page and the External Hex and Deep Conical Instructions for Use were read in full; neither classifies the implant as bone level or tissue level. The product page says only that the design “allows the placement of the implant platform at crestal level”, and the surgical sequences describe placing the mesial corner of the drill at bone level with the distal corner subcrestal. No bone-level or tissue-level designation is therefore recorded.) |
| Body geometry | Prosthetic platform and screw hole tilted at 12, 24 or 36 degrees to the long axis of the implant, a feature Southern calls Subcrestal Angle CorrectionManufacturer-reported[1] |
| Material | Commercially pure titanium, grade 4, to ASTM F67 and ISO 5832-2, with an ultimate tensile strength of at least 900 MPa. Southern describes it as “commercially pure special Grade 4 Titanium”.Manufacturer-reported[3][4]Taken from the Instructions for Use for the two ranges whose IFUs name Co-Axis explicitly (External Hex and Deep Conical). Both state the same grade. Southern's Co-Axis product page uses only the looser phrase “High Strength Titanium”, so the IFU wording is used here. |
| Surface | Alumina-blasted, moderately rough surface (Southern's SInergy surface), roughened up to the collar, with a stated Sa of 1.4 µm. MSC (Machined Surface Coronally) variants are also offered in the External Hex and Provata ranges, in which the coronal 3 mm of the implant is left machined.Manufacturer-reported[3][4][5][6] |
| Connection | Available across several of Southern’s internal configurationsManufacturer-reported[1]The specific connection depends on which Co-Axis variant is ordered; we have not resolved the full mapping. |
| Available diameters | ∅ 3.25 to 6.00 mm overall, varying by host range: External Hex ∅ 3.25, 4.0, 5.0 and 6.0 mm (∅ 4.0 and ∅ 5.0 also as reduced-platform versions); TRI-NEX ∅ 4.3 and 5.0 mm (reduced platform); Internal Hex (M-series) ∅ 4.2 mm; IT internal octagon ∅ 4.0 and 5.0 mm; Deep Conical ∅ 3.5, 4.0 and 5.0 mm; Provata ∅ 3.3, 4.0 and 5.0 mm.Manufacturer-reported[6][7][8][9][10][11][5]Co-Axis is a platform modification applied across several Southern ranges rather than a single implant line, so the diameters have been taken from each range's own ordering catalogue. The ∅ 3.25–6.00 mm envelope matches the range Southern quotes on the Co-Axis product page. Angulation is not offered on every diameter: 24° and 36° appear only in the External Hex reduced-platform lines and, for 24°, the ∅ 6.0 mm External Hex implant. Southern states that not all products are cleared for sale in all countries. |
| Available lengths | 8.0 to 24.0 mm overall, varying by host range and angulation. External Hex 12°: 8.5, 10, 11.5, 13, 15 and 18 mm (∅ 5.0 mm standard-platform and ∅ 6.0 mm start at 10 mm); External Hex 24° and 36° reduced-platform: the same plus 20, 22 and 24 mm. TRI-NEX 12°: 10.5, 12.0, 13.5 and 16.5 mm. Internal Hex ∅ 4.2 mm 12°: 8, 10, 11.5, 13, 15 and 18 mm. IT ∅ 4.0 and 5.0 mm 12°: 8, 10, 12 and 14 mm. Deep Conical 12°: 8, 9, 11, 13 and 15 mm. Provata 12°: 8.5, 10, 11.5, 13, 15 and 18 mm.Manufacturer-reported[6][7][8][9][10][11]Lengths are the L1 (implant) dimension from each catalogue's Co-Axis ordering table, not the L2 overall dimension, which is longer because the platform is angled. TRI-NEX item codes are numbered differently from their L1 length (code IA43-12d-10 is a 10.5 mm implant), so the L1 figures are given here. Southern's Co-Axis product page summarises the range as 8.5–18 mm, which does not cover the 8 mm and 9 mm short options or the 20–24 mm reduced-platform options that appear in the ordering catalogues; the catalogues are treated as authoritative. Not all products are cleared for sale in all countries. |
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 Co-Axis. 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 Co-Axis 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.
- [3]Instructions for Use: Southern Implants® External Hex Implants (CAT-8064-02) — Southern Implants (Pty) Ltd, 2022. Accessed 2026-07-22.
- [4]Instructions for Use: Southern Implants® Deep Conical Implants (CAT-8059-01) — Southern Implants (Pty) Ltd, 2021. Accessed 2026-07-22.
- [5]Co-Axis® Implants — Subcrestal Angle Correction — Southern Implants (Pty) Ltd. Accessed 2026-07-22.
- [6]External Hex Implants Product Catalogue (CAT-2020-12) — Southern Implants (Pty) Ltd. Accessed 2026-07-22.
- [7]TRI-NEX Implants Product Catalogue (CAT-2004-14) — Southern Implants (Pty) Ltd. Accessed 2026-07-22.
- [8]Internal Hex Implants Product Catalogue (CAT-2043-05) — Southern Implants (Pty) Ltd. Accessed 2026-07-22.
- [9]IT (Internal Octagon) Implants Product Catalogue (CAT-2005-15) — Southern Implants (Pty) Ltd. Accessed 2026-07-22.
- [10]Deep Conical Implants Product Catalogue (CAT-2042-13) — Southern Implants (Pty) Ltd. Accessed 2026-07-22.
- [11]PROVATA Implants Product Catalogue (CAT-2060-05) — Southern Implants (Pty) Ltd. Accessed 2026-07-22.