# K161548: Osseointegrated Fixtures

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Dec 1, 2016 after 181 days
- Product code: FZE (Prosthesis, Nose, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945154 (1995). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020617: Nsi Hexed and Non-Hexed Implant System, Nsi (2002) Summary page 4.
- K003620: Nsi Hexed and Non-Hexed Implant System, Nsi (2001) Summary page 4.
- K090630: Nobel Biocare Endosseous Implants (Maxillofacial Indication), Nobel Biocare AB (2009) Summary page 4.
- K990458: Straumann Extraoral Implant System, Straumann USA (1999) Summary page 4.

## Most influential descendants
- K241253: Medicon Epiplating System (2024), 0 descendants of its own

## Indications for use
Southern Implants Osseointegrated Fixtures are indicated for the attachment of an external aesthetic restoration prosthesis for the restoration of a physical defect when other means of attachment are inadequate. The endosseous implant provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye).

Source page: https://510kreport.com/device/K161548
Methodology: https://510kreport.com/methodology