510(k) · Cleared
ClearedOsseointegrated Fixtures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southern Implants (Pty), Ltd. · FZE Prosthesis, Nose, Internal
Cleared on Dec 1, 2016 as substantially equivalent to K020617 (Nsi, 2002) and 3 other predicates after a 181-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Dec 1, 2016
- Review
- 181 days
- Class
- Class II
- Product code
- FZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K945154 (1995). 16 ancestors in all, the oldest K874590 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK945154 BA-CpasNobelpharma USA, Inc. · 1995
- 1 generation backK990458 Straumann Extraoral Implant SystemStraumann USA · 1999
- This deviceK161548 Osseointegrated FixturesSouthern Implants (Pty), Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK241253 Medicon Epiplating SystemCmf Medicon Surgical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945154 | BA-Cpas | Nobelpharma USA, Inc. | 1995 | — |
| −1 | K990458 | Straumann Extraoral Implant System | Straumann USA | 1999 | — |
| 0 (this device) | K161548 | Osseointegrated Fixtures | Southern Implants (Pty), Ltd. | 2016 | — |
| +1 | K241253 | Medicon Epiplating System | Cmf Medicon Surgical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FZE device
- #1 K241253 Medicon Epiplating Systemscore 9.1 · 3 generations · no Class I recall
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020617 | Nsi Hexed and Non-Hexed Implant SystemSummary page 4…e devices) Manufacturer Device Name K Number NSI, Inc. NSI Hexed and Non-Hexed Implant System K020617 (Manufactured by Southern Implants) NSI, Inc. NSI Hexed and Non-Hexed Implant System K003620 (Manufacture… | 2002 |
| * | K003620 | Nsi Hexed and Non-Hexed Implant SystemSummary page 4…NSI Hexed and Non-Hexed Implant System K020617 (Manufactured by Southern Implants) NSI, Inc. NSI Hexed and Non-Hexed Implant System K003620 (Manufactured by Southern Implants) Nobel Biocare Nobel Biocare Endosseous Implants K090630… | 2001 |
| * | K090630 | Nobel Biocare Endosseous Implants (Maxillofacial Indication)Summary page 4…NSI Hexed and Non-Hexed Implant System K003620 (Manufactured by Southern Implants) Nobel Biocare Nobel Biocare Endosseous Implants K090630 (Maxillofacial Indications) Straumann USA Straumann Extraoral Implant Sys… | 2009 |
| * | K990458 | Straumann Extraoral Implant SystemSummary page 4…s Implants K090630 (Maxillofacial Indications) Straumann USA Straumann Extraoral Implant System K990458 Device Description The device ‘Osseointegrated Fixtures’ refers to a system involving endosseous implants and their accessories.… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241253 | Medicon Epiplating System | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 17.6 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K241253 (Cmf Medicon Surgical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K020617.
How does its category compare?
All FZE devicesFZE Prosthesis, Nose, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FZE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FZE
Too few FZE 510(k)s in any year since 2007 to give a median.
Recalls per year · FZE
No recall names FZE since 2007.
Adverse event reports per year · FZE
13in 2025
MAUDE reports naming product code FZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 24 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 0 | — | 0 | 30 |
| 2023 | 0 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 26 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161548: Osseointegrated Fixtures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161548
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026