510(k) · Cleared
ClearedMedicon Epiplating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cmf Medicon Surgical, Inc. · FZE Prosthesis, Nose, Internal
Cleared on Dec 12, 2024 as substantially equivalent to K161548 (Southern Implants (Pty), Ltd., 2016) after a 223-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Dec 12, 2024
- Review
- 223 days
- Class
- Class II
- Product code
- FZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945154 (1995). 17 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK945154 BA-CpasNobelpharma USA, Inc. · 1995
- 2 generations backK990458 Straumann Extraoral Implant SystemStraumann USA · 1999
- 1 generation backK161548 Osseointegrated FixturesSouthern Implants (Pty), Ltd. · 2016
- This deviceK241253 Medicon Epiplating SystemCmf Medicon Surgical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945154 | BA-Cpas | Nobelpharma USA, Inc. | 1995 | — |
| −2 | K990458 | Straumann Extraoral Implant System | Straumann USA | 1999 | — |
| −1 | K161548 | Osseointegrated Fixtures | Southern Implants (Pty), Ltd. | 2016 | — |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K161548 | Osseointegrated FixturesSummary page 5…cate Device Manufacturer Device Name K Number Classification Southern Implants Osseointegrated Fixtures K161548 Prosthesis, Nose, (Pty) Ltd. Internal Reference Devic… | 2016 |
| † | K951690 | Titanium Miniplate System | 1995 |
| † | K951691 | CMS Cranio Maxillo Facial Titanium Implant System | 1995 |
| † | K961719 | Epitec Titanium Implant System for the Surgical Anchoring of Facial Prostheses | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- None of the 17 ancestors has a recall.
How does its category compare?
All FZE devicesFZE Prosthesis, Nose, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The Medicon Epiplating System is indicated for the attachment of an external restoration prosthesis for restoration of a physical defect when other means of attachment are inadequate. The Epiplating system 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/K241253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241253: Medicon Epiplating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241253
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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