510(k) · Cleared
ClearedePTFE-Coated Auricular Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implantech Associates, Inc. · FZD Prosthesis, Ear, Internal
Cleared on Jul 18, 2018 as substantially equivalent to K863939 (Porex Medical, 1986) and 2 other predicates after a 344-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jul 18, 2018
- Review
- 344 days
- Class
- Class II
- Product code
- FZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K863939 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK863939 Porex (TM) Ear ProsthesisPorex Medical · 1986
- This deviceK172389 ePTFE-Coated Auricular ImplantImplantech Associates, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863939 | Porex (TM) Ear Prosthesis | Porex Medical | 1986 | — |
| 0 (this device) | K172389 | ePTFE-Coated Auricular Implant | Implantech Associates, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2014 | 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 FZD? 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? (3)
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 |
|---|---|---|---|
| * | K863939 | Porex (TM) Ear ProsthesisSummary page 5…icular Implant is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K863939 Porex Ear Prosthesis / Porex Medical Implantech ePTFE Facial Implants / Implantech K141027… | 1986 |
| * | K141027 | 3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar…Summary page 5…cturer Primary Predicate K863939 Porex Ear Prosthesis / Porex Medical Implantech ePTFE Facial Implants / Implantech K141027 Associates Implantech Composite Facial Implants / Implantech K002886 Associates SUMMARY… | 2014 |
| * | K002886 | Implantech Composite Facial Implants (Malar, Chin, and Nasal)Summary page 5…ical Implantech ePTFE Facial Implants / Implantech K141027 Associates Implantech Composite Facial Implants / Implantech K002886 Associates SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have been established for the ePTFE-Coated A… | 2000 |
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All FZD devicesFZD Prosthesis, Ear, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FZD
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · FZD
Too few FZD 510(k)s in any year since 2007 to give a median.
Recalls per year · FZD
No recall names FZD since 2007.
Adverse event reports per year · FZD
1in 2023
MAUDE reports naming product code FZD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ePTFE-Coated Auricular Implant is intended for reconstruction of the external ear.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172389: ePTFE-Coated Auricular Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172389
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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