510(k) · Cleared
ClearedDuralastic Anatomical Chin Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hanson Medical, Inc. · FWP Prosthesis, Chin, Internal
Cleared on Nov 7, 1997 as substantially equivalent to K971478 (Allied Biomedical Corp., 1997) after a 49-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Nov 7, 1997
- Review
- 49 days
- Class
- Class II
- Product code
- FWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971478 (1997). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K090803Hanson Medical Facial ImplantsHanson Medical, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971478 | Duralastic Anatomical Chin Implants | Allied Biomedical Corp. | 1997 | — |
| 0 (this device) | K973575 | Duralastic Anatomical Chin Implants | Hanson Medical, Inc. | 1997 | — |
| +1 | K090803 | Hanson Medical Facial Implants | Hanson Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 FWP? 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 FWP device
- #1 K254233 MEDPOR Customized Implant Kitscore 13.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K971478 | Duralastic Anatomical Chin ImplantsSummary page 1…2. The Duralastic Chin Implants will be provided sterile and nonsterile. SUBSTANTIAL EQUIVALENCE Duralastic Chin implants are SE to the Allied Biomedical chin implants K971478. They are soft solid silicone implant grade cresent shaped implants in various sizes and styles. INTENDED USE Duralastic Chin i… | 1997 |
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 |
|---|---|---|---|
| K090803 | Hanson Medical Facial Implants | 2010 | 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?
- Its one ancestor has no recall.
- Of its descendants, K090803 (Hanson Medical, Inc., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FWP devicesFWP Prosthesis, Chin, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FWP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FWP
Too few FWP 510(k)s in any year since 2007 to give a median.
Recalls per year · FWP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FWP
17in 2025
MAUDE reports naming product code FWP, 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 | 3 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 22 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 1 | 17 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
To augment or reconstruct the chin or anterior mandibular contour.
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/K973575 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973575: Duralastic Anatomical Chin Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973575
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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