510(k) · Cleared
Cleared3-D Accuscan Facial Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implantech Associates, Inc. · FWP Prosthesis, Chin, Internal
Cleared on Oct 17, 1991 after a 57-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Oct 17, 1991
- Review
- 57 days
- Class
- Class II
- Product code
- FWP
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK913761 3-D Accuscan Facial ImplantsImplantech Associates, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK191130 Customized Contour ImplantImplantech Associates, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK232593 FITme Customized Silicone ImplantKeosan Trading Co. · 2023
- Descendant · 2 generations on · 0 of its ownK200610 Customized Contour ImplantImplantech Associates, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913761 | 3-D Accuscan Facial Implants | Implantech Associates, Inc. | 1991 | — |
| +1 | K191130 | Customized Contour Implant | Implantech Associates, Inc. | 2019 | — |
| +2 | K232593 | FITme Customized Silicone Implant | Keosan Trading Co. | 2023 | — |
| +2 | K200610 | Customized Contour Implant | Implantech Associates, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191130 | Customized Contour Implant | 2019 | 2 |
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?
- Of its descendants, K191130 (Implantech Associates, Inc., 2019) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K913761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913761: 3-D Accuscan Facial Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913761
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026