510(k) · Cleared
ClearedCustomized Contour Implant
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 Aug 23, 2019 as substantially equivalent to K913761 (Implantech Associates, Inc., 1991) after a 116-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Aug 23, 2019
- Review
- 116 days
- Class
- Class II
- Product code
- FWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913761 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK913761 3-D Accuscan Facial ImplantsImplantech Associates, Inc. · 1991
- This deviceK191130 Customized Contour ImplantImplantech Associates, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK232593 FITme Customized Silicone ImplantKeosan Trading Co. · 2023
- Descendant · cites it directly · 0 of its ownK200610 Customized Contour ImplantImplantech Associates, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913761 | 3-D Accuscan Facial Implants | Implantech Associates, Inc. | 1991 | — |
| 0 (this device) | K191130 | Customized Contour Implant | Implantech Associates, Inc. | 2019 | — |
| +1 | K232593 | FITme Customized Silicone Implant | Keosan Trading Co. | 2023 | — |
| +1 | K200610 | Customized Contour Implant | Implantech Associates, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K913761 | 3-D Accuscan Facial ImplantsSummary page 4…Contour Implant is substantially equivalent to the following predicate: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K913761 3‐D Accuscan Facial Implants / Implantech Associates The predicate device has not been subject to a des… | 1991 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K232593 (Keosan Trading Co., 2023) 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. 2019, this device’s year, is highlighted.
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?
The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions.
The Customized Contour Implant is pre-shaped to the surgeon’s specification to meet the needs of a particular patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191130: Customized Contour Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191130
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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