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 Dec 23, 2020 as substantially equivalent to K191130 (Implantech Associates, Inc., 2019) and 3 other predicates after a 289-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Dec 23, 2020
- Review
- 289 days
- Class
- Class II
- Product code
- FWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K913761 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913761 | 3-D Accuscan Facial Implants | Implantech Associates, Inc. | 1991 | — |
| −1 | K191130 | Customized Contour Implant | Implantech Associates, Inc. | 2019 | — |
| 0 (this device) | K200610 | Customized Contour Implant | Implantech Associates, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2005 | 2 | 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
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K191130 | Customized Contour ImplantSummary page 5…d Contour Implant is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K191130 Customized Contour Implant/Implantech Associates, Inc. Gluteal Implant, Models RND 5-X,… | 2019 |
| * | K052504 | Gluteal Implant, Models RND 5-X, TRD 6-XSummary page 5…ary Predicate K191130 Customized Contour Implant/Implantech Associates, Inc. Gluteal Implant, Models RND 5-X, TRD 6-X/Implantech K052504 Associates, Inc. K052505 Calf Implant, Model EC17-X/Implantech Associates, Inc. K952708 Pector… | 2005 |
| * | K052505 | Calf Implant, Model EC17-XSummary page 5…Contour Implant/Implantech Associates, Inc. Gluteal Implant, Models RND 5-X, TRD 6-X/Implantech K052504 Associates, Inc. K052505 Calf Implant, Model EC17-X/Implantech Associates, Inc. K952708 Pectoralis Implant/Spirit Ridge Technologies The… | 2005 |
| * | K952708 | Pectoralis ImplantSummary page 5…Gluteal Implant, Models RND 5-X, TRD 6-X/Implantech K052504 Associates, Inc. K052505 Calf Implant, Model EC17-X/Implantech Associates, Inc. K952708 Pectoralis Implant/Spirit Ridge Technologies The predicate devices have not been subject to a design related recall. DE… | 1995 |
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 1 company; a new generation was cleared every 27.8 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K191130.
How does its category compare?
All FWP devicesFWP Prosthesis, Chin, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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. The Customized Contour Implant is pre-shaped to the surgeon’s specification to meet the needs of a particular patient, for example facial implants, gluteal implants, calf implants, or pectoralis implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200610: 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/K200610
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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