510(k) Report

510(k) · Cleared

Cleared

Chin (Mentoplasty) Implants

K831724510(k) TraditionalCleared Aug 12, 198373-day reviewClass II21 CFR 878.3550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

S. Jackson, Inc. · FWP Prosthesis, Chin, Internal

Cleared on Aug 12, 1983 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Aug 12, 1983
Review
73 days
Class
Class II
Product code
FWP
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared19801990200020102020
  1. This deviceK831724 Chin (Mentoplasty) ImplantsS. Jackson, Inc. · 1983
  2. Descendant · cites it directly · 2 of its ownK080216 Supramesh ExtraS. Jackson, Inc. · 2008
  3. Descendant · 2 generations on · 1 of its ownK083102 Refine Lift SystemAlure Medical, Inc. · 2009
  4. Descendant · 3 generations on · 0 of its ownK092538 Refine Support System, Model 100.0100Alure Medical, Inc. · 2010

Most influential descendants

Showing 3 of 3 · See all
  • K080216Supramesh ExtraS. Jackson, Inc. · 2008 · cites it directly2descendants
  • K083102Refine Lift SystemAlure Medical, Inc. · 2009 · 2 generations on1descendant
  • K092538Refine Support System, Model 100.0100Alure Medical, Inc. · 2010 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K831724Chin (Mentoplasty) ImplantsS. Jackson, Inc.1983—
+1K080216Supramesh ExtraS. Jackson, Inc.2008—
+2K083102Refine Lift SystemAlure Medical, Inc.2009—
+3K092538Refine Support System, Model 100.0100Alure Medical, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
FIG. 1 — Lineage of K831724, 1983–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K254233 MEDPOR Customized Implant Kitscore 13.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, 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.

NumberDeviceApplicantDecidedDescendants
K080216Supramesh ExtraS. Jackson, Inc.20082

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, K080216 (S. Jackson, Inc., 2008) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FWP devices

FWP Prosthesis, Chin, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FWP

1in 2023

2009: 12012: 12014: 12015: 12016: 22019: 22020: 12023: 12026 (partial year): 1
2007high 2 (2016) · low 0 (2007)2026

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

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FWP

17in 2025

2007: 32008: 32009: 52010: 12011: 222012: 62013: 92014: 52015: 82016: 62017: 132018: 72019: 152020: 62021: 132022: 122023: 62024: 102025: 17
2007high 22 (2011) · low 1 (2010)2025

MAUDE reports naming product code FWP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—03
20091—05
20100—01
20110—022
20121—06
20130—09
20141—05
20151—08
20162—06
20170—013
20180—07
20192—015
20201—06
20210—013
20220—012
20231—06
20240—010
20250—117
20261—0—

More from S. Jackson, Inc.

30 FDA decisions under this applicant name. See the company

  • K080216Supramesh ExtraS. Jackson, Inc. · 2008
  • K973379Sterile Suprafoil Smooth Nylon Foil SheetsS. Jackson, Inc. · 1997
  • K931613Supramid SutureS. Jackson, Inc. · 1993
  • K931612Nylamid SutureS. Jackson, Inc. · 1993
  • K931614Mopylen SutureS. Jackson, Inc. · 1993

Recent decisions in FWP

The FWP category page

  • K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG · 2026
  • K232593FITme Customized Silicone ImplantKeosan Trading Co. · 2023
  • K200610Customized Contour ImplantImplantech Associates, Inc. · 2020
  • K191130Customized Contour ImplantImplantech Associates, Inc. · 2019
  • K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KG · 2019

https://510kreport.com/device/K831724 · printed Nov 3, 2026

Cite this page

510(k) Report. “K831724: Chin (Mentoplasty) Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K831724

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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