510(k) Report

510(k) · Cleared

Cleared

Implantech Composite Facial Implants (Malar, Chin, and Nasal)

K002886510(k) TraditionalCleared Nov 24, 200070-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

Implantech Associates, Inc. · LZK Implant, Malar

Cleared on Nov 24, 2000 after a 70-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
Nov 24, 2000
Review
70 days
Class
Class II
Product code
LZK
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2009: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK002886 Implantech Composite Facial Implants (Malar, Chin, and Nasal)Implantech Associates, Inc. · 2000
  2. Descendant · cites it directly · 1 of its ownK091011 Pureform Eptfe Facial Implants (Nasal, Chin, Maler)Surgical Technology Laboratories, Inc ("Stl") · 2009
  3. Descendant · 2 generations on · 0 of its ownK201153 Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd. · 2023
  4. Descendant · cites it directly · 0 of its ownK172389 ePTFE-Coated Auricular ImplantImplantech Associates, Inc. · 2018

Most influential descendants

Showing 3 of 3 · See all
  • K091011Pureform Eptfe Facial Implants (Nasal, Chin, Maler)Surgical Technology Laboratories, Inc ("Stl") · 2009 · cites it directly1descendant
  • K201153Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd. · 2023 · 2 generations on0descendants
  • K172389ePTFE-Coated Auricular ImplantImplantech Associates, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002886Implantech Composite Facial Implants (Malar, Chin, and Nasal)Implantech Associates, Inc.2000—
+1K091011Pureform Eptfe Facial Implants (Nasal, Chin, Maler)Surgical Technology Laboratories, Inc ("Stl")2009—
+2K201153Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd.2023—
+1K172389ePTFE-Coated Auricular ImplantImplantech Associates, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201810
202310
FIG. 1 — Lineage of K002886, 2000–2023Source: 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 LZK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091011Pureform Eptfe Facial Implants (Nasal, Chin, Maler)Surgical Technology Laboratories, Inc ("Stl")20091
K172389ePTFE-Coated Auricular ImplantImplantech Associates, Inc.20180

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, K091011 (Surgical Technology Laboratories, Inc ("Stl"), 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LZK devices

LZK Implant, Malar: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZK

FDA has decided no LZK device since 2007.

Median 510(k) review, days · LZK

Too few LZK 510(k)s in any year since 2007 to give a median.

Recalls per year · LZK

1in 2025

2007: 32025: 1
2007high 3 (2007) · low 0 (2008)2026

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

Adverse event reports per year · LZK

1in 2022

2007: 102008: 52009: 22010: 42011: 42012: 72013: 12014: 12015: 32016: 12017: 32018: 22019: 22020: 12021: 12022: 1
2007high 10 (2007) · low 0 (2023)2025

MAUDE reports naming product code LZK, 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—310
20080—05
20090—02
20100—04
20110—04
20120—07
20130—01
20140—01
20150—03
20160—01
20170—03
20180—02
20190—02
20200—01
20210—01
20220—01
20230—00
20240—00
20250—10
20260—0—

More from Implantech Associates, Inc.

41 FDA decisions under this applicant name. See the company

  • K200610Customized Contour ImplantImplantech Associates, Inc. · 2020
  • K191130Customized Contour ImplantImplantech Associates, Inc. · 2019
  • K172389ePTFE-Coated Auricular ImplantImplantech Associates, Inc. · 2018
  • K1410273D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar II Implant, Dorsal…Implantech Associates, Inc. · 2014
  • K071470Implantech Eptfe Sheeting, Model Eptfe-XXXImplantech Associates, Inc. · 2007

Recent decisions in LZK

The LZK category page

  • K021419Aart Malar ImplantAesthetic and Reconstructive Technologies, Inc. · 20021 recall
  • K992240Pillar Malar ImplantPillar Surgical, Inc. · 1999
  • K983756Surgiform Anatomical MalarSurgical Technology Laboratories, Inc. · 1998
  • K982763Seare Biomedical Malar ImplantsSeare Biomedical Corp. · 1998
  • K981835Silimed Malar ImplantSilimed, LLC · 1998

https://510kreport.com/device/K002886 · printed Nov 4, 2026

Cite this page

510(k) Report. “K002886: Implantech Composite Facial Implants (Malar, Chin, and Nasal).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002886

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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