510(k) Report

510(k) · Cleared

Recalled · 2007

Dorsal Columella Implant

K944166510(k) TraditionalCleared Nov 4, 199470-day reviewClass II21 CFR 878.3550Recalls 1

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

Spectrum Designs, Inc. · LZK Implant, Malar

Cleared on Nov 4, 1994 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. It has been recalled once.

Decided
Nov 4, 1994
Review
70 days
Class
Class II
Product code
LZK
Recalls
1
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K944166Source: FDA 510(k) database · 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.

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  • 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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 24, 2007Not classifiedZ-1264-2007OtherMispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal implant.

No ancestor or descendant has a Class I recall.

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 Spectrum Designs, Inc.

18 FDA decisions under this applicant name. See the company

  • K992522Spectrum Designs SpectragelSpectrum Designs, Inc. · 1999
  • K982688Spectrum Designs Pre-Form Contour Silicone Carving BlockSpectrum Designs, Inc. · 1998
  • K980444Spectrum Designs Bilateral Groove Chin ImplantSpectrum Designs, Inc. · 1998
  • K980462Spectrum Designs Anatomical Chin ImplantSpectrum Designs, Inc. · 1998
  • K980463Spectrum Designs Curvilinear Chin ImplantSpectrum Designs, Inc. · 1998

Recent decisions in LZK

The LZK category page

  • K021419Aart Malar ImplantAesthetic and Reconstructive Technologies, Inc. · 20021 recall
  • K002886Implantech Composite Facial Implants (Malar, Chin, and Nasal)Implantech Associates, Inc. · 2000
  • K992240Pillar Malar ImplantPillar Surgical, Inc. · 1999
  • K983756Surgiform Anatomical MalarSurgical Technology Laboratories, Inc. · 1998
  • K982763Seare Biomedical Malar ImplantsSeare Biomedical Corp. · 1998

https://510kreport.com/device/K944166 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944166: Dorsal Columella Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944166

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026