510(k) Report

510(k) · Cleared

Cleared

Silmax Pectoral Implant

K002633510(k) TraditionalCleared Nov 21, 200090-day reviewClass II21 CFR 874.3620

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

Pillar Surgical, Inc. · MIC Implant, Muscle, Pectoralis

Cleared on Nov 21, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 21, 2000
Review
90 days
Class
Class II
Product code
MIC
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K002633Source: 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.

Planning a device in MIC? 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 has not posted a summary or statement for it, 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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MIC devices

MIC Implant, Muscle, Pectoralis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MIC

FDA has decided no MIC device since 2007.

Median 510(k) review, days · MIC

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

Recalls per year · MIC

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 · MIC

2in 2024

2010: 12012: 22017: 22019: 22020: 12021: 12022: 12023: 12024: 2
2007high 2 (2012) · low 0 (2007)2025

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

More from Pillar Surgical, Inc.

5 FDA decisions under this applicant name. See the company

  • K002629Silmax Contour Carving Block ImplantPillar Surgical, Inc. · 2000
  • K992239Pillar Chin ImplantPillar Surgical, Inc. · 1999
  • K992242Pillar Nasal, Dorsal Columella and Nasal Dorsum ImplantsPillar Surgical, Inc. · 1999
  • K992240Pillar Malar ImplantPillar Surgical, Inc. · 1999

Recent decisions in MIC

The MIC category page

  • K021337Aart Pectoralis ImplantAesthetic and Reconstructive Technologies, Inc. · 20021 recall
  • K982762Seare Biomedical Pectoralis ImplantSeare Biomedical Corp. · 1998
  • K983043Seare Biomedical Silicone BlockSeare Biomedical Corp. · 1998
  • K973729Powerflex Pec ImplantHanson Medical, Inc. · 1997
  • K961072Pec ImplantRand Scientific Corp. · 1996

https://510kreport.com/device/K002633 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002633: Silmax Pectoral Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002633

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