510(k) Report

510(k) · Cleared

Cleared

Mimix Bone Replacement System

K003494510(k) TraditionalCleared Apr 9, 2001147-day reviewClass II21 CFR 872.3930

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

Biomet, Inc. · LYC Bone Grafting Material, Synthetic

Cleared on Apr 9, 2001 after a 147-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Apr 9, 2001
Review
147 days
Class
Class II
Product code
LYC
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared200020052010201520202025
  1. This deviceK003494 Mimix Bone Replacement SystemBiomet, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK041089 Oss Bone Graft System and Oss Rapidset Bone Graft SystemBiomet Manufacturing, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K041089Oss Bone Graft System and Oss Rapidset Bone Graft SystemBiomet Manufacturing, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003494Mimix Bone Replacement SystemBiomet, Inc.2001—
+1K041089Oss Bone Graft System and Oss Rapidset Bone Graft SystemBiomet Manufacturing, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K003494, 2001–2004Source: 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 LYC? 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 LYC device

  1. #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041089Oss Bone Graft System and Oss Rapidset Bone Graft SystemBiomet Manufacturing, Inc.20040

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, K041089 (Biomet Manufacturing, Inc., 2004) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LYC devices

LYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYC

3in 2025

2007: 132008: 82009: 142010: 132011: 92012: 52013: 22014: 12016: 22020: 32022: 22025: 32026 (partial year): 3
2007high 14 (2009) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYC

267in 2025

2007: 80 days median2008: 73 days median2009: 100 days median2010: 164 days median2011: 224 days median2012: 120 days median2020: 156 days median2025: 267 days median2026 (partial year): 266 days median
2007high 267 (2025) · low 73 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYC

1in 2018

2009: 12010: 22012: 22016: 22018: 1
2007high 2 (2010) · low 0 (2007)2026

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

Adverse event reports per year · LYC

2in 2025

2007: 232008: 252009: 252010: 282011: 212012: 102013: 122014: 92015: 142016: 1402017: 192018: 142019: 152020: 52021: 122022: 62023: 92024: 62025: 2
2007high 140 (2016) · low 2 (2025)2025

MAUDE reports naming product code LYC, 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
20071380023
2008873025
200914100125
201013164228
20119224021
20125120210
20132—012
20141—09
20150—014
20162—2140
20170—019
20180—114
20190—015
2020315605
20210—012
20222—06
20230—09
20240—06
2025326702
202632660—

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in LYC

The LYC category page

  • K253317Cytrans™ ElashieldGC America, Inc. · 2026
  • K253883Bonalive MaxillofacialBonalive, Ltd. · 2026
  • K251818Bontree PlusHudens Bio Co., Ltd. · 2026
  • K244006FG Bone Graft MFull Golden Biotech Co., Ltd. · 2025
  • K243745FG Bone Graft BFull Golden Biotech Corporation · 2025

https://510kreport.com/device/K003494 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003494: Mimix Bone Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003494

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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