510(k) Report

510(k) · Cleared

Cleared

Cementek

K041493510(k) TraditionalCleared Aug 19, 200476-day reviewClass II21 CFR 888.3045

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

Teknimed, S.A. · MQV Filler, Bone Void, Calcium Compound

Cleared on Aug 19, 2004 as substantially equivalent to K022622 (Berkeley Advanced Biomaterials, Inc., 2003) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 2001.

Decided
Aug 19, 2004
Review
76 days
Class
Class II
Product code
MQV
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K011048 (2001). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestorK011048 · BSM Bone Substitute Material · DePuy Orthopaedics, Inc. · 20012000200220042006
Other ancestors, by generation 1 generation back: 1 other ancestor K011048 · BSM Bone Substitute Material · DePuy Orthopaedics, Inc. · 20010
  1. Root · 1 generation backK011048 BSM Bone Substitute MaterialDePuy Orthopaedics, Inc. · 2001
  2. This deviceK041493 CementekTeknimed, S.A. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011048BSM Bone Substitute MaterialDePuy Orthopaedics, Inc.2001—
0 (this device)K041493CementekTeknimed, S.A.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K041493, 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MQV? 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 MQV device

  1. #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 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? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K022622Cem-Ostetic, Models Cemo-020O, Cemo-05P, Cemo-10P, Cemo-20P, and Cemo-30P
Summary page 1
…ne void filler Classification name: Class IIper 21 CFR section 888.3045 Product Code: MQV Equivalent Device: Cem-OsteticTM (Berkley Advanced Biomaterials - K022622) a-BSM (DePuy - K01 1048). Device Description As a malleable bone substitute, Cementek® is packaged as a s…
Berkeley Advanced Biomaterials, Inc.2003—
*K011048BSM Bone Substitute Material
Summary page 1
…er 21 CFR section 888.3045 Product Code: MQV Equivalent Device: Cem-OsteticTM (Berkley Advanced Biomaterials - K022622) a-BSM (DePuy - K01 1048). Device Description As a malleable bone substitute, Cementek® is packaged as a solid phase and a liquid phase. The liquid and s…
DePuy Orthopaedics, Inc.2001—

Also cleared against K022622: 2 other devices →

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.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • 2 other devices also cite its predicate K022622.

How does its category compare?

All MQV devices

MQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQV

14in 2025

2007: 352008: 322009: 232010: 172011: 162012: 92013: 122014: 202015: 182016: 82017: 172018: 232019: 132020: 152021: 82022: 92023: 212024: 282025: 142026 (partial year): 5
2007high 35 (2007) · low 8 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQV

57in 2025

2007: 144 days median2008: 102 days median2009: 180 days median2010: 147 days median2011: 92 days median2012: 107 days median2013: 197 days median2014: 153 days median2015: 184 days median2016: 214 days median2017: 124 days median2018: 124 days median2019: 90 days median2020: 132 days median2021: 88 days median2022: 118 days median2023: 74 days median2024: 55 days median2025: 57 days median2026 (partial year): 96 days median
2007high 214 (2016) · low 55 (2024)2026

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

Recalls per year · MQV

1in 2025

2007: 52008: 32009: 12011: 62012: 32013: 22016: 12017: 12018: 22020: 12023: 32024: 22025: 12026 (partial year): 4
2007high 6 (2011) · low 0 (2010)2026

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

Adverse event reports per year · MQV

57in 2025

2007: 672008: 712009: 812010: 682011: 1142012: 1492013: 2232014: 1112015: 1252016: 1062017: 1072018: 862019: 652020: 1262021: 1012022: 472023: 1202024: 682025: 57
2007high 223 (2013) · low 47 (2022)2025

MAUDE reports naming product code MQV, 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
200735144567
200832102371
200923180181
201017147068
201116926114
201291073149
2013121972223
2014201530111
2015181840125
201682141106
2017171241107
201823124286
20191390065
2020151321126
20218880101
20229118047
202321743120
20242855268
20251457157
20265964—

What is it indicated for?

Cementek® is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be molded to specific shapes and placed into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, Cementek® resorbs and is replaced with bone during the healing process.

Indications for use as stated in the FDA summary.

Also cleared against K022622

2 other devices cite the same predicate.

  • K051951Cerament Bone Void FillerBonesupport AB · 2005
  • K040600Genex Bone Graft SubstituteBiocomposites, Ltd. · 2004

More from Teknimed, S.A.

11 FDA decisions under this applicant name. See the company

  • K103433F20Teknimed, S.A. · 2011
  • K090435VertecemTeknimed, S.A. · 2009
  • K083005NangelTeknimed, S.A. · 2009
  • K080873Opacity + Bone CementTeknimed, S.A. · 2008
  • K062102OdoncerTeknimed, S.A. · 2007

Recent decisions in MQV

The MQV category page

  • K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc. · 2026
  • K260364Device 300419 StripGeistlich Pharma AG · 2026
  • K252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd. · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K253524Adaptos®Fuse Bone GraftBiomendex OY · 2026

https://510kreport.com/device/K041493 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041493: Cementek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041493

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026