510(k) Report

510(k) · Cleared

Cleared

Smartmix Cemvac Pre-Filled with Smartset HV Bone Cement

K053445510(k) TraditionalCleared Jan 6, 200625-day reviewClass II21 CFR 888.3027

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

DePuy Orthopaedics, Inc. · LOD Bone Cement

Cleared on Jan 6, 2006 as substantially equivalent to K023012 (DePuy Orthopaedics, Inc., 2003) and 3 other predicates after a 25-day review. Its family tree reaches back 5 generations to 1984.

Decided
Jan 6, 2006
Review
25 days
Class
Class II
Product code
LOD
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to P810020 (1984). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2004: 1 other ancestor2003: 2 other ancestors2001: 2 other ancestors1997: 1 other ancestorP810020 · Palacos R Bone Cement · Smith & Nephew Richards, Inc. · 1984 · recalledK023012 · Smartset HV Bone Cement · DePuy Orthopaedics, Inc. · 2003K033563 · Smartset GHV Gentamicin Bone Cement · DePuy Orthopaedics, Inc. · 2004 · recalledK041656 · Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin Bone Cement · DePuy Orthopaedics, Inc. · 2004K042591 · Smartmix Pre-Filled Mixing System · DePuy Orthopaedics, Inc. · 2004198019851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors K042591 · Smartmix Pre-Filled Mixing System · DePuy Orthopaedics, Inc. · 2004K041656 · Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin Bone Cement · DePuy Orthopaedics, Inc. · 2004K033563 · Smartset GHV Gentamicin Bone Cement · DePuy Orthopaedics, Inc. · 2004 · recalledK023012 · Smartset HV Bone Cement · DePuy Orthopaedics, Inc. · 2003P810020 · Palacos R Bone Cement · Smith & Nephew Richards, Inc. · 1984 · recalled−50
  1. Root · 5 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
  2. 4 generations backK023012 Smartset HV Bone CementDePuy Orthopaedics, Inc. · 2003
  3. 3 generations backK033563 Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004 · Recalled
  4. 2 generations backK041656 Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV…DePuy Orthopaedics, Inc. · 2004
  5. 1 generation backK042591 Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc. · 2004
  6. This deviceK053445 Smartmix Cemvac Pre-Filled with Smartset HV Bone CementDePuy Orthopaedics, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5P810020Palacos R Bone CementSmith & Nephew Richards, Inc.19841
−4K023012Smartset HV Bone CementDePuy Orthopaedics, Inc.2003—
−3K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc.20041
−2K041656Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance…DePuy Orthopaedics, Inc.2004—
−1K042591Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc.2004—
0 (this device)K053445Smartmix Cemvac Pre-Filled with Smartset HV Bone CementDePuy Orthopaedics, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200120
200210
200320
200410
FIG. 1 — Lineage of K053445, 1984–2006Source: 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 LOD? 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 LOD device

  1. #1 K254107 Refobacin Bone Cement R (110034355)score 11.8 · 3 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? (4)

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
*K023012Smartset HV Bone Cement
Summary page 1
….3027 Cement Mixer for Clinical Use: Class I Exempt per CFR 888.4210 Cement Dispenser: Class [ Exempt per 21 CFR 888.4200 LOD, MBRB, KIH, IDZ SmartSet HV Bone Cement: K023012 SmartSet GHV Gentamicin Bone Cement: K033563 SmartMix Pre-filled Mixing System K042591 Cemvac Ultra Pre-packed with DePuy | Bo…
DePuy Orthopaedics, Inc.2003—
*K033563Smartset GHV Gentamicin Bone Cement
Summary page 1
…Exempt per CFR 888.4210 Cement Dispenser: Class [ Exempt per 21 CFR 888.4200 LOD, MBRB, KIH, IDZ SmartSet HV Bone Cement: K023012 SmartSet GHV Gentamicin Bone Cement: K033563 SmartMix Pre-filled Mixing System K042591 Cemvac Ultra Pre-packed with DePuy | Bone Cement K021499 DEVICE DESCR…
DePuy Orthopaedics, Inc.20041
*K042591Smartmix Pre-Filled Mixing System
Summary page 1
…Class [ Exempt per 21 CFR 888.4200 LOD, MBRB, KIH, IDZ SmartSet HV Bone Cement: K023012 SmartSet GHV Gentamicin Bone Cement: K033563 SmartMix Pre-filled Mixing System K042591 Cemvac Ultra Pre-packed with DePuy | Bone Cement K021499 DEVICE DESCRIPTIONS AND INDICATIONS: SmartMix Cemrac i…
DePuy Orthopaedics, Inc.2004—
*K021499Cemvac Ultra Pre-Packed with Depuy 1 Bone Cement
Summary page 1
…artSet HV Bone Cement: K023012 SmartSet GHV Gentamicin Bone Cement: K033563 SmartMix Pre-filled Mixing System K042591 Cemvac Ultra Pre-packed with DePuy | Bone Cement K021499 DEVICE DESCRIPTIONS AND INDICATIONS: SmartMix Cemrac i's a vacuum mixing and syringe delivery system pre-packed…
DePuy Orthopaedics, Inc.2002—

Also cleared against K023012: 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?

  • The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 12 months on median.
  • 4 of the 12 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K023012.

How does its category compare?

All LOD devices

LOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LOD

1in 2025

2007: 22008: 12009: 32013: 22014: 12015: 42016: 12017: 32018: 22019: 42020: 32021: 42022: 32023: 22024: 12025: 12026 (partial year): 1
2007high 4 (2015) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOD

277in 2022

2009: 103 days median2015: 138 days median2017: 96 days median2019: 90 days median2020: 139 days median2021: 95 days median2022: 277 days median
2007high 277 (2022) · low 90 (2019)2026

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

Recalls per year · LOD

2in 2022

2014: 12017: 42020: 12022: 22026 (partial year): 2
2007high 4 (2017) · low 0 (2007)2026

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

Adverse event reports per year · LOD

355in 2025

2007: 782008: 1342009: 1702010: 2912011: 4282012: 4122013: 5012014: 4652015: 5292016: 6152017: 8172018: 1,2952019: 2,3072020: 1,2942021: 7822022: 4722023: 4752024: 4922025: 355
2007high 2,307 (2019) · low 78 (2007)2025

MAUDE reports naming product code LOD, 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
20072—078
20081—0134
200931030170
20100—0291
20110—0428
20120—0412
20132—0501
20141—1465
201541380529
20161—0615
20173964817
20182—01,295
201949002,307
2020313911,294
20214950782
202232772472
20232—0475
20241—0492
20251—0355
20261—2—

What is it indicated for?

SmartSet HV Bone Cement is indicated for the Fixation of prostheses to living bone in orthopaedic musctloskeletal surgical procedures for rheumatoid arthritis, osteoarthritis. traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

SmartSet GHV Gentamicin Bone Cement is indicated for use in the second stagzc of a tvo-stage revision for total joint arthroplasty after the initial infection has been cleared

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K023012

2 other devices cite the same predicate.

  • K081155Smartset MV Bone CementDePuy Orthopaedics, Inc. · 2008
  • K033563Smartset GHV Gentamicin Bone CementDePuy Orthopaedics, Inc. · 20041 recall

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

Recent decisions in LOD

The LOD category page

  • K254107Refobacin Bone Cement R (110034355)Biomet France · 2026
  • K250760SPECTRUM GV Bone CementOsteoremedies, LLC · 2025
  • K241674Osteopal® VHeraeus Medical GmbH · 2024
  • K231556SPECTRUM® GV Bone CementOsteoremedies, LLC · 2023
  • K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A. · 2023

https://510kreport.com/device/K053445 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053445: Smartmix Cemvac Pre-Filled with Smartset HV Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053445

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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