510(k) Report

510(k) · Cleared

Recalled · Class III · 2022

Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii

K002652510(k) TraditionalCleared Jan 26, 2001154-day reviewClass II21 CFR 888.3027Recalls 1

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

Stryker Corp. · LOD Bone Cement

Cleared on Jan 26, 2001 after a 154-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 216 later devices descend from it. It has been recalled once.

Decided
Jan 26, 2001
Review
154 days
Class
Class II
Product code
LOD
Recalls
1
Predicates
0

216 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2004: 3 descendants cleared2005: 4 descendants cleared2002: 1 descendant cleared2006: 8 descendants cleared2011: 5 descendants cleared2010: 2 descendants cleared2013: 2 descendants cleared2019: 8 descendants cleared2014: 2 descendants cleared2007: 10 descendants cleared2018: 9 descendants cleared2017: 7 descendants cleared2024: 24 descendants cleared2009: 2 descendants cleared2008: 1 descendant cleared2020: 16 descendants cleared2015: 2 descendants cleared2022: 16 descendants cleared2023: 26 descendants cleared2012: 1 descendant cleared2016: 3 descendants cleared2026: 28 descendants cleared2025: 21 descendants cleared2021: 15 descendants cleared200020052010201520202025
  1. This deviceK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001
  2. Descendant · cites it directly · 212 of its ownK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
  3. Descendant · cites it directly · 209 of its ownK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
  4. Descendant · 2 generations on · 189 of its ownK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
  5. Descendant · 2 generations on · 176 of its ownK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
  6. Descendant · 2 generations on · 167 of its ownK093828 Kyph X HV-R Bone CementMedtronic, Inc. · 2010

Showing 5 of 216 descendants. See all descendants

Descendants cleared per year

2002: 12004: 32005: 42006: 82007: 102008: 12009: 22010: 22011: 52012: 12013: 22014: 22015: 22016: 32017: 72018: 92019: 82020: 162021: 152022: 162023: 262024: 242025: 212026: 28
2002high 28 (2026) · low 0 (2003)2026

Most influential descendants

Showing 5 of 216 · See all
  • K033801Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · cites it directly212descendants
  • K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · cites it directly209descendants
  • K042691Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005 · 2 generations on189descendants
  • K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · 2 generations on176descendants
  • K093828Kyph X HV-R Bone CementMedtronic, Inc. · 2010 · 2 generations on167descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002652Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp.2001—
+1K033801Kyphx HV-R, Model C01AKyphon, Inc.20042
+1K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc.20042
+2K042691Vertefix Vertebroplasty Procedure SetCook, Inc.2005—
+2K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd.20068
+2K093828Kyph X HV-R Bone CementMedtronic, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200430
200540
200680
2007100
200810
200920
201020
201150
201210
201320
201420
201520
201630
201770
201890
201980
2020160
2021150
2022160
2023260
2024240
2025210
2026280
FIG. 1 — Lineage of K002652, 2001–2026Source: 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 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?

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

What descends from it? (216)

See all 216

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033801Kyphx HV-R, Model C01AKyphon, Inc.2004212
K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc.2004209
K043406Vertebroplastic Radiopaque Bone CementDepuy Spine, Inc.20053
K021499Cemvac Ultra Pre-Packed with Depuy 1 Bone CementDePuy Orthopaedics, Inc.20022

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 7, 2022Class IIIZ-0736-2023Under Investigation by firmInstructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033801 (Kyphon, Inc., 2004) has gone furthest, with 212 descendants of its own.

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—

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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
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https://510kreport.com/device/K002652 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002652: Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002652

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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