510(k) · Cleared
Recalled · Class II · 2020Versabond AB Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LOD Bone Cement
Cleared on Apr 29, 2004 as substantially equivalent to K001160 (Smith & Nephew, Inc., 2000) and 4 other predicates after a 625-day review. Its family tree reaches back 3 generations to 1985. 1 of the 15 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Apr 29, 2004
- Review
- 625 days
- Class
- Class II
- Product code
- LOD
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 3 generations to K850247 (1985). 14 ancestors in all, the oldest P810020 (1984). No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK850247 Peritoneal Dialysis Coil CatheterSil-Med Corp. · 1985
- 2 generations backK961392 Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IISil-Med Corp. · 1997
- 1 generation backK012193 Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc. · 2002
- This deviceK022688 Versabond AB Bone CementSmith & Nephew, Inc. · 2004
Class I recalls in this family
- K900263 Antimicrobial Multi-Lumen Central Venous Catheter2 generations back · 1990
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850247 | Peritoneal Dialysis Coil Catheter | Sil-Med Corp. | 1985 | — |
| −2 | K961392 | Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II | Sil-Med Corp. | 1997 | — |
| −1 | K012193 | Amc Antimicrobial Pin/Wire Sleeve | Smith & Nephew, Inc. | 2002 | — |
| 0 (this device) | K022688 | Versabond AB Bone Cement | Smith & Nephew, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 1 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 2 | 0 |
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.
1 device in this family has a Class I recall. 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 K254107 Refobacin Bone Cement R (110034355)score 11.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001160 | Versabond Bone Cement | 2000 |
| * | K033509 | Modification to Versabond Bone Cement Cleared while this submission was under review Summary page 1…0086), marketed by Biomet, Inc., is a predicate device that uses the identical, but common Substantially Equivalent Device * VersaBond0 Bone Cement, K00'11 60 and K033509 [without antibiotic) - Smith & Nephew. Inc.… | 2003 |
| * | K012193 | Amc Antimicrobial Pin/Wire SleeveSummary page 1…mith & Nephew. Inc. Inc- * AMAC Antimicrobial Pin/Wire Sleeve, K012193 (for use of gentamicin antibiotic) - Smith & Nephew, * Surgical Simplex< PO', PMA N17004 (without antibiotic) - Howmedica Ost… | 2002 |
| Kept off the family tree | P17004 | Surgical Simplex P Number could not be read Summary page 1…Inc- * AMAC Antimicrobial Pin/Wire Sleeve, K012193 (for use of gentamicin antibiotic) - Smith & Nephew, * Surgical Simplex< PO', PMA N17004 (without antibiotic) - Howmedica Osteonics, Inc. & Palacoso G Bone Cement w/Gentamicin, K030086 - Biornet, Inc. * Palacos… | |
| * | K030086 | Palacos R Bone Cement with Gentamicin Cleared while this submission was under review Summary page 1…the antibiotic, Pa~iacose G Bone Cement with Gentamnicin antibiotic. (K030086), marketed by Biomet, Inc., is a predicate device that uses the identical, but common Substantially Equivalent Device * Ve… | 2003 |
| * | P810020 | Palacos R Bone CementSummary page 1…ex< PO', PMA N17004 (without antibiotic) - Howmedica Osteonics, Inc. & Palacoso G Bone Cement w/Gentamicin, K030086 - Biornet, Inc. * Palacos' RBone Cement, PMLA P810020 - EM Industries, Inc, Performance Characteristics Devica evaluation and testing has indicated that VersaBondPAB Bone Cement… | 1984 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2020 | Class II | Z-0933-2021 | Storage | Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 2 generations back · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 3 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K001160.
How does its category compare?
All LOD devicesLOD Bone Cement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOD
277in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOD
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOD
355in 2025
MAUDE reports naming product code LOD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 78 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 3 | 103 | 0 | 170 |
| 2010 | 0 | — | 0 | 291 |
| 2011 | 0 | — | 0 | 428 |
| 2012 | 0 | — | 0 | 412 |
| 2013 | 2 | — | 0 | 501 |
| 2014 | 1 | — | 1 | 465 |
| 2015 | 4 | 138 | 0 | 529 |
| 2016 | 1 | — | 0 | 615 |
| 2017 | 3 | 96 | 4 | 817 |
| 2018 | 2 | — | 0 | 1,295 |
| 2019 | 4 | 90 | 0 | 2,307 |
| 2020 | 3 | 139 | 1 | 1,294 |
| 2021 | 4 | 95 | 0 | 782 |
| 2022 | 3 | 277 | 2 | 472 |
| 2023 | 2 | — | 0 | 475 |
| 2024 | 1 | — | 0 | 492 |
| 2025 | 1 | — | 0 | 355 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
VersaBond AB Bone Cement with Gentamicin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022688: Versabond AB Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022688
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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