510(k) · Cleared
ClearedGeneration 4 Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LOD Bone Cement
Cleared on Dec 19, 2001 after a 768-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 28 later devices descend from it.
- Decided
- Dec 19, 2001
- Review
- 768 days
- Class
- Class II
- Product code
- LOD
- Recalls
- None
- Predicates
- 1
28 later devices descend from it, 2 citing it directly.
- This deviceK993836 Generation 4 Bone CementBiomet, Inc. · 2001
- Descendant · cites it directly · 23 of its ownK051532 Cobalt G HV Bone CementBiomet, Inc. · 2005
- Descendant · 2 generations on · 20 of its ownK062273 Spacer-G Temporary Hip ProsthesisTecres S.P.A. · 2008
- Descendant · 3 generations on · 19 of its ownK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
- Descendant · 4 generations on · 16 of its ownK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
- Descendant · 5 generations on · 5 of its ownK183017 Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K051532Cobalt G HV Bone CementBiomet, Inc. · 2005 · cites it directly23descendants
- K062273Spacer-G Temporary Hip ProsthesisTecres S.P.A. · 2008 · 2 generations on20descendants
- K101356Spacer-G and Spacer-KTecres S.P.A. · 2011 · 3 generations on19descendants
- K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012 · 4 generations on16descendants
- K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993836 | Generation 4 Bone Cement | Biomet, Inc. | 2001 | — |
| +1 | K051532 | Cobalt G HV Bone Cement | Biomet, Inc. | 2005 | — |
| +2 | K062273 | Spacer-G Temporary Hip Prosthesis | Tecres S.P.A. | 2008 | — |
| +3 | K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011 | — |
| +4 | K112470 | 2GC Hip/Knee Modular Spacer | Mandell Horwitz Consultants, LLC | 2012 | — |
| +5 | K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 7 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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.
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 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? (1)
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 |
|---|---|---|---|
| Kept off the family tree | P17004 | Surgical Simplex P Radiopaque Bone Cement Number could not be read Summary page 2…tions for use, intended use, technological characteristics and material. Predicate device: Surgical Simplex P Radiopaque Bone Cement Howmedica Corporation PMA Number: N17004 000366 “,.v"“'%.b o MEALTy %, ] {é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug… |
What descends from it? (28)
See all 282 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K051532 (Biomet, Inc., 2005) has gone furthest, with 23 descendants of its own.
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?
GENERATION 4 Bone Cement is intended for the fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for osteoarthritis, rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993836: Generation 4 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/K993836
Report an extraction error
Are you the manufacturer?
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