510(k) · Cleared
ClearedBonos Inject
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aap Biomaterials GmbH · NDN Cement, Bone, Vertebroplasty
Cleared on Apr 14, 2009 as substantially equivalent to K050085 (Heraeus Kulzer,GmbH, 2005) after a 50-day review. Its family tree reaches back 3 generations to 1984. 8 later devices descend from it.
- Decided
- Apr 14, 2009
- Review
- 50 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P810020 (1984). 8 later devices descend from it, 2 citing it directly.
- Root · 3 generations backP810020 Palacos R Bone CementSmith & Nephew Richards, Inc. · 1984 · Recalled
- 2 generations backK030903 OsteopalHeraeus Kulzer GmbH & Co. KG · 2003
- 1 generation backK050085 Osteopal VHeraeus Kulzer,GmbH · 2005
- This deviceK090460 Bonos InjectAap Biomaterials GmbH · 2009
- Descendant · cites it directly · 6 of its ownK202458 BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH · 2021
- Descendant · 2 generations on · 5 of its ownK212489 BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA · 2021
- Descendant · 3 generations on · 3 of its ownK222256 BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA · 2022
- Descendant · 4 generations on · 1 of its ownK231809 Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone…Ulrich Medical USA · 2023
- Descendant · 5 generations on · 0 of its ownK251719 Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH · 2021 · cites it directly6descendants
- K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA · 2021 · 2 generations on5descendants
- K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA · 2022 · 3 generations on3descendants
- K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA · 2023 · 4 generations on1descendant
- K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P810020 | Palacos R Bone Cement | Smith & Nephew Richards, Inc. | 1984 | 1 |
| −2 | K030903 | Osteopal | Heraeus Kulzer GmbH & Co. KG | 2003 | — |
| −1 | K050085 | Osteopal V | Heraeus Kulzer,GmbH | 2005 | — |
| 0 (this device) | K090460 | Bonos Inject | Aap Biomaterials GmbH | 2009 | — |
| +1 | K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | Osartis GmbH | 2021 | — |
| +2 | K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | 2021 | — |
| +3 | K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System™ | Neo Medical SA | 2022 | — |
| +4 | K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement… | Ulrich Medical USA | 2023 | — |
| +5 | K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 NDN? 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 NDN device
- #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050085 | Osteopal VSummary page 1…bstantial equivalence is claimed: Manufaturer Device Name 510(k)# Heraeus Kulzer GmnbH OSTEOPAL® V (K050085) Device description: BonOs® Inject is a radiopaque, injectable bone, cement for use in spine surgery like percutaneous verteb… | 2005 |
What descends from it? (8)
2 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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K202458 (Osartis GmbH, 2021) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K050085.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NDN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDN
90in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDN
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDN
626in 2025
MAUDE reports naming product code NDN, 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 | 9 | 128 | 0 | 21 |
| 2008 | 1 | — | 0 | 39 |
| 2009 | 6 | 211 | 1 | 70 |
| 2010 | 5 | 215 | 0 | 396 |
| 2011 | 11 | 164 | 0 | 98 |
| 2012 | 7 | 90 | 0 | 89 |
| 2013 | 7 | 118 | 4 | 242 |
| 2014 | 7 | 106 | 0 | 231 |
| 2015 | 6 | 76 | 0 | 204 |
| 2016 | 4 | 154 | 0 | 182 |
| 2017 | 5 | 125 | 0 | 191 |
| 2018 | 3 | 111 | 0 | 144 |
| 2019 | 2 | — | 0 | 227 |
| 2020 | 4 | 157 | 0 | 212 |
| 2021 | 2 | — | 0 | 344 |
| 2022 | 2 | — | 0 | 270 |
| 2023 | 2 | — | 0 | 311 |
| 2024 | 3 | 90 | 0 | 454 |
| 2025 | 2 | — | 0 | 626 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090460 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090460: Bonos Inject.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090460
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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