510(k) · Cleared
ClearedF20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teknimed, S.A. · NDN Cement, Bone, Vertebroplasty
Cleared on Jan 3, 2011 as substantially equivalent to K090435 (Teknimed, S.A., 2009) and 2 other predicates after a 40-day review. Its family tree reaches back 5 generations to 2001. 18 later devices descend from it.
- Decided
- Jan 3, 2011
- Review
- 40 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K002652 (2001). 8 ancestors in all, the oldest K003294 (2000). 18 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 4 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 3 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 2 generations backK043593 Spine-Fix Biomimetic Bone CementTeknimed, S.A. · 2006
- 1 generation backK080873 Opacity + Bone CementTeknimed, S.A. · 2008
- This deviceK103433 F20Teknimed, S.A. · 2011
- Descendant · cites it directly · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- Descendant · 2 generations on · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- Descendant · 3 generations on · 4 of its ownK242364 IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024
- Descendant · 2 generations on · 3 of its ownK232044 Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK241519 Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · cites it directly14descendants
- K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · 2 generations on11descendants
- K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024 · 3 generations on4descendants
- K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc. · 2023 · 2 generations on3descendants
- K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −4 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −3 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −2 | K043593 | Spine-Fix Biomimetic Bone Cement | Teknimed, S.A. | 2006 | — |
| −1 | K080873 | Opacity + Bone Cement | Teknimed, S.A. | 2008 | — |
| 0 (this device) | K103433 | F20 | Teknimed, S.A. | 2011 | — |
| +1 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| +2 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| +3 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | — |
| +2 | K232044 | Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. | 2023 | — |
| +3 | K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 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? (3)
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 |
|---|---|---|---|
| * | K090435 | VertecemSummary page 1…NON 3. Predicate or legally marketed devices which are substantially equivalent: F20 is a modification of the following bone cements: Vertecem (K090435, Teknimed) Opacity+ (K080873, Teknimed) Spine-Fix* (K045593, Teknimed) 4. Description of the device:… | 2009 |
| * | K080873 | Opacity + Bone CementSummary page 1…marketed devices which are substantially equivalent: F20 is a modification of the following bone cements: Vertecem (K090435, Teknimed) Opacity+ (K080873, Teknimed) Spine-Fix* (K045593, Teknimed) 4. Description of the device: The purpose of this submission… | 2008 |
| * | K043593 | Spine-Fix Biomimetic Bone Cement Our reading of the summary gave K045593, which is not a number in FDA’s lists. Corrected to the only number one digit away that is an earlier device of this one’s maker, Teknimed, S.A., in this field. | 2006 |
What descends from it? (18)
See all 182 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 10 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K221926 (Alphatec Spine, Inc., 2022) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K090435.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The F20 is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103433 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103433: F20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103433
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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