510(k) · Cleared
Recalled · Class II · 2021Cortoss Bone Augmentation Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthovita, Inc. · NDN Cement, Bone, Vertebroplasty
Cleared on Jun 5, 2009 as substantially equivalent to K032945 (Stryker Corp., 2004) and 4 other predicates after a 507-day review. Its family tree reaches back 10 generations to 1997. It has been recalled 4 times.
- Decided
- Jun 5, 2009
- Review
- 507 days
- Class
- Class II
- Product code
- NDN
- Recalls
- 4
- Predicates
- 5
Its longest line of descent runs back 10 generations to K970097 (1997). 44 ancestors in all, the oldest K803106 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 6 generations between
- 3 generations backK040612 Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd. · 2004
- 2 generations backK053336 Staxx FX SystemSpine Wave, Inc. · 2006
- 1 generation backK063606 Modification to Staxx FX SystemSpine Wave, Inc. · 2007
- This deviceK080108 Cortoss Bone Augmentation MaterialOrthovita, Inc. · 2009
Show all 10 generations
- Root · 10 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 9 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 8 generations backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 7 generations backK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
- 6 generations backK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
- 5 generations backK032358 B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd. · 2003
- 4 generations backK034037 Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd. · 2004
- 3 generations backK040612 Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd. · 2004
- 2 generations backK053336 Staxx FX SystemSpine Wave, Inc. · 2006
- 1 generation backK063606 Modification to Staxx FX SystemSpine Wave, Inc. · 2007
- This deviceK080108 Cortoss Bone Augmentation MaterialOrthovita, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −9 | K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −8 | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing… | Disco-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −7 | K021324 | Fixion Intramedullary Nailing System (Fixion IM Nailing System) | Disco-O-Tech Medical Technologies, Ltd. | 2002 | 1 |
| −6 | K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF… | Disco-O-Tech Medical Technologies, Ltd. | 2002 | — |
| −5 | K032358 | B-Twin Bone Expander System (B-Twin BE System) | Disc-O-Tech Medical Technologies, Ltd. | 2003 | — |
| −4 | K034037 | Sky Bone Expander System | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
| −3 | K040612 | Sky Bone Expander System (Sky System) | Disc-O-Tech Medical Technologies, Ltd. | 2004 | — |
| −2 | K053336 | Staxx FX System | Spine Wave, Inc. | 2006 | — |
| −1 | K063606 | Modification to Staxx FX System | Spine Wave, Inc. | 2007 | — |
| 0 (this device) | K080108 | Cortoss Bone Augmentation Material | Orthovita, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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.
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? (5)
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 |
|---|---|---|---|
| * | K032945 | Simplex XSummary page 1…ribution: Predicate Device Company FDA Clearance Number Spineplex Radiopaque Bone Cement Stryker K032945 Spine-Fix Biomimetic Bone Cement Teknimed K043593 Staxx Fx System Spi… | 2004 |
| * | K043593 | Spine-Fix Biomimetic Bone CementSummary page 1…FDA Clearance Number Spineplex Radiopaque Bone Cement Stryker K032945 Spine-Fix Biomimetic Bone Cement Teknimed K043593 Staxx Fx System Spine Wave K053336, K063606 Confidence High Viscosity Bone Cement… | 2006 |
| * | K053336 | Staxx FX SystemSummary page 1…ker K032945 Spine-Fix Biomimetic Bone Cement Teknimed K043593 Staxx Fx System Spine Wave K053336, K063606 Confidence High Viscosity Bone Cement Disc-O-Tech K060300 Cortoss has the same intended use and i… | 2006 |
| * | K063606 | Modification to Staxx FX SystemSummary page 1…K032945 Spine-Fix Biomimetic Bone Cement Teknimed K043593 Staxx Fx System Spine Wave K053336, K063606 Confidence High Viscosity Bone Cement Disc-O-Tech K060300 Cortoss has the same intended use and indication… | 2007 |
| * | K060300 | Confidence High Viscosity Bone CementSummary page 1…K043593 Staxx Fx System Spine Wave K053336, K063606 Confidence High Viscosity Bone Cement Disc-O-Tech K060300 Cortoss has the same intended use and indications, similar technological characteristics, and similar principles of operat… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2021 | Class II | Z-2101-2021 | Storage | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. |
| May 18, 2021 | Class II | Z-2100-2021 | Storage | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. |
| Apr 1, 2020 | Class II | Z-1900-2020 | Storage | Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism. |
| Mar 31, 2011 | Not classified | Z-3188-2011 | Packaging | Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and handling conditions. This abrasion may cause small holes or tears in the packaging… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 14 of the 44 ancestors have a recall of any class.
- 14 other devices also cite its predicate K032945.
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?
CORTOSS ® Bone Augmentation Material is indicated for the fixation of pathological fractures of the vertebral body using vertebral augmentation. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080108: Cortoss Bone Augmentation Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080108
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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