510(k) · Cleared
Recalled · Class II · 2017Confidence High Viscosity Bone Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disc-O-Tech Medical Technologies, Ltd. · NDN Cement, Bone, Vertebroplasty
Cleared on Jun 21, 2006 as substantially equivalent to K041584 (Kyphon, Inc., 2004) and 2 other predicates after a 135-day review. Its family tree reaches back 4 generations to 2001. 176 later devices descend from it. It has been recalled 8 times.
- Decided
- Jun 21, 2006
- Review
- 135 days
- Class
- Class II
- Product code
- NDN
- Recalls
- 8
- Predicates
- 3
Its longest line of descent runs back 4 generations to K002652 (2001). 5 ancestors in all. 176 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 3 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 2 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 1 generation backK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
- This deviceK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006
- Descendant · cites it directly · 165 of its ownK102397 Kyphon Xpede Bone CementMedtronic · 2011
- Descendant · 2 generations on · 162 of its ownK150460 KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015
- Descendant · 3 generations on · 159 of its ownK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- Descendant · 4 generations on · 106 of its ownK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- Descendant · 4 generations on · 91 of its ownK170347 CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017
Showing 5 of 176 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 176 · See all- K102397Kyphon Xpede Bone CementMedtronic · 2011 · cites it directly165descendants
- K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015 · 2 generations on162descendants
- K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016 · 3 generations on159descendants
- K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl · 2016 · 4 generations on106descendants
- K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017 · 4 generations on91descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −3 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −2 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −1 | K042691 | Vertefix Vertebroplasty Procedure Set | Cook, Inc. | 2005 | — |
| 0 (this device) | K060300 | Confidence High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | — |
| +1 | K102397 | Kyphon Xpede Bone Cement | Medtronic | 2011 | — |
| +2 | K150460 | KYPHON (R) HV-R (R) Bone Cement | Medtronic Sofamor Danck USA, Inc. | 2015 | — |
| +3 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016 | — |
| +4 | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated… | Medos International Sàrl | 2016 | — |
| +4 | K170347 | CD HORIZON™ Fenestrated Screw Set | Medtronic Sofamor Danek USA | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 15 | 0 |
| 2022 | 16 | 0 |
| 2023 | 25 | 0 |
| 2024 | 22 | 0 |
| 2025 | 20 | 0 |
| 2026 | 27 | 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 |
|---|---|---|---|
| * | K041584 | Kyphx HV-R Bone Cement, Model C01ASummary page 2…sification Name Filler, Bone Cement (For Vertebroplasty) Classification Class I1,per 21 CFR §888.3027 Predicate Devices v• Kyphon Inc.'s KyphX"' HV-RTM Bone Cement (K041584) ' Stryker Corp.'s Spineplex Tm Radiopaque Bone Cement (K032945) , Cook Inc.'s Vertefix Tm Radiopaque Bone Cement (K042691)… | 2004 |
| * | K032945 | Simplex XSummary page 2…ication Class I1,per 21 CFR §888.3027 Predicate Devices v• Kyphon Inc.'s KyphX"' HV-RTM Bone Cement (K041584) ' Stryker Corp.'s Spineplex Tm Radiopaque Bone Cement (K032945) , Cook Inc.'s Vertefix Tm Radiopaque Bone Cement (K042691) Intended Use The Disc-O-Tech Confidence High Viscosity Bone Cement… | 2004 |
| * | K042691 | Vertefix Vertebroplasty Procedure SetSummary page 2…• Kyphon Inc.'s KyphX"' HV-RTM Bone Cement (K041584) ' Stryker Corp.'s Spineplex Tm Radiopaque Bone Cement (K032945) , Cook Inc.'s Vertefix Tm Radiopaque Bone Cement (K042691) Intended Use The Disc-O-Tech Confidence High Viscosity Bone Cement is indicated for tile fixation of pathological fractures of… | 2005 |
What descends from it? (176)
See all 1767 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102397 | Kyphon Xpede Bone Cement | 2011 | 165 |
| K062424 | Confidence EX High Viscosity Bone Cement | 2006 | 7 |
| K063067 | Confidence Fenestrated Introducer Needle | 2006 | 4 |
| K201831 | CONFIDENCE Spinal Cement System | 2020 | 0 |
| K112907 | Confidence High Viscosity Spinal Cement, 16G / 20G | 2011 | 0 |
| K080108 | Cortoss Bone Augmentation Material | 2009 | 0 |
| K071375 | Mesh Fenestrated Introducer Needle (Mesh Introducer Needle) | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2017 | Class II | Z-1300-2018 | Nonconforming Material/Component | Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray. |
| Apr 17, 2013 | Class II | Z-2132-2013 | Process control | During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. |
| Apr 17, 2013 | Class II | Z-2133-2013 | Process control | During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. |
| Apr 17, 2013 | Class II | Z-2134-2013 | Process control | During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. |
| Jan 15, 2013 | Class II | Z-0960-2013 | Process control | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck |
| Jan 15, 2013 | Class II | Z-0962-2013 | Process control | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck |
| Jan 15, 2013 | Class II | Z-0961-2013 | Process control | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck |
| Jan 15, 2013 | Class II | Z-0963-2013 | Process control | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K102397 (Medtronic, 2011) has gone furthest, with 165 descendants of its own.
- 9 other devices also cite its predicate K041584.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Disc-O-Tech Confidence High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060300 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060300: Confidence High Viscosity Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060300
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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