510(k) · Cleared
ClearedConfidence Fenestrated Introducer Needle
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 Nov 3, 2006 as substantially equivalent to K060300 (Disc-O-Tech Medical Technologies, Ltd., 2006) and 1 other predicate after a 28-day review. Its family tree reaches back 6 generations to 2001. 4 later devices descend from it.
- Decided
- Nov 3, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K002652 (2001). 7 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 5 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 4 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 3 generations backK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
- 2 generations backK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
- 1 generation backK062424 Confidence EX High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006
- This deviceK063067 Confidence Fenestrated Introducer NeedleDisc-O-Tech Medical Technologies, Ltd. · 2006
- Descendant · cites it directly · 1 of its ownK070351 Space 360 Delivery SystemDfine, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK130402 Spider System Kolibri Cement NeedleSintea Plustek, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK090986 Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation…Dfine, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK071375 Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)Disc-O-Tech Medical Technologies, Ltd. · 2007
Most influential descendants
Showing 4 of 4 · See all- K070351Space 360 Delivery SystemDfine, Inc. · 2007 · cites it directly1descendant
- K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC · 2013 · cites it directly0descendants
- K090986Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/…Dfine, Inc. · 2009 · 2 generations on0descendants
- K071375Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)Disc-O-Tech Medical Technologies, Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −5 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −4 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −3 | K042691 | Vertefix Vertebroplasty Procedure Set | Cook, Inc. | 2005 | — |
| −2 | K060300 | Confidence High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | 8 |
| −1 | K062424 | Confidence EX High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | — |
| 0 (this device) | K063067 | Confidence Fenestrated Introducer Needle | Disc-O-Tech Medical Technologies, Ltd. | 2006 | — |
| +1 | K070351 | Space 360 Delivery System | Dfine, Inc. | 2007 | — |
| +1 | K130402 | Spider System Kolibri Cement Needle | Sintea Plustek, LLC | 2013 | — |
| +2 | K090986 | Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System… | Dfine, Inc. | 2009 | — |
| +1 | K071375 | Mesh Fenestrated Introducer Needle (Mesh Introducer Needle) | Disc-O-Tech Medical Technologies, Ltd. | 2007 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K060300 | Confidence High Viscosity Bone CementSummary page 2…e Fenestrated Introducer Needle Special 510(k) Classification Name Orthopedic Manual Surgical Instrument Predicate Devices ,/ Confidence High Viscosity Bone Cements (K060300, K062424) Intended Use The Confidence Bone Cement Delivery System is intended for percutaneous delivery of bone cement, during… | 2006 |
| * | K062424 | Confidence EX High Viscosity Bone CementSummary page 2…ated Introducer Needle Special 510(k) Classification Name Orthopedic Manual Surgical Instrument Predicate Devices ,/ Confidence High Viscosity Bone Cements (K060300, K062424) Intended Use The Confidence Bone Cement Delivery System is intended for percutaneous delivery of bone cement, during vertebrop… | 2006 |
What descends from it? (4)
3 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 5 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K070351 (Dfine, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K060300.
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 Confidence Cement Delivery System is intended for percutaneous delivery of Confidence bone cement, which is indicated for 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/K063067 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063067: Confidence Fenestrated Introducer Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063067
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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