510(k) · Cleared
ClearedMesh Fenestrated Introducer Needle (Mesh 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 Dec 21, 2007 as substantially equivalent to K060300 (Disc-O-Tech Medical Technologies, Ltd., 2006) and 4 other predicates after a 219-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Dec 21, 2007
- Review
- 219 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K002652 (2001). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
- 6 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
- 5 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
- 4 generations backK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
- 3 generations backK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
- 2 generations backK062424 Confidence EX High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006
- 1 generation backK063067 Confidence Fenestrated Introducer NeedleDisc-O-Tech Medical Technologies, Ltd. · 2006
- This deviceK071375 Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)Disc-O-Tech Medical Technologies, Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002652 | Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii | Stryker Corp. | 2001 | 1 |
| −6 | K033801 | Kyphx HV-R, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −5 | K041584 | Kyphx HV-R Bone Cement, Model C01A | Kyphon, Inc. | 2004 | 2 |
| −4 | K042691 | Vertefix Vertebroplasty Procedure Set | Cook, Inc. | 2005 | — |
| −3 | K060300 | Confidence High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | 8 |
| −2 | K062424 | Confidence EX High Viscosity Bone Cement | Disc-O-Tech Medical Technologies, Ltd. | 2006 | — |
| −1 | K063067 | Confidence Fenestrated Introducer Needle | Disc-O-Tech Medical Technologies, Ltd. | 2006 | — |
| 0 (this device) | 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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 3 | 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 |
|---|---|---|---|
| * | K060300 | Confidence High Viscosity Bone CementSummary page 2…gies Ltd. Mesh Introducer Needle Special 510(k) Classification Name Orthopedic Manual Surgical Instnument Predicate Devices V/Confidence High Viscosity Bone Cements (K060300, K062424) V/Confidence Fenestrated Introducer Needle (K063067) VSuper Revo®) HereulineTM Suture Anchor, by Linvatec Corporatio… | 2006 |
| * | K062424 | Confidence EX High Viscosity Bone CementSummary page 2…Mesh Introducer Needle Special 510(k) Classification Name Orthopedic Manual Surgical Instnument Predicate Devices V/Confidence High Viscosity Bone Cements (K060300, K062424) V/Confidence Fenestrated Introducer Needle (K063067) VSuper Revo®) HereulineTM Suture Anchor, by Linvatec Corporation (K04171… | 2006 |
| * | K063067 | Confidence Fenestrated Introducer NeedleSummary page 2…Name Orthopedic Manual Surgical Instnument Predicate Devices V/Confidence High Viscosity Bone Cements (K060300, K062424) V/Confidence Fenestrated Introducer Needle (K063067) VSuper Revo®) HereulineTM Suture Anchor, by Linvatec Corporation (K041713) (and Force FiberTM Polyethylene Nonabsorbable S… | 2006 |
| * | K041713 | Super Revo Herculine Suture AnchorSummary page 2…High Viscosity Bone Cements (K060300, K062424) V/Confidence Fenestrated Introducer Needle (K063067) VSuper Revo®) HereulineTM Suture Anchor, by Linvatec Corporation (K041713) (and Force FiberTM Polyethylene Nonabsorbable Surgical Suture, by Tele~lex Medical (K033654)). Intended Use The Mesh I… | 2004 |
| * | K033654 | Force FiberSummary page 2…VSuper Revo®) HereulineTM Suture Anchor, by Linvatec Corporation (K041713) (and Force FiberTM Polyethylene Nonabsorbable Surgical Suture, by Tele~lex Medical (K033654)). Intended Use The Mesh Introducer Needle is indicated for use in combination with the Confidence Bone Cement Delivery System.… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 5 of the 11 ancestors have a recall of any class.
- 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. 2007, 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 Mesh Introducer Needle is indicated for use in combination with the Confidence Bone Cement Delivery System. The Confidence Bone Cement Delivery System is intended for percutaneous delivery of Confidence Bone Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071375 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071375: Mesh Fenestrated Introducer Needle (Mesh 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/K071375
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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