510(k) Report

510(k) · Cleared

Cleared

Spider System Kolibri Cement Needle

K130402510(k) SpecialCleared Apr 1, 201341-day reviewClass II21 CFR 888.3027

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sintea Plustek, LLC · NDN Cement, Bone, Vertebroplasty

Cleared on Apr 1, 2013 as substantially equivalent to K072198 (Sintea Biotech, Inc., 2008) and 2 other predicates after a 41-day review. Its family tree reaches back 7 generations to 2001.

Decided
Apr 1, 2013
Review
41 days
Class
Class II
Product code
NDN
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K002652 (2001). 25 ancestors in all, the oldest K890925 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2007: 2 other ancestors2004: 3 other ancestors2006: 2 other ancestors2003: 2 other ancestors2001: 2 other ancestors1998: 1 other ancestor2005: 2 other ancestors2002: 1 other ancestor1999: 1 other ancestor1989: 1 other ancestorK002652 · Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii · Stryker Corp. · 2001 · recalled×2: 2 generations cleared close together, K033801 (2004), K041584 (2004) K042691 · Vertefix Vertebroplasty Procedure Set · Cook, Inc. · 2005×3: 3 generations cleared close together, K060300 (2006), K062424 (2006), K063067 (2006) 1985199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 7 other ancestors4 generations back: 3 other ancestors5 generations back: 3 other ancestors6 generations back: 1 other ancestor K063067 · Confidence Fenestrated Introducer Needle · Disc-O-Tech Medical Technologies, Ltd. · 2006K062424 · Confidence EX High Viscosity Bone Cement · Disc-O-Tech Medical Technologies, Ltd. · 2006K060300 · Confidence High Viscosity Bone Cement · Disc-O-Tech Medical Technologies, Ltd. · 2006 · recalledK042691 · Vertefix Vertebroplasty Procedure Set · Cook, Inc. · 2005K041584 · Kyphx HV-R Bone Cement, Model C01A · Kyphon, Inc. · 2004 · recalledK033801 · Kyphx HV-R, Model C01A · Kyphon, Inc. · 2004 · recalledK002652 · Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii · Stryker Corp. · 2001 · recalled−50
  1. Root · 7 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
  2. 6 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
  3. 5 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
  4. 4 generations backK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
  5. 3 generations backK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
  6. 2 generations backK062424 Confidence EX High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006
  7. 1 generation backK063067 Confidence Fenestrated Introducer NeedleDisc-O-Tech Medical Technologies, Ltd. · 2006
  8. This deviceK130402 Spider System Kolibri Cement NeedleSintea Plustek, LLC · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K002652Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp.20011
−6K033801Kyphx HV-R, Model C01AKyphon, Inc.20042
−5K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc.20042
−4K042691Vertefix Vertebroplasty Procedure SetCook, Inc.2005—
−3K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd.20068
−2K062424Confidence EX High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd.2006—
−1K063067Confidence Fenestrated Introducer NeedleDisc-O-Tech Medical Technologies, Ltd.2006—
0 (this device)K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199810
199910
200120
200210
200320
200430
200520
200620
200720
200810
FIG. 1 — Lineage of K130402, 2001–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K072198X-Void, Spider
Summary page 1
…, FL 33139 305-673-6226 Purpose: The purpose of this submission is clearance of the Spider System KOLIBRI Cement Needle as an additional component to the Spider System (K072198). Device Description The needle has the following characteristics: * entirely cannulated needle; * threaded proximal end t…
Sintea Biotech, Inc.2008—
*K072133Avaflex Vertebral Augmentation Needle
Summary page 1
…lly equivalent to a legally marketed predicate device. The predicate device is the Sintea Spider System (K072198), Cardinal Health AVAflex Vertebral Augmentation Needle (K072133) and the Disc-O-Tech Confidence Bone Cement Needle (K063067).…
Cardinal Health, Inc.2007—
*K063067Confidence Fenestrated Introducer Needle
Summary page 1
…redicate device is the Sintea Spider System (K072198), Cardinal Health AVAflex Vertebral Augmentation Needle (K072133) and the Disc-O-Tech Confidence Bone Cement Needle (K063067). 27…
Disc-O-Tech Medical Technologies, Ltd.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)

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 12 years and passes through 5 companies; a new generation was cleared every 7 months on median.
  • 9 of the 25 ancestors have a recall of any class.

How does its category compare?

All NDN devices

NDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · NDN

2in 2025

2007: 92008: 12009: 62010: 52011: 112012: 72013: 72014: 72015: 62016: 42017: 52018: 32019: 22020: 42021: 22022: 22023: 22024: 32025: 22026 (partial year): 1
2007high 11 (2011) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NDN

90in 2024

2007: 128 days median2009: 211 days median2010: 215 days median2011: 164 days median2012: 90 days median2013: 118 days median2014: 106 days median2015: 76 days median2016: 154 days median2017: 125 days median2018: 111 days median2020: 157 days median2024: 90 days median
2007high 215 (2010) · low 76 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NDN

4in 2013

2009: 12013: 4
2007high 4 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NDN

626in 2025

2007: 212008: 392009: 702010: 3962011: 982012: 892013: 2422014: 2312015: 2042016: 1822017: 1912018: 1442019: 2272020: 2122021: 3442022: 2702023: 3112024: 4542025: 626
2007high 626 (2025) · low 21 (2007)2025

MAUDE reports naming product code NDN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079128021
20081—039
20096211170
201052150396
201111164098
2012790089
201371184242
201471060231
20156760204
201641540182
201751250191
201831110144
20192—0227
202041570212
20212—0344
20222—0270
20232—0311
20243900454
20252—0626
20261—0—

What is it indicated for?

The Spider System Kolibri Cement Needle is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

Indications for use as stated in the FDA summary.

More from Sintea Plustek, LLC

3 FDA decisions under this applicant name. See the company

  • K140787PLS (Posterior Lumbar System)Sintea Plustek, LLC · 2014
  • K112861Sintea Plustek Anterior Cervical Plate SystemSintea Plustek, LLC · 2012

Recent decisions in NDN

The NDN category page

  • K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed, Ltd. · 2026
  • K250637VCFix Spinal SystemAmber Implants · 2025
  • K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed, Ltd. · 2025
  • K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed, Ltd. · 2024
  • K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd. · 2024

https://510kreport.com/device/K130402 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130402: Spider System Kolibri Cement Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130402

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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