510(k) Report

510(k) · Cleared

Cleared

Parallax Balloon Inflatable Bone Tamp-10 MM Balloon Parallax Balloon Inflatable Bone Tamp-15 MM Balloon Parallax Balloon

K122503510(k) TraditionalCleared Jun 25, 2013313-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

Neuro Therm, Inc. · NDN Cement, Bone, Vertebroplasty

Cleared on Jun 25, 2013 as substantially equivalent to K101864 (Medtronic, 2010) and 2 other predicates after a 313-day review. Its family tree reaches back 4 generations to 1998.

Decided
Jun 25, 2013
Review
313 days
Class
Class II
Product code
NDN
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K981251 (1998). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestorK981251 · Kyphon Inflatable Bone Tamp · Kyphon, Inc. · 1998 · recalledK032212 · Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A · Kyphon, Inc. · 2003K041454 · Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A · Kyphon, Inc. · 2004 · recalledK101864 · Kyphon Xpander II Inflatable Bone Tamp · Medtronic · 201019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor K101864 · Kyphon Xpander II Inflatable Bone Tamp · Medtronic · 2010K041454 · Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A · Kyphon, Inc. · 2004 · recalledK032212 · Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A · Kyphon, Inc. · 2003K981251 · Kyphon Inflatable Bone Tamp · Kyphon, Inc. · 1998 · recalled0
  1. Root · 4 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
  2. 3 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
  3. 2 generations backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
  4. 1 generation backK101864 Kyphon Xpander II Inflatable Bone TampMedtronic · 2010
  5. This deviceK122503 Parallax Balloon Inflatable Bone Tamp-10 MM Balloon Parallax Balloon…Neuro Therm, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K981251Kyphon Inflatable Bone TampKyphon, Inc.19983
−3K032212Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc.2003—
−2K041454Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc.20045
−1K101864Kyphon Xpander II Inflatable Bone TampMedtronic2010—
0 (this device)K122503Parallax Balloon Inflatable Bone Tamp-10 MM Balloon Parallax Balloon…Neuro Therm, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K122503, 1998–2013Source: 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
*K101864Kyphon Xpander II Inflatable Bone Tamp
Summary page 1
…instrument, product code HXG (Tamp) Accessory to 21 CFR 888.3027, Cement/Bone Vertebroplasty, product code NDN C) PREDICATES: o Kyphon Xpander 1l Inflatable Bone Tamp K101864 e KyphX Inflatable Bone Tamp K010246 * KyphX Xpander Inflatable Bone Tamp K041454 D) DEVICE DESCRIPTION: The NeuroTherm Paralla…
Medtronic2010—
*K010246Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3…
Summary page 1
…Accessory to 21 CFR 888.3027, Cement/Bone Vertebroplasty, product code NDN C) PREDICATES: o Kyphon Xpander 1l Inflatable Bone Tamp K101864 e KyphX Inflatable Bone Tamp K010246 * KyphX Xpander Inflatable Bone Tamp K041454 D) DEVICE DESCRIPTION: The NeuroTherm Parallax Balloon Inflatable Bone Tamp is a b…
Kyphon, Inc.20013
*K041454Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A
Summary page 1
…tebroplasty, product code NDN C) PREDICATES: o Kyphon Xpander 1l Inflatable Bone Tamp K101864 e KyphX Inflatable Bone Tamp K010246 * KyphX Xpander Inflatable Bone Tamp K041454 D) DEVICE DESCRIPTION: The NeuroTherm Parallax Balloon Inflatable Bone Tamp is a bone tamp with an inflatable component at the…
Kyphon, Inc.20045

Also cleared against K101864: 1 other device →

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 15 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
  • 3 of the 5 ancestors have a recall of any class.
  • 1 other device also cites its predicate K101864.

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 NeuroTherm Parallax Balloon Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The Parallax Balloon Inflatable Bone Tamp is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K101864

1 other device cites the same predicate.

  • K123771Kyphon Express II Inflatable Bone TampsMedtronic · 2012

More from Neuro Therm, Inc.

3 FDA decisions under this applicant name. See the company

  • K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc. · 20114 recalls
  • K052878NT-1000Neuro Therm, Inc. · 2006

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/K122503 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122503: Parallax Balloon Inflatable Bone Tamp-10 MM Balloon Parallax Balloon Inflatable Bone Tamp-15 MM Balloon Parallax Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122503

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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