510(k) Report

FDA applicant

Kyphon, Inc.

Sunnyvale, CA9 decisions1998–20087 recalls

FDA records 9 decisions for Kyphon, Inc. (Sunnyvale, CA) from 1998 to 2008: 9 510(k) clearances. Most are in product codes HRX (Arthroscope) and BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). Its devices cite 14 predicates, 8 of them its own earlier devices. 7 recalls are linked to its devices.

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

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Kyphon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

3in 2020

2009: 32011: 12020: 3
2007high 3 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Kyphon, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kyphon, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HRXArthroscope4decisions
  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)3decisions
  • NDNCement, Bone, Vertebroplasty2decisions

Whose devices does it build on?

Its devices cite 14 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 68 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K041454Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 200423cite it
  • K981251Kyphon Inflatable Bone TampKyphon, Inc. · 199814cite it
  • K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 200410cite it
  • K010246Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02AKyphon, Inc. · 20018cite it
  • K033801Kyphx HV-R, Model C01AKyphon, Inc. · 20046cite it
  • K032212Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 20034cite it

What has FDA decided for it lately?

  • K073516Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, RegularKyphon, Inc. · 2008
  • K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BKyphon, Inc. · 2007
  • K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer Needle, Model D01BKyphon, Inc. · 2006
  • K041454Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 20045 recalls
  • K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 20042 recalls
  • K033801Kyphx HV-R, Model C01AKyphon, Inc. · 20042 recalls
  • K032212Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
  • K010246Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02AKyphon, Inc. · 20013 recalls

All 9 as Kyphon, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K041454Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and…Apr 24, 2020Class II
  • K041454Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and…Apr 24, 2020Class II
  • K041454Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and…Apr 24, 2020Class II
  • K011811Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer…Mar 23, 2011
  • K033801Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit…Nov 10, 2009
  • K033801Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a…Nov 10, 2009