# Kyphon, Inc.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 9 (1998–2008): 9 510(k) clearances
- Product codes: HRX (4), BSP (3), NDN (2)
- Predicates its devices cite: 14 (8 its own); citations of its devices by later devices: 68 (8 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Innospine, Inc.: 3 (https://510kreport.com/company/innospine)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)

## Firms that cite its devices most
- Disc-O-Tech Medical Technologies, Ltd.: 9 (https://510kreport.com/company/disc-o-tech-medical-technologies)
- Medtronic, Inc.: 6 (https://510kreport.com/company/medtronic)
- Osseon Therapeutics, Inc.: 4 (https://510kreport.com/company/osseon-therapeutics)
- Care Fusion: 4 (https://510kreport.com/company/care-fusion)
- Bm Korea Co., Ltd.: 3 (https://510kreport.com/company/bm-korea)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)
- Tecres S.P.A.: 3 (https://510kreport.com/company/tecres)
- Imedicom Co., Ltd.: 3 (https://510kreport.com/company/imedicom)

## Its most-cited devices
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A (2004), cited by 23
- K981251: Kyphon Inflatable Bone Tamp (1998), cited by 14
- K041584: Kyphx HV-R Bone Cement, Model C01A (2004), cited by 10
- K010246: Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A (2001), cited by 8
- K033801: Kyphx HV-R, Model C01A (2004), cited by 6
- K032212: Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A (2003), cited by 4

## Recent decisions
- K073516: Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular (Feb 21, 2008)
- K063071: Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B (Apr 13, 2007)
- K061210: Functional  Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer Needle, Model D01B (Jun 27, 2006)
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A (Jul 9, 2004)
- K041584: Kyphx HV-R Bone Cement, Model C01A (Jul 7, 2004)
- K033801: Kyphx HV-R, Model C01A (Apr 1, 2004)
- K032212: Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A (Sep 15, 2003)
- K010246: Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp, Size 15/3, Model K02A (Feb 14, 2001)

Source page: https://510kreport.com/company/kyphon