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Kyphon, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
9
FDA recalls
6

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Kyphon, Inc. makes

Kyphon, Inc. manufactures spinal intervention devices, including disposable catheter systems for discography and bone cement delivery, such as the Discyphor Catheter System and Functional Anaesthetic Discography (FAD) Catheter System. The company also produces inflatable bone tamps—single-use tools like the KyphX Inflatable Bone Tamp and Directional Inflatable Bone Tamp—for vertebral body augmentation procedures. Bone cement formulations, such as KyphX HV-R, are designed for vertebral augmentation, alongside specialized introducer needles and direct catheter systems for targeted spinal interventions.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device authorization requirements. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue9

Newest first, rows 1-9 of 9

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 6 recalls initiated by Kyphon, Inc., the earliest on 2003-10-13 and the most recent on 2008-06-23. By recorded status: 6 terminated. The reasons filed fall into these groups: sterility or contamination, packaging and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2008

    • 23 Jun 2008 Z-2347-2008 Unclassified (pre-2012) Terminated Some products may contain the incorrect introducer stylet. If the treating physician is unfamiliar with the use and design of the diamond tip stylet, there is a possibility of serious injuring occurring with the use of the diamond tip stylet during balloon kyphoplasty procedure. Other risks include delay to surgery and inconvenience to patient. Distribution: Class II Recall - Nationwide Distribution.
    • 30 Jan 2008 Z-1765-2008 Unclassified (pre-2012) Terminated Physician instructions revised due to product breakage: During the implantation of the X-STOP IPD Device, the product has the potential to cause damage to and/or breakage of the X-STOP IPD Device's universal wing assembly. This includes the potential for breakage of the wing screw. Distribution: Worldwide distribution: USA, UK, Netherlands, Canada, Australia, Denmark, Germany, Greece, Hong Kong, Israel, Italy,…
      Full distribution text Worldwide distribution: USA, UK, Netherlands, Canada, Australia, Denmark, Germany, Greece, Hong Kong, Israel, Italy, Philippines, Portugal, Singapore, South Africa, Spain Switzerland, Turkey and UAE.
      Submission number: P040001

  • 2006

    • 25 Apr 2006 Z-0948-2008 Unclassified (pre-2012) Terminated Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure. Distribution: Nationwide including states of AL, AZ, CA, FL, IN, NH, NY, DC, ME, MD, WI, and PA. Submission number: K043500
    • 25 Apr 2006 Z-0949-2008 Unclassified (pre-2012) Terminated Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure. Distribution: Nationwide including states of AL, AZ, CA, FL, IN, NH, NY, DC, ME, MD, WI, and PA.

  • 2003

    • 13 Oct 2003 Z-0146-04 Unclassified (pre-2012) Terminated Devices for which sterility may be compromised as evidenced by a loss of package integrity. Distribution: There were a total of 188 direct customers that received the recalled product distributed by Kyphon. There were 0 (zero)…
      Full distribution text There were a total of 188 direct customers that received the recalled product distributed by Kyphon. There were 0 (zero) wholesaler dealers, distributors, retailers that received the recalled product distributed by Kyphon. The recalled product was distributed in the United States only. Recalled product was distributed by Kyphon to one VA hospital, VA Medical Center of San Diego, 3350 La Jolla Village Dr. San Diego, CA 92161. There were no shipments to foreign or Canadian distribution.
      Submission number: K011811
    • 13 Oct 2003 Z-0147-04 Unclassified (pre-2012) Terminated Devices for which sterility may be compromised as evidenced by a loss of package integrity. Distribution: There were a total of 188 direct customers that received the recalled product distributed by Kyphon. There were 0 (zero)…
      Full distribution text There were a total of 188 direct customers that received the recalled product distributed by Kyphon. There were 0 (zero) wholesaler dealers, distributors, retailers that received the recalled product distributed by Kyphon. The recalled product was distributed in the United States only. Recalled product was distributed by Kyphon to one VA hospital, VA Medical Center of San Diego, 3350 La Jolla Village Dr. San Diego, CA 92161. There were no shipments to foreign or Canadian distribution.

Frequently asked questions

How many devices does Kyphon, Inc. have in the registry?

The registry currently lists 9 devices for Kyphon, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Kyphon, Inc.'s devices?

Among its 9 most recently registered devices, Kyphon, Inc. has devices listed in FDA 510(k) (9 devices).

What risk classes do Kyphon, Inc.'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Kyphon, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Kyphon, Inc.?

FDA recall records list 6 recalls initiated by Kyphon, Inc., the most recent initiated on 2008-06-23. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Kyphon, Inc. in the registry?

The most recently registered devices listed for Kyphon, Inc. include DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B, DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR, KYPHX HV-R BONE CEMENT, MODEL C01A and KYPHON INFLATABLE BONE TAMP.

Generated automatically from registry data and not verified by a human reviewer.