KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A

K041454 · Kyphon, Inc. · HRX · Jul 9, 2004 · Orthopedic

Device Facts

• Record ID: K041454
• Device Name: KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
• Applicant: Kyphon, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jul 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KyphX Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus.

Device Story

KyphX Inflatable Bone Tamps are surgical instruments featuring an inflatable distal component. Used by surgeons in clinical settings to reduce fractures or create voids in cancellous bone. The device is inserted into the target bone site; the distal balloon is inflated to mechanically displace bone and create a cavity or reduce a fracture. This void may subsequently be filled with bone cement (e.g., KyphX HV-R Bone Cement) during procedures like balloon kyphoplasty. The device facilitates minimally invasive orthopedic interventions, potentially restoring bone alignment and providing structural support.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use identical to previously cleared predicate devices.

Technological Characteristics

Inflatable bone tamp with an inflatable distal component. Mechanical device used for bone void creation and fracture reduction. No electronic, software, or energy-based components described.

Indications for Use

Indicated for patients requiring fracture reduction or void creation in cancellous bone of the spine, hand, tibia, radius, and calcaneus.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• KyphX® Directional Inflatable Bone Tamp (K032212)
• KyphX® Inflatable Bone Tamp (K010246)
• Kyphon Inflatable Bone Tamp (K981251)

Reference Devices

• KyphX® HV-R™ Bone Cement (K033801)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 2005

Ms. Cindy Domecus Vice President Clinical Research and Regulatory Affairs Kyphon Inc. 1221 Crossman Avenue Sunnyvale, California 94089

Re: K041454

Trade/Device Name: KyphX® Inflatable Bone Tamps Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: May 28, 2004 Received: June 1, 2004

Dear Ms. Domecus:

This letter corrects our substantially equivalent letter of July 9, 2004.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2- Ms. Cindy Domecus

This letter will allow you to continue marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small -Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Milkersen

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

Ko41454 510(k) Number (if known):

Device Name: KyphX® Inflatable Bone Tamps

Indications for Use:

KyphX Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus.

· Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Of Division of General, Restorative, and Neurological Devices

Page 1 of 1

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510(k) Number_ Koyluky

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K041454

Kyphon Inc. Page 1 of 1, Summary KyphX Inflatable Bone Tamps Premarket Notification [510(k)] Submission

## Premarket Notification [510(k)] Summary

| May 28, 2004 | JUL 09 2004 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Kyphx® Inflatable Bone Tamps |
| Common Name: | Inflatable Bone Tamp |
| Classification Name: | Tamp (per 21 CFR section 888.4540) and Arthroscope (per 21 CFR section 888.1100) |
| Manufacturer's Name:<br>Address: | Kyphon Inc.<br>1221 Crossman Avenue<br>Sunnyvale, CA 94089<br>[phone] |
| Contact Person: | Cindy Domecus<br>Vice President, Clinical Research & Regulatory Affairs |
| Predicate Device(s): | KyphX® Directional Inflatable Bone Tamp, K032212<br>KyphX® Inflatable Bone Tamp, K010246<br>Kyphon Inflatable Bone Tamp, K981251 |
| Device Description: | The KyphX® Inflatable Bone Tamps are the identified predicate devices. They are bone tamps with an inflatable component at the distal end. The products have the same technological characteristics and intended use as described for the predicates. Safety and effectiveness for use in kyphoplasty procedures is described in K033801. |
| Indication for Use: | KyphX® Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus. |

As with Kyphon's cleared Kyphx® inflatable Bone Tamp 510(k)s, K981251, K102046, and K03212, and Kyphon's cleared KyphX® HV-R™ Bone Cement 510(k), K033801, any statement regarding "substantial marketed without premarket approval or reclassification, and is not interpreted as an admission or any other type of evidence in any patent proceeding, including patent litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the scope of any patent or patent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a patentability perspective, from any of the other devices referenced in this filing.