# K981251: Kyphon Inflatable Bone Tamp

- Pathway: 510(k) (Traditional)
- Applicant: Kyphon, Inc.
- Decided: Jul 2, 1998 after 87 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
124 later devices descend from it; 14 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) currently marketed bone tamps: named in the summary without a submission number
- (no number) elevators: named in the summary without a submission number
- (no number) curettes: named in the summary without a submission number
- (no number) GSI Surgical Dissector: named in the summary without a submission number
- (no number) Koros Microdiscectomy Currette: named in the summary without a submission number

## Most influential descendants
- K032212: Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A (2003), 77 descendants of its own
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A (2004), 73 descendants of its own
- K072302: Entellus Medical RS-Series System (2008), 44 descendants of its own
- K081542: Modification to Entellus Medical RS-Series System (2008), 42 descendants of its own
- K093007: Entellus Medical Balloon Device (2010), 41 descendants of its own

## Recalls of this device
- Apr 24, 2020 · Class II · Z-2389-2020: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required sur
- Apr 24, 2020 · Class II · Z-2391-2020: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required sur
- Apr 24, 2020 · Class II · Z-2390-2020: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required sur

## Indications for use
Kyphon Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction for fractures and/or creation of a void in cancellous bone.

Source page: https://510kreport.com/device/K981251
Methodology: https://510kreport.com/methodology