# K011943: Impro Vise Absorbable Cement Flow Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corp.
- Decided: Sep 19, 2001 after 90 days
- Product code: LZN (Cement Obturator)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920118 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920118: Resorabplug, Sofamor Danek Mfg., Inc. (1993) Summary page 1.

## Most influential descendants
- K061465: Kmi Cement Restrictor Implant (2006), 0 descendants of its own
- K033953: Optimesh 500E Cement Restrictor (2004), 0 descendants of its own

## Indications for use
The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable bone cement flow restrictor plug for use in the intramedullary canal. This device is not intended for use in the spine,

Source page: https://510kreport.com/device/K011943
Methodology: https://510kreport.com/methodology