# K961101: Stryker Cement Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Jul 15, 1996 after 118 days
- Product code: LZV (System, Cement Removal Extraction)
- Device class: 2
- Regulation: 21 CFR 888.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 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 no predicate by number.

## Most influential descendants
- K021502: Oscar, Model OE3000 (2002), 7 descendants of its own
- K051053: Oscar, Model OE3000DB (2005), 3 descendants of its own
- K063531: Series 3 Lotus Laparoscopic Ultrasound Surgery System (2007), 2 descendants of its own
- K151101: Lotus Series 4 Ultrasonic Surgical System & Accessories (2015), 1 descendant of its own
- K083830: Oscar Bone Resector (2009), 1 descendant of its own

## Indications for use
The Stryker Cement Removal System (CRS) is indicated for use in revision hip arthroplasty to remove the old PMMA distal cement plug from the area between the distal tip of the primary implant and proximal to any bony restriction within the femoral canal.

Source page: https://510kreport.com/device/K961101
Methodology: https://510kreport.com/methodology