# K943727: Biostop G Bone Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Landos, Inc.
- Decided: May 11, 1995 after 282 days
- Product code: LZN (Cement Obturator)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982918: Depuy C-Stem System (1998), 25 descendants of its own
- K042959: Depuy C-Stem Amt Hip Prosthesis (2004), 23 descendants of its own
- K082239: Depuy C-Stem Amt (2008), 14 descendants of its own
- K013350: Modification to Depuy C-Stem System (2001), 14 descendants of its own
- K220216: C-Stem AMT LE Prosthesis (2022), 8 descendants of its own

## Recalls of this device
- Dec 19, 2022 · Class II · Z-0951-2023: All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. 

Source page: https://510kreport.com/device/K943727
Methodology: https://510kreport.com/methodology