# K030903: Osteopal

- Pathway: 510(k) (Abbreviated)
- Applicant: Heraeus Kulzer GmbH & Co. KG
- Decided: Sep 23, 2003 after 183 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- 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 P810020 (1984). 1 ancestor in all.
40 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P810020: Palacos R Bone Cement, Smith & Nephew Richards, Inc. (1984) Summary page 1.

## Most influential descendants
- K050085: Osteopal V (2005), 38 descendants of its own
- K150408: V-Steady, V-Fast (2015), 28 descendants of its own
- K200596: G21 Cement, VADER® Pedicle System (2020), 27 descendants of its own
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own

## Indications for use
Osteopal is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Source page: https://510kreport.com/device/K030903
Methodology: https://510kreport.com/methodology