# K951671: Osteonics Restoration Monolithic II Slotted Hip Stem Series

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Sep 6, 1995 after 148 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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.
154 later devices descend from it; 1 cites it directly.
0 of 155 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
- K972893: Partnership Revision  Femoral Stems (1997), 153 descendants of its own
- K983404: Type 3 Femoral Components (1998), 102 descendants of its own
- K013106: 2 Piece Modular Hip Stem (2002), 101 descendants of its own
- K001449: Trident Acetabular Shells: PS (2000), 69 descendants of its own
- K013676: Trident Hemispherical Acetabular Shells (2001), 68 descendants of its own

## Recalls of this device
- Oct 27, 2011 · Not classified · Z-1677-2012: An incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8.

Source page: https://510kreport.com/device/K951671
Methodology: https://510kreport.com/methodology