# K900438: MC2P Acetabular Component

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Apr 18, 1990 after 78 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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.
3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K243784: Stryker Orthopaedics Hip Devices Labeling Update (2025), 2 descendants of its own
- K261624: Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component (2026), 0 descendants of its own
- K250989: Stryker and Serf hip devices (2025), 0 descendants of its own

## Recalls of this device
- Jul 30, 2026 · Class II · Z-3196-2026: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which m

Source page: https://510kreport.com/device/K900438
Methodology: https://510kreport.com/methodology