# K142462: Restoration Anatomic Shell

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Nov 14, 2014 after 73 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K905258 (1991). 2 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010170: Trident Porous Titanium Acetabular Component, Howmedica Osteonics Corp. (2001) Summary page 4.
- K905258: S-Rom Oblong Acetabular Cup, Joint Medical Products Corp. (1991) Summary page 4.

## Most influential descendants
- K151264: Restoration Anatomic Shell (2015), 18 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own

## Indications for use
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. The Restoration® Anatomic Shell is indicated for cementless use only.

Source page: https://510kreport.com/device/K142462
Methodology: https://510kreport.com/methodology