# K051363: Restoration Modular System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jun 23, 2005 after 29 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K212187: Restoration® Modular Hip System (2022), 5 descendants of its own
- K233498: Stryker Orthopaedics Hip Systems Labeling Update (2023), 4 descendants of its own
- 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

## Indications for use
The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. Examples of specific indications for use of the Restoration® Modular System include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Revision procedures where other treatments or devices have failed, and Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K051363
Methodology: https://510kreport.com/methodology