# K213129: Restoration Modular 115mm Conical Distal Stem

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Dec 21, 2021 after 85 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K921308 (1994). 16 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013106: 2 Piece Modular Hip Stem, Howmedica Osteonics Corp. (2002) Summary page 5.
- K022549: Restoration Modular System, Howmedica Osteonics Corp. (2002) Summary page 5.
- K121308: Hip Systems, Howmedica Osteonics Corp. (2012) Summary page 5.

## Most influential descendants
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 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
- K250375: Allure Hip Stem and Intramedullary Plugs (2025), 0 descendants of its own

## Indications for use
Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed; and, Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press-fit into the proximal femur.

Source page: https://510kreport.com/device/K213129
Methodology: https://510kreport.com/methodology