# K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Aug 11, 2022 after 150 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K941847 (1994). 272 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 278 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211703: Insignia Hip Stem, Stryker Orthopaedics (2021) Summary page 5.
- K153345: Stryker Orthopaedics Hip Systems Labeling Update, Stryker Orthopaedics (2016) Summary page 6.
- K171768: Trident® II Acetabular System, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (2017) Summary page 6.
- K213129: Restoration Modular 115mm Conical Distal Stem, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2021) Summary page 6.

## Most influential descendants
- 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
- K250989: Stryker and Serf hip devices (2025), 0 descendants of its own

## Indications for use
Hip Arthroplasty Indications: Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure. Correction of functional deformity Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners: When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability. Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components: When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures. 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/K220731
Methodology: https://510kreport.com/methodology