# K243784: Stryker Orthopaedics Hip Devices Labeling Update

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Feb 6, 2025 after 59 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: 21 generations back to K941847 (1994). 321 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 323 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121308: Hip Systems, Howmedica Osteonics Corp. (2012) Summary page 8.
- K233498: Stryker Orthopaedics Hip Systems Labeling Update, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2023) Summary page 8.
- K974685: Osteonics Polyethylene Acetabular Components, Osteonics Corp. (1998) Summary page 8.
- K900438: MC2P Acetabular Component, Osteonics Corp. (1990) Summary page 8.

## Most influential descendants
- 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
Indications for Restoration Modular Hip System • 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. • The RESTORATION Modular Hip System is intended for 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. Indications for Accolade C, Accolade HFx, SYSTEM 12 CROSSFIRE, ACCOLADE DISTAL SPACER, CITATION TMZF, PCA Duration Insert, PCA Femoral Head • 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 Indications for Accolade II Stems The indications for use of the total hip replacement prostheses include: • 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 and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indication specific to use of ACCOLADE II Femoral 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 intraoperative instability. ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures. Indications for OMNIFIT SERIES Acetbular Inserts, Omnifit Crossfire10 Deg Inserts, Crossfire Eccentric Inserts, Omnifit Crossfire Inserts, Trident Crossfire Inserts, Trident X3 Inserts, Trident X3 Eccentric Inserts • 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 inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. Indications for ALL POLY CONSTRAINED INSERT, TRIDENT 0 DEG CONSTRAINED INSERT, TRIDENT CONSTRAINED INSERT A Constrained Acetabular Insert is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability. Indications for UHR Bipolar • Femoral head/neck fractures or non-unions. • Aseptic necrosis of the femoral head. • Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations: • Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. • Salvage of failed total hip arthroplasty Indications for Artisan Bone Plug These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cement in a cemented hip procedure. The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal. Indications for C-Taper Alumina Ceramic Heads, V40 Taper Alumina Ceramic Heads,Ceramic V40™ Femoral Head • 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 Indications for BIOLOX Delta Ceramic Heads, C-Taper to Universal Taper Adapter Sleeve, Universal V40™ Taper Adapter Sleeve For Use as a Total Hip Replacement: • Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. • Revision of previous cup arthroplasty or other procedures • 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 in the acetabulum. For Use as a Bipolar Hip Replacement • Femoral head/neck fractures or non-unions. • Aseptic necrosis of the femoral head. • Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion. • Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. • Salvage of failed total hip arthroplasty Indications for ADM/MDM X3 Inserts, MDM Acetabular Inserts, MDM Acetabular Liners The indications for use for total hip arthroplasty include: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Revision procedures where other treatments or devices have failed; and, 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. 6. Dislocation risks MDM Liners are intended for cementless use only.

Source page: https://510kreport.com/device/K243784
Methodology: https://510kreport.com/methodology