# K250989: Stryker and Serf hip devices

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp (Dba Stryker Orthopaedics)
- Decided: Jul 25, 2025 after 116 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: 22 generations back to K941847 (1994). 339 ancestors in all.
No later device cites it as a predicate yet.
0 of 339 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243784: Stryker Orthopaedics Hip Devices Labeling Update, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2025) Summary page 9.
- K233498: Stryker Orthopaedics Hip Systems Labeling Update, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2023) Summary page 10.
- K223745: Novae® Dual Mobility System, Hype® Hip System, Serf (2023) Summary page 10.
- K111572: Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility Acetabular Cup Model, Serf (2011) Summary page 10.

## Indications for use
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. • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic 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. When used with MDM Liners • Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. • Dislocation risks When used with Constrained Liner: • The Trident Constrained Acetabular Insert is indicated for use 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. The Trident II Acetabular Shells are indicated for cementless use only. The Restoration® Modular Hip System is indicated for use in: • 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 to be used 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. The indications for use for total hip arthroplasty with stems 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 fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indication specific to use of the Femoral Stem 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. The Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures. 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 the 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 intra- operative instability. The Stems are intended for cementless use only and are intended for total and hemiarthroplasty. • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic 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 HOWMEDICA OSTEONICS TRIDENT and TRITANIUM Acetabular Shells are intended for cementless use only. Dome hole plug is indicated for cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous • 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. 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 lnsignia 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 lnsignia 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. • 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. When used with MDM Liners • Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. • Dislocation risks When used with Constrained Liner: • The Trident Constrained Acetabular Insert is indicated for use 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. The Restoration® Anatomic Shell is indicated for cementless use only. • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic 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 femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. 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 The Novae® Dual Mobility and Hype® hip Systems are indicated for total hip replacement, which includes: - osteoarthritis, - femoral neck fracture, - dislocation risk, - osteonecrosis of the femoral head, - revision procedures where other treatments or devices have failed and if bone reconstruction so permits. • Sunfit TH, Novae® E TH, and Coptos TH acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use. • Hype® SCS, SCC, SCL, SCV, SCC Mini, and SCLA Mini hip stems are intended for press-fit use. The Novae® Dual Mobility and Hype® hip Systems are indicated for total hip replacement, which includes: - osteoarthritis, - femoral neck fracture, - dislocation risk, - osteonecrosis of the femoral head, - revision procedures where other treatments or devices have failed and if bone reconstruction so permits. • Sunfit TH, Novae® E TH, and Coptos TH acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use. • Hype® SCS, SCC, SCL, SCV, SCC Mini, and SCLA Mini hip stems are intended for press-fit use. The Novae® Dual Mobility and Hype® hip Systems are indicated for total hip replacement, which includes: - osteoarthritis, - femoral neck fracture, - dislocation risk, - osteonecrosis of the femoral head, - revision procedures where other treatments or devices have failed and if bone reconstruction so permits. • Sunfit TH, Novae® E TH, and Coptos TH acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use. • Hype® SCS, SCC, SCL, SCV, SCC Mini, and SCLA Mini hip stems are intended for press-fit use. • Novae® dual mobility acetabular cups are indicated for total hip replacement, which includes: - osteoarthritis, - femoral neck fracture, - dislocation risk, - osteonecrosis of the femoral head, - revision procedures where other treatments or devices have failed and if bone reconstruction so permits. • “Sunfit TH”, “Novae E TH” and “Coptos TH” acetabular cups are intended for press-fit use. • Novae® Stick acetabular cup is intended for cemented use.

Source page: https://510kreport.com/device/K250989
Methodology: https://510kreport.com/methodology