# K121308: Hip Systems

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 30, 2012 after 90 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 8 cite it directly.
0 of 22 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
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K213129: Restoration Modular 115mm Conical Distal Stem (2021), 8 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own

## Recalls of this device
- Dec 30, 2021 · Class II · Z-0651-2022: There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
- Dec 30, 2021 · Class II · Z-0652-2022: There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
- Dec 21, 2021 · Class II · Z-0644-2022: There is a potential for the outer Tyvek lid to de-bond from the sealed package.
- Oct 3, 2019 · Class II · Z-0514-2020: Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)
- Jul 21, 2017 · Class II · Z-0940-2018: Inner and outer sterile barriers not fully sealed.
- Jul 21, 2017 · Class II · Z-0941-2018: Inner and outer sterile barriers not fully sealed.
- Sep 8, 2015 · Class II · Z-0261-2016: Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.

## Indications for use
The overall indications for use for the subject total and hemi hip replacement prostheses 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. The Rejuvenate Hip System is intended for cementless use only. Additional indications specific to the Hipstar Stem: The Hipstar Femoral Stem is intended for cementless use only. When mated with a constrained acetabular liner the Hipstar Stem is indicated for use in primary and revision total hip arthroplasty for patients at high risk of hip dislocation due to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Additional indications specific to the Restoration Modular Hip System: 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.

Source page: https://510kreport.com/device/K121308
Methodology: https://510kreport.com/methodology