# K242315: Resolve Modular Revision Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: May 1, 2025 after 269 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: 9 generations back to P960047 (1997). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090757: Biomet Modular Femoral Revision System, Biomet, Inc. (2009) Summary page 5.
- K022549: Restoration Modular System, Howmedica Osteonics Corp. (2002) Summary page 5.
- K051363: Restoration Modular System, Howmedica Osteonics Corp. (2005) Summary page 5.
- K213129: Restoration Modular 115mm Conical Distal Stem, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2021) Summary page 5.
- K994126: Modular-Plus Revision Stem, Plus Orthopedics (2000) Summary page 5.
- K003237: U2 Hip Stem, TI Porous Coated, United Orthopedic Corp. (2001) Summary page 5.
- K172251: UTS Stem, United Orthopedic Corporation (2017) Summary page 5.
- K050262: U2 Acetabular Component, United Orthopedic Corp. (2005) Summary page 5.
- K110245: United Utf Stem, United Orthopedic Corporation (2011) Summary page 5.
- K183312: Conformity Stem, United Orthopedic Corporation (2019) Summary page 5.

## Indications for use
1. Non-inflammatory degenerative joint disease Including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. This device is a single use implant and intended for cementless use only.

Source page: https://510kreport.com/device/K242315
Methodology: https://510kreport.com/methodology