# K190276: Provident II Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Stelkast, Inc.
- Decided: Mar 8, 2019 after 28 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: 5 generations back to K810258 (1981). 13 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935484: Provident Hip System, Stelkast Company (1994) Summary page 6.
- K946371: Provident HP System, Stelkast Company (1995) Summary page 6.
- K001745: Modification to Provident Hip System, Stelkast Company (2000) Summary page 6.
- K002796: Modification to Provident Hip System, Stelkast Company (2000) Summary page 6.
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM, Stelkast Company (2011) Summary page 6.
- K122773: Cross-Over Acetabular Shell & Liner, Stelkast Company (2012) Summary page 6.

## Most influential descendants
- K254043: TRIVANCE™ Hip Stem (2026), 0 descendants of its own
- K201733: Provident II Hip Stems (2021), 0 descendants of its own

## Indications for use
1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, 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. Cemented and Uncemented Applications

Source page: https://510kreport.com/device/K190276
Methodology: https://510kreport.com/methodology