# K141370: Renovis Cemented Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies, Inc.
- Decided: Sep 2, 2014 after 98 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963509 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970351: Global Taper Spectron Hip Stems, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 4.
- K963509: Global Taper Tapered Hip System, GT Spectron, Smith & Nephew Richards, Inc. (1997) Summary page 4.

## Indications for use
The Renovis A400 Surgical Hip Replacement System is indicated for patients suffering from: 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; and 5. Revision procedures where other treatment or devices have failed. The Cemented Hip Stem is intended for cemented applications.

Source page: https://510kreport.com/device/K141370
Methodology: https://510kreport.com/methodology