# K143647: Renovis Surgical Hip Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies, Inc.
- Decided: May 11, 2015 after 140 days
- Product code: OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, 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: 8 generations back to K810258 (1981). 71 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112897: Renovis Surgical Hip Joint Replacement Prosthesis, Renovis Surgical Technologies, LLC (2012) Summary page 4.

## Most influential descendants
- K171543: Renovis Surgical Hip Replacement System (2017), 0 descendants of its own

## Indications for use
The Renovis 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 Renovis A400 Hip System is intended for cementless applications unless used with the Renovis Cemented Hip Stem.

Source page: https://510kreport.com/device/K143647
Methodology: https://510kreport.com/methodology