# K171543: Renovis Surgical Hip Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies
- Decided: Nov 16, 2017 after 174 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: 10 generations back to K931641 (1994). 97 ancestors in all.
No later device cites it as a predicate yet.
0 of 98 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.
- K141676: Renovis Surgical Porous Acetabular Cup System, Renovis Surgical Technologies, Inc. (2014) Summary page 4.
- K143647: Renovis Surgical Hip Replacement System, Renovis Surgical Technologies, Inc. (2015) Summary page 4.

## 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. The Renovis Surgical Porous Coated Acetabular Shell System is intended for cementless applications. The Cemented Hip Stem is intended for cemented applications. The Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System is intended for cementless applications. The Bipolar Head is for use in conjunction with Renovis femoral heads and femoral stems. Bipolar outer heads are not for use with acetabular shells and liners.

Source page: https://510kreport.com/device/K171543
Methodology: https://510kreport.com/methodology