# K141676: Renovis Surgical Porous Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies, Inc.
- Decided: Nov 4, 2014 after 134 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: 9 generations back to K931641 (1994). 95 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 100 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.
- K132312: Renovis Tesera Trabecular Technology (T3) Acetabular Shell System, Renovis Surgical Technologies, LLC (2014) Summary page 4.
- K974093: Foundation Porous Coated Hemispherical Shell, Encore Orthopedics, Inc. (1998) Summary page 4.

## Most influential descendants
- K200328: Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System (2020), 1 descendant of its own
- K203472: KMTI Hip Replacement System (2021), 0 descendants of its own
- K201660: KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System (2020), 0 descendants of its own
- 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.

Source page: https://510kreport.com/device/K141676
Methodology: https://510kreport.com/methodology