# K132312: Renovis Tesera Trabecular Technology (T3) Acetabular Shell System

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies, LLC
- Decided: Apr 11, 2014 after 260 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: 8 generations back to K931641 (1994). 93 ancestors in all.
6 later devices descend from it; 5 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)
- K102975: Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole, Exactech, Inc. (2010) Summary page 1.

## Most influential descendants
- K141676: Renovis Surgical Porous Acetabular Cup System (2014), 4 descendants of its own
- K200328: Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System (2020), 1 descendant of its own
- K242045: Initia T3 Acetabular Hemispherical Shell System (2025), 0 descendants 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

## Indications for use
The Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System components are to be used with components of the Renovis A400 Surgical Hip Replacement System, and are indicated for patients suffering from: 1. Non-inflammatory degenerative joint disease including osteoartbritis 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 Tesera Trabecular Technologies (T3) Acetabular Shell System is intended for cementless applications.

Source page: https://510kreport.com/device/K132312
Methodology: https://510kreport.com/methodology