# K112897: Renovis Surgical Hip Joint Replacement Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Renovis Surgical Technologies, LLC
- Decided: Jun 13, 2012 after 254 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: 7 generations back to K810258 (1981). 70 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030055: Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components, Biomet, Inc. (2003) Summary page 2.
- K032396: Ringloc 36MM Line and Modular Femoral Heads, Biomet, Inc. (2003) Summary page 2.
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads, Biomet, Inc. (2005) Summary page 2.
- K061312: 36MM Biolox Delta Ceramic Heads, Biomet, Inc. (2006) Summary page 2.
- K070364: 100KGY E-Poly Maxrom Acetabular Liners, Biomet, Inc. (2007) Summary page 2.
- K073102: Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners, Biomet Manufacturing Corp (2007) Summary page 2.
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712, Encore Medical L.P. (2010) Summary page 3.
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM, Stelkast Company (2011) Summary page 3.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 3.
- K093235: Ringloc + Hybrid Acetabular System, Biomet, Inc. (2010) Summary page 3.
- K981211: Apr -T Revision Hip Stem, Sulzer Orthopedics, Inc. (1998) Summary page 3.

## Most influential descendants
- K132312: Renovis Tesera Trabecular Technology (T3) Acetabular Shell System (2014), 6 descendants of its own
- 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
- K143647: Renovis Surgical Hip Replacement System (2015), 1 descendant of its own
- K242045: Initia T3 Acetabular Hemispherical Shell System (2025), 0 descendants of its own

## Indications for use
The Renovis A400 Surgical Hip Joint Replacement Prosthesis is indicated for patients suffering from the following: 1. Noninflammatory 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 Surgical Hip Joint Replacement Prosthesis is intended for cementless applications.

Source page: https://510kreport.com/device/K112897
Methodology: https://510kreport.com/methodology