# K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 26, 2010 after 90 days
- Product code: MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous)
- 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: 4 generations back to K955033 (1996). 44 ancestors in all.
16 later devices descend from it; 7 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022902: Smith & Nephew Hip System, Smith & Nephew, Inc. (2002) Summary page 1.
- K022958: Total Hip Femoral Heads and Liners, Smith & Nephew, Inc. (2002) Summary page 1.
- K896580: Uni-Polar Head, Richards Medical Co., Inc. (1990) Summary page 1.
- K934353: Zirconium Alloy Uni-Polar Head, Smith & Nephew Richards, Inc. (1994) Summary page 1.
- K062408: Smith & Nephew Modular Femoral (Hemi) Head, Smith & Nephew, Inc. (2006) Summary page 1.
- K061253: Reflection 3 Acetabular System, Smith & Nephew, Inc. (2006) Summary page 1.
- K070756: Smith and Nephew Reflection 3 Acetabular System, Smith & Nephew, Inc. (2007) Summary page 1.
- K071160: Reflection, Tandem Unipolar, Smith & Nephew, Inc. (2007) Summary page 1.
- K061434: Trident Large Diameter Hip System, Howmedica Osteonics Corp. (2006) Summary page 1.
- K062148: Depuy Pinnacle Altrx Acetabular Cup Liner, DePuy Orthopaedics, Inc. (2006) Summary page 1.

## Most influential descendants
- K113848: R3 Xlpe Liners (2012), 7 descendants of its own
- K161233: OXINIUM DH Fermoral Heads (2016), 6 descendants of its own
- K102370: R3 Xlpe Anteverted Liners (2011), 6 descendants of its own
- K191002: OR3O Dual Mobility System (2019), 5 descendants of its own
- K182535: R3 Anteverted Liners (2018), 4 descendants of its own

## Indications for use
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthiritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Source page: https://510kreport.com/device/K093363
Methodology: https://510kreport.com/methodology