# K113038: Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 5, 2012 after 85 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962137 (1996). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073175: Journey Unicondylar Femoral Implant, Smith & Nephew, Inc. (2007) Summary page 1.
- K030301: Unicondylar Femoral Component, Smith & Nephew, Inc. (2003) Summary page 1.
- K061569: Smith & Nephew Competitor Deuce Femoral Components, Smith & Nephew, Inc. (2006) Summary page 1.
- K051086: Smith & Nephew Patello-Femoral Implant, Smith & Nephew, Inc. (2005) Summary page 1.
- K912735: Genesis Unicompartmental Knee System, Smith & Nephew Richards, Inc. (1991) Summary page 1.
- K102069: Journey Unicondylar Tibial Baseplates, Smith & Nephew, Inc. (2010) Summary page 1.
- K061011: Competitor Unicondylar Knee Tibial Baseplate, Smith & Nephew, Inc. (2006) Summary page 1.
- K061779: Competitor Unicondylar All-Poly Tibial Baseplate, Smith & Nephew, Inc. (2006) Summary page 1.

## Indications for use
Smith and Nephew Unicondylar Knee Systems are indicated for restoring either compartment of a knee that has been affected by the following: 1. Noninflammatory degenerative joint disease including osteoarhritis, traumatic arthritis, or avascular necrosis; 2. Correction of functional deformity; 3. Revision procedures where other treatments or devices have failed: and 4. Treatment of fractures that are unmanageable using other techniques Smith and Nephew Bicompartmental Knee Systems are intended to be used for those patients whereby conditions exist that cannot be solely addressed by adevice that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee. Indications include: " Post-traumatic arthritis; " Degenerative arthiritis; and * Failed osteotomies, hemniarthroplasties; and unicompartmental replacement These indications will be used for Smith and Nephew Bicompartmental Knee Systems, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions. The Smith and Nephew Patello-Femoral Joint Knee Systems are indicated for replacement of the femoral side of the patello-femoral joint. They are intended to be used in patellofemoral arthoplasty in patients with:I 1. Degenerative arthritis in the distal femur and patella. 2. A history of patellar dislocation or patellar fracture. 3. Failed previous surgery (arthroplasty, tibia[ tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

Source page: https://510kreport.com/device/K113038
Methodology: https://510kreport.com/methodology