# K040268: Depuy Preservation Unicondylar Tibia

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: May 5, 2004 after 90 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954481 (1996). 2 ancestors in all.
47 later devices descend from it; 4 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010810: Depuy Preservation Unicondylar Knee Prosthesis, DePuy Orthopaedics, Inc. (2001) Summary page 1.
- K954481: P.F.C. Uni-Compartmental Knee System, Johnson & Johnson Professionals, Inc. (1996) Summary page 1.

## Most influential descendants
- K063432: Conformis Metal Backed Tibial Component (MBT) (2007), 32 descendants of its own
- K072368: Conformis Metal Backed Tibial Component (2007), 31 descendants of its own
- K092441: Modification to: Conformis Iuni Unicondylar Knee Repair System (2009), 29 descendants of its own
- K111916: Conformis Iuni Unicondylar Knee Replacement System (2011), 28 descendants of its own
- K121974: Conformis Iuni Unicondylar Knee Replacement System (2012), 27 descendants of its own

## Recalls of this device
- Nov 15, 2006 · Not classified · Z-0456-2007: Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Nov 15, 2006 · Not classified · Z-0457-2007: Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Nov 15, 2006 · Not classified · Z-0458-2007: Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Nov 15, 2006 · Not classified · Z-0459-2007: Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Nov 15, 2006 · Not classified · Z-0465-2007: Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Nov 15, 2006 · Not classified · Z-0460-2007: Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Nov 15, 2006 · Not classified · Z-0461-2007: Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Nov 15, 2006 · Not classified · Z-0462-2007: Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Nov 15, 2006 · Not classified · Z-0463-2007: Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Nov 15, 2006 · Not classified · Z-0464-2007: Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.

## Indications for use
The DePuy PreservationTM Unicondylar Knee is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Caution: This knee prosthesis component is intended for cemented use only. Candidates for unicondylar knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. In candidates for unicondylar knee arthroplasty, only one side of the joint (the medial or lateral compartmental) is affected. Unicondylar knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives.

Source page: https://510kreport.com/device/K040268
Methodology: https://510kreport.com/methodology