# K010810: Depuy Preservation Unicondylar Knee Prosthesis

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Apr 18, 2001 after 30 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
99 later devices descend from it; 8 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020741: Unicondylar Knee (2002), 81 descendants of its own
- K022437: Uni Knee (2002), 80 descendants of its own
- K061648: Depuy Graduated Compartmental Knee (GCK) (2006), 61 descendants of its own
- K070849: Depuy GCK Femoral and Tibial Components (2007), 59 descendants of its own
- K080368: Mako Surgical Corp. Unicondylar Knee Implant System II (2008), 56 descendants of its own

## Recalls of this device
- Sep 27, 2007 · Not classified · Z-0433-2008: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- Sep 27, 2007 · Not classified · Z-0430-2008: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- Sep 27, 2007 · Not classified · Z-0428-2008: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- Sep 27, 2007 · Not classified · Z-0429-2008: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- Sep 27, 2007 · Not classified · Z-0431-2008: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- Sep 27, 2007 · Not classified · Z-0432-2008: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1152-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1141-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1151-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1150-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1153-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1146-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1147-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1143-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1142-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1148-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1145-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1149-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1144-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

Source page: https://510kreport.com/device/K010810
Methodology: https://510kreport.com/methodology