# K002757: Oncology Salvage System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Nov 24, 2000 after 80 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
62 later devices descend from it; 21 cite it directly.
0 of 63 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
- K053505: Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments (2006), 19 descendants of its own
- K080361: Regenerex Tibial Components (2008), 13 descendants of its own
- K041352: Compress Distal Femoral Replacement System (2004), 12 descendants of its own
- K052685: Orthopedic Salvage System- Oss (2005), 11 descendants of its own
- K043547: Compress Segmental Femoral Replacement System (2005), 11 descendants of its own

## Recalls of this device
- Nov 25, 2020 · Class II · Z-0623-2021: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
- Apr 17, 2020 · Class II · Z-2147-2020: Potential presence of elevated endotoxin levels that exceed the specification limit
- Oct 10, 2018 · Class II · Z-0590-2019: Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini H
- Jun 5, 2017 · Class II · Z-0303-2018: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
- Nov 1, 2011 · Not classified · Z-0417-2012: Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14x150).
- May 19, 2009 · Not classified · Z-1528-2009: The retaining ring may fall out of the instrument during surgery.
- May 19, 2009 · Not classified · Z-1530-2009: The retaining ring may fall out of the instrument during surgery.
- May 19, 2009 · Not classified · Z-1527-2009: The retaining ring may fall out of the instrument during surgery.
- May 19, 2009 · Not classified · Z-1529-2009: The retaining ring may fall out of the instrument during surgery.
- May 19, 2009 · Not classified · Z-1531-2009: The retaining ring may fall out of the instrument during surgery.
- May 19, 2009 · Not classified · Z-1526-2009: The retaining ring may fall out of the instrument during surgery.
- May 15, 2008 · Not classified · Z-1881-2008: Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may 
- May 15, 2008 · Not classified · Z-1880-2008: Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may 
- May 15, 2008 · Not classified · Z-1879-2008: Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may 

Source page: https://510kreport.com/device/K002757
Methodology: https://510kreport.com/methodology