510(k) · Cleared
Recalled · Class II · 2020Oncology Salvage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Nov 24, 2000 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 62 later devices descend from it. It has been recalled 14 times.
- Decided
- Nov 24, 2000
- Review
- 80 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 14
- Predicates
- 0
62 later devices descend from it, 21 citing it directly.
- This deviceK002757 Oncology Salvage SystemBiomet, Inc. · 2000
- Descendant · cites it directly · 19 of its ownK053505 Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc. · 2006
- Descendant · 2 generations on · 13 of its ownK080361 Regenerex Tibial ComponentsBiomet, Inc. · 2008 · Recalled
- Descendant · cites it directly · 12 of its ownK041352 Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004
- Descendant · cites it directly · 11 of its ownK052685 Orthopedic Salvage System- OssBiomet, Inc. · 2005 · Recalled
- Descendant · cites it directly · 11 of its ownK043547 Compress Segmental Femoral Replacement SystemBiomet, Inc. · 2005 · Recalled
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K053505Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc. · 2006 · cites it directly19descendants
- K080361Regenerex Tibial ComponentsBiomet, Inc. · 2008 · 2 generations on13descendants
- K041352Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004 · cites it directly12descendants
- K052685Orthopedic Salvage System- OssBiomet, Inc. · 2005 · cites it directly11descendants
- K043547Compress Segmental Femoral Replacement SystemBiomet, Inc. · 2005 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002757 | Oncology Salvage System | Biomet, Inc. | 2000 | — |
| +1 | K053505 | Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments | Biomet Manufacturing, Inc. | 2006 | — |
| +2 | K080361 | Regenerex Tibial Components | Biomet, Inc. | 2008 | 1 |
| +1 | K041352 | Compress Distal Femoral Replacement System | Biomet, Inc. | 2004 | — |
| +1 | K052685 | Orthopedic Salvage System- Oss | Biomet, Inc. | 2005 | 2 |
| +1 | K043547 | Compress Segmental Femoral Replacement System | Biomet, Inc. | 2005 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (62)
See all 6221 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053505 | Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments | 2006 | 19 |
| K041352 | Compress Distal Femoral Replacement System | 2004 | 12 |
| K052685 | Orthopedic Salvage System- Oss | 2005 | 11 |
| K043547 | Compress Segmental Femoral Replacement System | 2005 | 11 |
| K021260 | Reduced Size Oncology Salvage System | 2002 | 7 |
| K123501 | Oss Modular Stems, Oss Diaphyseal Segments | 2013 | 6 |
| K051479 | RS (Reduced Size) Oss (Orthopedic Salvage System) Additional Components | 2005 | 6 |
| K051570 | Avl Hinge Knee System | 2005 | 4 |
| K141331 | Biomet Orthopaedic Salvage System (Oss) | 2014 | 3 |
| K121029 | Mets Modular Distal Femur | 2012 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2020 | Class II | Z-0623-2021 | Process control | 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 | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit |
| Oct 10, 2018 | Class II | Z-0590-2019 | Under Investigation by firm | 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 Humeral Stem is potentially labeled as… |
| Jun 5, 2017 | Class II | Z-0303-2018 | Labeling False and Misleading | 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 | Mixed-up of materials/components | 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 | Process control | The retaining ring may fall out of the instrument during surgery. |
| May 19, 2009 | Not classified | Z-1530-2009 | Process control | The retaining ring may fall out of the instrument during surgery. |
| May 19, 2009 | Not classified | Z-1527-2009 | Process control | The retaining ring may fall out of the instrument during surgery. |
| May 19, 2009 | Not classified | Z-1529-2009 | Process control | The retaining ring may fall out of the instrument during surgery. |
| May 19, 2009 | Not classified | Z-1531-2009 | Process control | The retaining ring may fall out of the instrument during surgery. |
| May 19, 2009 | Not classified | Z-1526-2009 | Process control | The retaining ring may fall out of the instrument during surgery. |
| May 15, 2008 | Not classified | Z-1881-2008 | Labeling False and Misleading | 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 be incurred while clarifying package… |
| May 15, 2008 | Not classified | Z-1880-2008 | Labeling False and Misleading | 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 be incurred while clarifying package… |
| May 15, 2008 | Not classified | Z-1879-2008 | Labeling False and Misleading | 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 be incurred while clarifying package… |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053505 (Biomet Manufacturing, Inc., 2006) has gone furthest, with 19 descendants of its own.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K002757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002757: Oncology Salvage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002757
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026