510(k) · Cleared
Recalled · Class II · 2017Expandable Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on May 6, 2002 as substantially equivalent to K945028 (Biomet, Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- May 6, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945028 (1996). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK945028 Finn Knee SystemBiomet, Inc. · 1996
- This deviceK020381 Expandable KneeBiomet Orthopedics, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK140509 Biomet Side Access Distal Femoral ExpandableBiomet Manufacturing, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK152621 OSS/Arcos IM Total Femur RodBiomet, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK122015 Distal Femoral Growing Prosthesis, Tibial Rotating Components…Howmedica Osteonics Corp. · 2013
Most influential descendants
Showing 3 of 3 · See all- K140509Biomet Side Access Distal Femoral ExpandableBiomet Manufacturing, LLC · 2014 · cites it directly1descendant
- K152621OSS/Arcos IM Total Femur RodBiomet, Inc. · 2015 · 2 generations on0descendants
- K122015Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip…Howmedica Osteonics Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| 0 (this device) | K020381 | Expandable Knee | Biomet Orthopedics, Inc. | 2002 | — |
| +1 | K140509 | Biomet Side Access Distal Femoral Expandable | Biomet Manufacturing, LLC | 2014 | — |
| +2 | K152621 | OSS/Arcos IM Total Femur Rod | Biomet, Inc. | 2015 | — |
| +1 | K122015 | Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis… | Howmedica Osteonics Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KRO? 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 KRO device
- #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K945028 | Finn Knee SystemSummary page 1…mented, metal/polymer (888.3510) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Substantial equivalence is claimed to Biomet's Finn® Knee System (K945028) and Oncology Salvage System (K002757). Device Description: The Expandable Knee is an additional component to Biomet's Oncology… | 1996 |
| * | K002757 | Oncology Salvage SystemSummary page 1…lly Marketed Devices To Which Substantial Equivalence Is Claimed: Substantial equivalence is claimed to Biomet's Finn® Knee System (K945028) and Oncology Salvage System (K002757). Device Description: The Expandable Knee is an additional component to Biomet's Oncology Salvage System that gives the surgeon… | 2000 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2017 | Class II | Z-0304-2018 | 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. |
| Jun 5, 2017 | Class II | Z-0305-2018 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 2025
MAUDE reports naming product code KRO, 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 | 1 | — | 1 | 37 |
| 2008 | 3 | 126 | 3 | 44 |
| 2009 | 3 | 86 | 8 | 66 |
| 2010 | 1 | — | 0 | 110 |
| 2011 | 2 | — | 1 | 119 |
| 2012 | 2 | — | 1 | 173 |
| 2013 | 3 | 189 | 2 | 194 |
| 2014 | 2 | — | 0 | 406 |
| 2015 | 6 | 113 | 1 | 333 |
| 2016 | 3 | 148 | 5 | 369 |
| 2017 | 1 | — | 4 | 543 |
| 2018 | 0 | — | 1 | 614 |
| 2019 | 3 | 244 | 0 | 759 |
| 2020 | 1 | — | 0 | 749 |
| 2021 | 3 | 57 | 1 | 770 |
| 2022 | 1 | — | 0 | 892 |
| 2023 | 4 | 148 | 0 | 746 |
| 2024 | 3 | 87 | 0 | 855 |
| 2025 | 3 | 56 | 1 | 915 |
| 2026 | 1 | — | 14 | — |
What is it indicated for?
The Expandable Knee offers a treatment option for patients requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; rheumatoid arthritis; correction of deformity; and correction or revision of unsuccessful osteotomy, arthrodesis or previous joint replacement.
The devices are single use implants intended for implantation with bone cement.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020381: Expandable Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020381
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026