510(k) · Cleared
ClearedBiomet Side Access Distal Femoral Expandable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, LLC · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on May 28, 2014 as substantially equivalent to K020381 (Biomet Orthopedics, Inc., 2002) after an 89-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- May 28, 2014
- Review
- 89 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945028 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 1 generation backK020381 Expandable KneeBiomet Orthopedics, Inc. · 2002 · Recalled
- This deviceK140509 Biomet Side Access Distal Femoral ExpandableBiomet Manufacturing, LLC · 2014
- Descendant · cites it directly · 0 of its ownK152621 OSS/Arcos IM Total Femur RodBiomet, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K152621OSS/Arcos IM Total Femur RodBiomet, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −1 | K020381 | Expandable Knee | Biomet Orthopedics, Inc. | 2002 | 2 |
| 0 (this device) | K140509 | Biomet Side Access Distal Femoral Expandable | Biomet Manufacturing, LLC | 2014 | — |
| +1 | K152621 | OSS/Arcos IM Total Femur Rod | Biomet, Inc. | 2015 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K020381 | Expandable KneeSummary page 1…ification panel Orthopedic Product Code(s) KRO HXX( Legally marketed device(s) Biomet Expandable Knee (Biomet Manufacturing), K020381 to which Equivalence is claimed Mailing Address: Shipping Address: P.O.Bo 587 56 E.xi BellD..~ Warssw. IN46… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152621 | OSS/Arcos IM Total Femur Rod | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 12.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K152621 (Biomet, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K020381.
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. 2014, this device’s year, is highlighted.
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 Biomet Side Access Distal Femoral Expandable 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 or with Biomet Compress®.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140509: Biomet Side Access Distal Femoral Expandable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140509
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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