510(k) · Cleared
ClearedDistal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip, Wedge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Feb 22, 2013 as substantially equivalent to K020381 (Biomet Orthopedics, Inc., 2002) and 2 other predicates after a 227-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Feb 22, 2013
- Review
- 227 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K945028 (1996). 5 ancestors in all. No later device cites it as a predicate yet.
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) | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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? (3)
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…Mahwah, NJ 07430 Phone: (20) 831-6365; Fax (201)831-3365 Legally Marketed Devices to Which K0203 81: Expandable Knee Substantial Equivalence Is Claimed: K023087: Global Modular Replacement System… | 2002 |
| * | K023087 | Global Modular Replacement System (GMRS)Summary page 1…Phone: (20) 831-6365; Fax (201)831-3365 Legally Marketed Devices to Which K0203 81: Expandable Knee Substantial Equivalence Is Claimed: K023087: Global Modular Replacement System (GMRS) K965 164: H… | 2002 |
| * | K965164 | Howmedica Modular Replacement System-Proximal FemurSummary page 1…Knee Substantial Equivalence Is Claimed: K023087: Global Modular Replacement System (GMRS) K965 164: Howmedica Modular Replacement System-Proximal Femur Date Prepared:… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 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. 2013, 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 Distal Femoral Growing Prosthesis is indicated for pediatric patients who have not achieved full skeletal maturity (open epiphysis), where radical resection and replacement of the distal femur and or/proximal tibia is required with the following conditions: * Oncology indications * Severe trauma * Noninflammatory degenerative joint disease including osteoarthritis * Correction of functional deformity * Rheumatoid arthritis * Revision procedures where…
Read the full statement (109 words)
The Distal Femoral Growing Prosthesis is indicated for pediatric patients who have not achieved full skeletal maturity (open epiphysis), where radical resection and replacement of the distal femur and or/proximal tibia is required with the following conditions:
* Oncology indications
* Severe trauma
* Noninflammatory degenerative joint disease including osteoarthritis
* Correction of functional deformity
* Rheumatoid arthritis
* Revision procedures where other treatments or devices have failed
The devices are single use implants intended only for implantation with bone cement.
Compatible components of the GMRS, MRH, MRS, and KRH when used with the Distal Femoral Growing Prosthesis are intended for use in pediatric patients for the above-mentioned indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122015: Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip, Wedge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122015
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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