510(k) · Cleared
ClearedEnduro Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Dec 20, 2010 as substantially equivalent to K013385 (Zimmer, Inc., 2002) and 1 other predicate after a 173-day review. Its family tree reaches back 5 generations to 1992. 10 later devices descend from it.
- Decided
- Dec 20, 2010
- Review
- 173 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K915192 (1992). 16 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
- 4 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
- 3 generations backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
- 2 generations backK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
- 1 generation backK083772 Columbus Revision Knee SystemAesculap Implant System, Inc. · 2009 · Recalled
- This deviceK101815 Enduro Knee SystemAesculap Implant Systems · 2010
- Descendant · cites it directly · 4 of its ownK130299 GMK HingeMedacta International · 2013 · Recalled
- Descendant · cites it directly · 4 of its ownK120955 Columbus Total Knee System as Columbus Revision Knee System Enduro…Aesculap Implant Systems, LLC · 2012
- Descendant · 2 generations on · 3 of its ownK143443 VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015
- Descendant · cites it directly · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK172347 GMK Hinge, GMK RevisionMedacta International S.A. · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K130299GMK HingeMedacta International · 2013 · cites it directly4descendants
- K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC · 2012 · cites it directly4descendants
- K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015 · 2 generations on3descendants
- K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · cites it directly2descendants
- K172347GMK Hinge, GMK RevisionMedacta International S.A. · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915192 | 7000 Series Modular Tibial Components | Osteonics Corp. | 1992 | — |
| −4 | K994128 | Scorpio Total Stablizer (TS) Total Knee System | Howmedica Osteonics Corp. | 2000 | 8 |
| −3 | K021313 | Search Evolution Total Knee System | Aesculap, Inc. | 2002 | — |
| −2 | K022672 | Columbus Total Knee System (CR) | Aesculap, Inc. | 2002 | 1 |
| −1 | K083772 | Columbus Revision Knee System | Aesculap Implant System, Inc. | 2009 | 4 |
| 0 (this device) | K101815 | Enduro Knee System | Aesculap Implant Systems | 2010 | — |
| +1 | K130299 | GMK Hinge | Medacta International | 2013 | 2 |
| +1 | K120955 | Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System | Aesculap Implant Systems, LLC | 2012 | — |
| +2 | K143443 | VEGA Knee System, Columbus Total Knee System | Aesculap Implants Systems, LLC | 2015 | — |
| +1 | K191765 | OMNI TiN Coated Apex Knee™ System | Omni Life Science, Inc. | 2019 | — |
| +2 | K172347 | GMK Hinge, GMK Revision | Medacta International S.A. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K013385 | Nexgen Complete Knee Solution Rotatng Hinge KneeSummary page 1…ulap Implant Systems, LLC believes that the EnduRo Knee System is substantially equivalent to: " NexGen Complete Knee Solution Rotating Hinge Knee, Zimmer, Inc. (K013385) * Aesculap Implant Systems Columbus REVISION Knee System (K083772) DEVICE DESCRIPTION The EnduRo Knee System is a cement… | 2002 |
| * | K083772 | Columbus Revision Knee SystemSummary page 1…ially equivalent to: " NexGen Complete Knee Solution Rotating Hinge Knee, Zimmer, Inc. (K013385) * Aesculap Implant Systems Columbus REVISION Knee System (K083772) DEVICE DESCRIPTION The EnduRo Knee System is a cemented prosthesis with a rotating hinge design. The femoral component, tibial… | 2009 |
What descends from it? (10)
3 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)
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 5 companies; a new generation was cleared every 2.4 years on median.
- 9 of the 16 ancestors have a recall of any class.
- Of its descendants, K130299 (Medacta International, 2013) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K013385.
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. 2010, 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 EnduRo Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. Hinge knee systems are designed for use in patients in primary or revision surgery, where…
Read the full statement (110 words)
The EnduRo Knee System is indicated for use in reconstruction of the diseased knee joint
caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed
arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients
suffering from correctable valgus or varus deformity and moderate flexion contracture.
Hinge knee systems are designed for use in patients in primary or revision surgery, where the
posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient.
The femoral and tibial augments are to be attached to their respective components with a fixation
screw or screws.
The EnduRo Knee System is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101815: Enduro Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101815
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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