510(k) · Cleared
Recalled · 2004Nexgen Complete Knee Solution Rotatng Hinge Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Jan 9, 2002 as substantially equivalent to K945028 (Biomet, Inc., 1996) after an 89-day review. Its family tree reaches back 1 generation to 1996. 54 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 9, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945028 (1996). 54 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK945028 Finn Knee SystemBiomet, Inc. · 1996
- This deviceK013385 Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc. · 2002
- Descendant · cites it directly · 13 of its ownK070978 Zimmer Segmental SystemZimmer, Inc. · 2007 · Recalled
- Descendant · cites it directly · 11 of its ownK143179 The LINK® Endo-Model® Knee SystemWaldemar Link GmbH & Co. KG · 2015 · Recalled
- Descendant · cites it directly · 11 of its ownK081111 Legion Hinge Knee SystemSmith & Nephew, Inc. · 2008 · Recalled
- Descendant · cites it directly · 10 of its ownK110940 Zimmer Segment System Trabecular Metal Proximal Tibial Component…Zimmer, Inc. · 2011
- Descendant · cites it directly · 10 of its ownK101815 Enduro Knee SystemAesculap Implant Systems · 2010
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K070978Zimmer Segmental SystemZimmer, Inc. · 2007 · cites it directly13descendants
- K143179The LINK® Endo-Model® Knee SystemWaldemar Link GmbH & Co. KG · 2015 · cites it directly11descendants
- K081111Legion Hinge Knee SystemSmith & Nephew, Inc. · 2008 · cites it directly11descendants
- K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…Zimmer, Inc. · 2011 · cites it directly10descendants
- K101815Enduro Knee SystemAesculap Implant Systems · 2010 · cites it directly10descendants
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) | K013385 | Nexgen Complete Knee Solution Rotatng Hinge Knee | Zimmer, Inc. | 2002 | — |
| +1 | K070978 | Zimmer Segmental System | Zimmer, Inc. | 2007 | 6 |
| +1 | K143179 | The LINK® Endo-Model® Knee System | Waldemar Link GmbH & Co. KG | 2015 | 7 |
| +1 | K081111 | Legion Hinge Knee System | Smith & Nephew, Inc. | 2008 | 7 |
| +1 | K110940 | Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular… | Zimmer, Inc. | 2011 | — |
| +1 | K101815 | Enduro Knee System | Aesculap Implant Systems | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 8 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 9 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K945028 | Finn Knee SystemSummary page 1…ng Hinge Knee Total Knee Prosthesis Knee joint femorotibial metal/polymer constrained cemented prosthesis, 21 CFR § 888.3510 Finn Knee System, manufactured by Biomet, K945028, cleared February 14, 1996 The NexGen Rotating Hinge Knee (RHK) is a knee prosthesis that is constrained in the anterior/ poster… | 1996 |
What descends from it? (54)
See all 549 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070978 | Zimmer Segmental System | 2007 | 13 |
| K143179 | The LINK® Endo-Model® Knee System | 2015 | 11 |
| K081111 | Legion Hinge Knee System | 2008 | 11 |
| K110940 | Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal… | 2011 | 10 |
| K101815 | Enduro Knee System | 2010 | 10 |
| K152494 | Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments | 2015 | 6 |
| K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | 2018 | 5 |
| K130299 | GMK Hinge | 2013 | 4 |
| K190100 | USTAR II System | 2019 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2004 | Not classified | Z-1448-04 | Other | The polyethylene tibial bushing was omitted from the taper of the tibial plates. |
| Aug 3, 2004 | Not classified | Z-1447-04 | Other | The polyethylene tibial bushing was omitted from the taper of the tibial plates. |
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?
This device is indicated for moderate to severe knee instability, significant bone loss and/or
ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis,
traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral
condyle, valgus, varus, or flexion deformities and/or for the salvage of previously failed
surgical attempts
This device is intended for cemented use only.
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/K013385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013385: Nexgen Complete Knee Solution Rotatng Hinge Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013385
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026