510(k) · Cleared
ClearedInstruments for LINK MEGASYSTEM-C Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LinkBio Corp. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Oct 25, 2019 as substantially equivalent to K151008 (Waldemar Link GmbH & Co. KG, 2015) and 2 other predicates after a 266-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Oct 25, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K945028 (1996). 7 ancestors in all, the oldest K955296 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 2 generations backK013385 Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc. · 2002 · Recalled
- 1 generation backK143179 The LINK® Endo-Model® Knee SystemWaldemar Link GmbH & Co. KG · 2015 · Recalled
- This deviceK190181 Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −2 | K013385 | Nexgen Complete Knee Solution Rotatng Hinge Knee | Zimmer, Inc. | 2002 | 2 |
| −1 | K143179 | The LINK® Endo-Model® Knee System | Waldemar Link GmbH & Co. KG | 2015 | 7 |
| 0 (this device) | K190181 | Instruments for LINK MEGASYSTEM-C Family | LinkBio Corp. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 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? (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 |
|---|---|---|---|
| * | K151008 | Link® Megasystem-C®Summary page 3…-C® Family Indications for Use (Describe) The Instruments for LINK MEGASYSTEM-C Family are intended to aid in intra-operative implantation of the LINK® MEGASYSTEM-C® (K151008), which can be integrated with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee Sy… | 2015 |
| * | K143179 | The LINK® Endo-Model® Knee SystemSummary page 3…the LINK® MEGASYSTEM-C® (K151008), which can be integrated with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) for knee replacement, and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement. The LINK® MEGASYSTEM-C® (K15100… | 2015 |
| * | K142187 | Link MP Reconstruction ProsthesisSummary page 3…nts of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) for knee replacement, and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement. The LINK® MEGASYSTEM-C® (K151008), has the following indications: The LINK® MEGASYSTEM-C® is intended to be… | 2014 |
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 23 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 6 of the 7 ancestors have a recall of any class.
- 3 other devices also cite its predicate K151008.
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. 2019, 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 Instruments for LINK MEGASYSTEM-C Family are intended to aid in intra-operative implantation of the LINK® MEGASYSTEM-C® (K151008), which can be integrated with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) for knee replacement, and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement. The LINK® MEGASYSTEM-C® (K151008), has the following indications: The LINK®…
Read the full statement (280 words)
The Instruments for LINK MEGASYSTEM-C Family are intended to aid in intra-operative implantation of the LINK® MEGASYSTEM-C® (K151008), which can be integrated with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) for knee replacement, and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement. The LINK® MEGASYSTEM-C® (K151008), has the following indications:
The LINK® MEGASYSTEM-C® is intended to be used with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) which can be integrated for knee joint replacement and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement.
The LINK MEGASYSTEM-C® is indicated for treatment of any of the following Limb salvage/Oncology procedures:
1) Revision for loosened femoral prosthesis components involving extensive bone loss;
2) Surgical intervention for severe trauma;
3) Oncology cases where extensive resection and replacement of bone is required from tibia to hip area;
The device is to be used with bone cement unless a proximal femur or a modular stem is indicated for use.
For the use of the LINK® Endo-Model® SL® Rotating and Non-Rotating Hinge Knee System additional indications should be noted:
1) Bone necroses.
2) Bicondylar arthrosis by partly damaged collateral ligaments.
3) Revision surgery after primary total knee replacement.
4) Revision surgery after rotating or non-rotating hinged knee replacement.
5) Revision surgery by insufficient / inadequate bone mass.
6) Arthrosis of patella flange.
7) ValgusNarus deformities <10°.
8) ValgusNarus deformities 10-15°.
9) ValgusNarus deformities 15-20°.
For the use of the LINK® Endo-Model® SL® Non-Rotating Hinge Knee System additional indications should be noted:
10) Bicondylar arthrosis by completely damaged ligaments and muscular instability.
11) ValgusNarus deformities 20-30°.
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/K190181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190181: Instruments for LINK MEGASYSTEM-C Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190181
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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