510(k) · Cleared
Recalled · Class II · 2026Link® Megasystem-C®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldemar Link GmbH & Co. KG · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Aug 26, 2015 as substantially equivalent to K023087 (Howmedica Osteonics Corp., 2002) after a 133-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it. It has been recalled 16 times.
- Decided
- Aug 26, 2015
- Review
- 133 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 16
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023087 (2002). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK023087 Global Modular Replacement System (GMRS)Howmedica Osteonics Corp. · 2002 · Recalled
- This deviceK151008 Link® Megasystem-C®Waldemar Link GmbH & Co. KG · 2015
- Descendant · cites it directly · 0 of its ownK220628 LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG · 2022
- Descendant · cites it directly · 0 of its ownK213675 MP Reconstruction SystemWaldemar Link GmbH & Co. KG · 2022
- Descendant · cites it directly · 0 of its ownK211768 LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG · 2021
- Descendant · cites it directly · 0 of its ownK190181 Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp. · 2019
Most influential descendants
Showing 4 of 4 · See all- K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG · 2022 · cites it directly0descendants
- K213675MP Reconstruction SystemWaldemar Link GmbH & Co. KG · 2022 · cites it directly0descendants
- K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG · 2021 · cites it directly0descendants
- K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023087 | Global Modular Replacement System (GMRS) | Howmedica Osteonics Corp. | 2002 | 2 |
| 0 (this device) | K151008 | Link® Megasystem-C® | Waldemar Link GmbH & Co. KG | 2015 | — |
| +1 | K220628 | LINK Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 2022 | — |
| +1 | K213675 | MP Reconstruction System | Waldemar Link GmbH & Co. KG | 2022 | — |
| +1 | K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | Waldemar Link GmbH & Co. KG | 2021 | — |
| +1 | K190181 | Instruments for LINK MEGASYSTEM-C Family | LinkBio Corp. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K023087 | Global Modular Replacement System (GMRS)Summary page 5…cation and Panel: Class II, Orthopedic / 87 Predicate Devices: GMRSTM Global Modular Replacement System, manufactured by Stryker, K023087, cleared December 16, 2002 Device Description: The LINK® MEGASYSTEM-C® is comprised of a number… | 2002 |
What descends from it? (4)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 12, 2026 | Class II | Z-1521-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Jan 12, 2026 | Class II | Z-1517-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Jan 12, 2026 | Class II | Z-1522-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Jan 12, 2026 | Class II | Z-1514-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Jan 12, 2026 | Class II | Z-1519-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Jan 12, 2026 | Class II | Z-1516-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Jan 12, 2026 | Class II | Z-1513-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Jan 12, 2026 | Class II | Z-1511-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Jan 12, 2026 | Class II | Z-1520-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Jan 12, 2026 | Class II | Z-1512-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Jan 12, 2026 | Class II | Z-1515-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Jan 12, 2026 | Class II | Z-1518-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Jan 12, 2026 | Class II | Z-1523-2026 | Under Investigation by firm | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. |
| Nov 10, 2025 | Class II | Z-0890-2026 | Process control | The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component. |
| May 22, 2024 | Class II | Z-2410-2024 | Process design | Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique |
| May 22, 2024 | Class II | Z-2411-2024 | Process design | Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique |
The 5 latest of 16 recalls; the web page lists all.
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. 2015, 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 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…
Read the full statement (218 words)
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 after primary total knee replacement.
4) Revision surgery after hinge knee or rotational knee joint.
5) Revision surgery by insufficient / inadequate bone mass.
6) Arthrosis of patella flange.
7) Valgus/Varus deformities <10°.
8) Valgus/Varus deformities 10-15°.
9) Valgus/Varus 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 collateral ligaments and muscular instability.
11) Valgus/Varus 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/K151008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151008: Link® Megasystem-C®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151008
Report an extraction error
Are you the manufacturer?
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