510(k) · Cleared
Recalled · Class II · 2024Global Modular Replacement System (GMRS)
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 Dec 16, 2002 after a 90-day review. The FDA summary names its predicate without a number. 29 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 16, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 2
- Predicates
- 0
29 later devices descend from it, 12 citing it directly.
- This deviceK023087 Global Modular Replacement System (GMRS)Howmedica Osteonics Corp. · 2002
- Descendant · cites it directly · 7 of its ownK092138 JTS Extendeable ImplantStanmore Implants Worldwide, Ltd. · 2011 · Recalled
- Descendant · cites it directly · 5 of its ownK222056 Global Modular Replacement System, Modular Replacement System…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · Recalled
- Descendant · cites it directly · 4 of its ownK151008 Link® Megasystem-C®Waldemar Link GmbH & Co. KG · 2015 · Recalled
- Descendant · cites it directly · 3 of its ownK181778 MUTARS Proximal Femur Replacement SystemImplantcast GmbH · 2019
- Descendant · cites it directly · 3 of its ownK121029 Mets Modular Distal FemurStanmore Implants Worldwide, Ltd. · 2012
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K092138JTS Extendeable ImplantStanmore Implants Worldwide, Ltd. · 2011 · cites it directly7descendants
- K222056Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · cites it directly5descendants
- K151008Link® Megasystem-C®Waldemar Link GmbH & Co. KG · 2015 · cites it directly4descendants
- K181778MUTARS Proximal Femur Replacement SystemImplantcast GmbH · 2019 · cites it directly3descendants
- K121029Mets Modular Distal FemurStanmore Implants Worldwide, Ltd. · 2012 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023087 | Global Modular Replacement System (GMRS) | Howmedica Osteonics Corp. | 2002 | — |
| +1 | K092138 | JTS Extendeable Implant | Stanmore Implants Worldwide, Ltd. | 2011 | 1 |
| +1 | K222056 | Global Modular Replacement System, Modular Replacement System, Modular… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | 1 |
| +1 | K151008 | Link® Megasystem-C® | Waldemar Link GmbH & Co. KG | 2015 | 16 |
| +1 | K181778 | MUTARS Proximal Femur Replacement System | Implantcast GmbH | 2019 | — |
| +1 | K121029 | Mets Modular Distal Femur | Stanmore Implants Worldwide, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | — | Modular Replacement System Named without a submission number | |
| * | — | Distal Stems of the Restoration Hip System Named without a submission number | |
| * | — | Modular Rotating Hinge Knee System Named without a submission number | |
| * | — | Kinematic Rotating Hinge Knee System Named without a submission number | |
| * | — | MOST System Named without a submission number |
What descends from it? (29)
See all 2912 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092138 | JTS Extendeable Implant | 2011 | 7 |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | 2023 | 5 |
| K151008 | Link® Megasystem-C® | 2015 | 4 |
| K181778 | MUTARS Proximal Femur Replacement System | 2019 | 3 |
| K121029 | Mets Modular Distal Femur | 2012 | 3 |
| K121055 | Mets Modular Total Femur | 2012 | 3 |
| K033959 | LPS | 2004 | 3 |
| K251665 | Triathlon® Hinge Knee System | 2025 | 2 |
| K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | 2025 | 0 |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge… | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2024 | Class II | Z-2732-2024 | Process control | A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal. |
| May 5, 2005 | Not classified | Z-2624-2010 | Labeling mix-ups | Mislabeled package: Package labeled as GMRS Extension Piece 60 mm, lot ZYCOC1 actually contains a GMRS Extension Piece 70 mm extension piece. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092138 (Stanmore Implants Worldwide, Ltd., 2011) has gone furthest, with 7 descendants of its own.
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?
The Global Modular Replacement System (herein referred to as the GMRS) is intended to be used with the components of Howmedica Osteonics' Modular Replacement System, Modular Rotating Hinge Knee System, and/or Kinematic Rotating Hinge Knee System in situations where replacement of extensive bone loss in the femur and/or proximal tibia is required. The Proximal Femoral Module and Distal Femoral Module of the GMRS may be used together, or with the…
Read the full statement (142 words)
The Global Modular Replacement System (herein referred to as the GMRS) is intended to be used with the components of Howmedica Osteonics' Modular Replacement System, Modular Rotating Hinge Knee System, and/or Kinematic Rotating Hinge Knee System in situations where replacement of extensive bone loss in the femur and/or proximal tibia is required. The Proximal Femoral Module and Distal Femoral Module of the GMRS may be used together, or with the components of the MRS, in replacement of the total femur. Indications and contraindications for this type of replacement are listed below:
Femoral and/or proximal tibial replacement and total femoral replacement in Omology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023087 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023087: Global Modular Replacement System (GMRS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023087
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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