510(k) · Cleared
Recalled · Class II · 2024Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp., Dba Stryker Orthopaedics · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jan 26, 2023 as substantially equivalent to K023087 (Howmedica Osteonics Corp., 2002) after a 198-day review. Its family tree reaches back 1 generation to 2002. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 26, 2023
- Review
- 198 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023087 (2002). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK023087 Global Modular Replacement System (GMRS)Howmedica Osteonics Corp. · 2002 · Recalled
- This deviceK222056 Global Modular Replacement System, Modular Replacement System…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · cites it directly · 2 of its ownK251665 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- Descendant · cites it directly · 1 of its ownK233261 Global Modular Replacement SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2023
- Descendant · 2 generations on · 0 of its ownK261898 Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total…Howmedica Osteonics Corp. dba Stryker Orthopaedics · 2026
- Descendant · 2 generations on · 0 of its ownK252898 Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium®…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK241716 Global Modular Replacement System, Modular Replacement System…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
Most influential descendants
Showing 5 of 5 · See all- K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · cites it directly2descendants
- K233261Global Modular Replacement SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2023 · cites it directly1descendant
- K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics · 2026 · 2 generations on0descendants
- K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 2 generations on0descendants
- K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024 · 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) | K222056 | Global Modular Replacement System, Modular Replacement System, Modular… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +1 | K251665 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +1 | K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2023 | — |
| +2 | K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 2026 | — |
| +2 | K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | 1 |
| +1 | K241716 | Global Modular Replacement System, Modular Replacement System, Modular… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 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 4…er (if known) K222056 Device Name Global Modular Replacement System Indications for Use (Describe) Indications for the Global Modular Replacement System (presented in K023087): • Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and repla… | 2002 |
| † | K952970 | Howmedica Femoral & Proximal Tibial Modular Replacement Sytesm | 1996 |
| † | K022403 | GMRS Press Fit Stems with Purefix HA | 2002 |
| † | K031217 | GMRS Press Fit Stems with Purefix HA | 2003 |
| † | K032581 | Global Modular Replacement System Anteverted Promimal Femoral Component | 2003 |
| † | K040749 | Modular Replacement System Cemented Stems | 2004 |
| † | K002552 | Howmedica Osteonics Modular Rotating Hinge Knee | 2000 |
What descends from it? (5)
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)
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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone…
Read the full statement (327 words)
This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.
The Intercalary System is intended for use in situations arising from in femoral mid-shaft tumor resection, or for prosthetic knee fusion.
Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.
Proximal femoral reconstruction secondary to:
Trauma
Failed previous prosthesis
Tumor resection
Femoral replacement in Oncology 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. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement.
Femoral and/or proximal tibial replacement due to:
Trauma
Failed previous prosthesis
Tumor resection
The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where there is destruction of the joint surfaces, with or without significant bone deformity; the cruciate and/or collateral ligaments do not stabilize the knee joint; the ligaments are inadequate and/or the musculature is weak; and revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue.
Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222056: Global Modular Replacement System, Modular Replacement System, Modular Rotating 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/K222056
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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