510(k) · Cleared
ClearedModula Options for Severe Bone Loss and Trauma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermedics Orthopedics · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jan 16, 1997 after a 77-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Jan 16, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK964350 Modula Options for Severe Bone Loss and TraumaIntermedics Orthopedics · 1997
- Descendant · cites it directly · 10 of its ownK110940 Zimmer Segment System Trabecular Metal Proximal Tibial Component…Zimmer, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK141331 Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK190100 USTAR II SystemUnited Orthopedic Corporation · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK183136 Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK142814 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral &…Biomet Manufacturing, LLC · 2015 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…Zimmer, Inc. · 2011 · cites it directly10descendants
- K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014 · 2 generations on3descendants
- K190100USTAR II SystemUnited Orthopedic Corporation · 2019 · 2 generations on2descendants
- K183136Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc. · 2019 · 2 generations on1descendant
- K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964350 | Modula Options for Severe Bone Loss and Trauma | Intermedics Orthopedics | 1997 | — |
| +1 | K110940 | Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular… | Zimmer, Inc. | 2011 | — |
| +2 | K141331 | Biomet Orthopaedic Salvage System (Oss) | Biomet, Inc. | 2014 | — |
| +2 | K190100 | USTAR II System | United Orthopedic Corporation | 2019 | 5 |
| +2 | K183136 | Zimmer Segmental System Proximal Femoral Component | Zimmer, Inc. | 2019 | — |
| +3 | K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Biomet Manufacturing, LLC | 2015 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | — | Segmented Oncology System (S.O.S.™) Proximal Femur Named without a submission number | |
| * | — | MP Reconstruction Prosthesis Named without a submission number | |
| * | — | Noiles Total Knee Prosthesis Named without a submission number | |
| * | — | Kinematic II Rotating Hinge Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110940 | Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal… | 2011 | 10 |
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?
- Of its descendants, K110940 (Zimmer, Inc., 2011) has gone furthest, with 10 descendants of its own.
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.
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 to replace the proximal, distal or total femur, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary. Proximal replacement components are available for press-fit or cemented application. Components used for replacement of the distal femur are for cemented use only. Specific…
Read the full statement (131 words)
This device is intended to replace the proximal, distal or total femur, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary. Proximal replacement components are available for press-fit or cemented application. Components used for replacement of the distal femur are for cemented use only. Specific diagnostic indications for use of the MOST include:
metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
revision cases requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur; and,
severe conditions of inflammatory or noninflammatory degenerative joint disease that require extensive resection(s) and replacement(s) of the proximal and/or distal femur.
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/K964350 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964350: Modula Options for Severe Bone Loss and Trauma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964350
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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