# K964350: Modula Options for Severe Bone Loss and Trauma

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Jan 16, 1997 after 77 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Segmented Oncology System (S.O.S.™) Proximal Femur: named in the summary without a submission number
- (no number) MP Reconstruction Prosthesis: named in the summary without a submission number
- (no number) Noiles Total Knee Prosthesis: named in the summary without a submission number
- (no number) Kinematic II Rotating Hinge: named in the summary without a submission number

## Most influential descendants
- K110940: Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen (2011), 10 descendants of its own
- K141331: Biomet Orthopaedic Salvage System (Oss) (2014), 3 descendants of its own
- K190100: USTAR II System (2019), 2 descendants of its own
- K183136: Zimmer Segmental System Proximal Femoral Component (2019), 1 descendant of its own
- K142814: Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial (2015), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K964350
Methodology: https://510kreport.com/methodology