# K955848: Orthofix Modulsystem

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Mar 20, 1996 after 84 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831576 (1983). 1 ancestor in all.
95 later devices descend from it; 14 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831576: Orthofix, Electro-Biology, Inc. (1983) Summary page 2.

## Most influential descendants
- K010322: Iskd (Intramedullary Skeletal Kinetic Distractor) (2001), 35 descendants of its own
- K141078: Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) (2014), 32 descendants of its own
- K031219: Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) (2003), 30 descendants of its own
- K101997: Ellipse Intramedullary Limb Lengthening System (2011), 29 descendants of its own
- K143125: Orthofix True Lok Hexapod System VI.3 (2014), 26 descendants of its own

## Recalls of this device
- Sep 27, 2018 · Class II · Z-0373-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0380-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0382-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0383-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0384-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0385-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0386-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0387-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0389-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0390-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0392-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0374-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0375-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0376-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0377-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0378-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0379-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0381-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0388-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0391-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Sep 27, 2018 · Class II · Z-0393-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo
- Feb 22, 2010 · Not classified · Z-1434-2010: During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.
- Feb 22, 2010 · Not classified · Z-1435-2010: During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.

## Indications for use
This product is a unilateral external fixation device, which is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

Source page: https://510kreport.com/device/K955848
Methodology: https://510kreport.com/methodology