# K172194: Connector System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Aug 18, 2017 after 28 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K040583 (2004). 255 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170647: Connector System, Orthofix, Inc. (2017) Summary page 5.

## Most influential descendants
- K183639: Mariner Outrigger Revision System (2019), 8 descendants of its own
- K193396: PERLA® TL posterior osteosynthesis system (2020), 7 descendants of its own
- K203222: PERLA TL Posterior Osteosynthesis System (2020), 4 descendants of its own
- K203506: PERLA® TL posterior osteosynthesis system (2021), 3 descendants of its own
- K190751: Connector System (2019), 3 descendants of its own

## Recalls of this device
- Feb 23, 2018 · Class II · Z-1363-2018: Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 
- Feb 23, 2018 · Class II · Z-1364-2018: Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 

## Indications for use
When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Thoracic (Occ – T3) The Connector System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Connector System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. When used with the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium) The Connector System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities: 1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) 2. spondylolisthesis, 3. trauma (i.e., fracture or dislocation), 4. spinal stenosis, 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6. tumor, 7. pseudoarthrosis, and 8. failed previous fusion When used for posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.

Source page: https://510kreport.com/device/K172194
Methodology: https://510kreport.com/methodology