# K121649: Construx Mini Peek TI Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix
- Decided: Nov 29, 2012 after 177 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K003155 (2001). 76 ancestors in all.
289 later devices descend from it; 3 cite it directly.
0 of 366 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101812: Construx Mini Peek Spacer System, Orthofix, Inc. (2010) Summary page 1.
- K100889: Endoskeleton TC, Titan Spine, LLC (2010) Summary page 1.

## Most influential descendants
- K142152: Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System (2015), 280 descendants of its own
- K150788: Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices (2015), 202 descendants of its own
- K160924: Amendia Interbody Fusion Devices (2016), 166 descendants of its own
- K171496: Tritanium C Anterior Cervical Cage (2017), 129 descendants of its own
- K150619: CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System (2015), 107 descendants of its own

## Indications for use
The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (02-Ti), in skeletally mature patients with degenerative disc disease (DODD). DOD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACPor Hallmark® System). Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Source page: https://510kreport.com/device/K121649
Methodology: https://510kreport.com/methodology