# K142152: Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Jan 8, 2015 after 155 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: 14 generations back to K003155 (2001). 89 ancestors in all.
280 later devices descend from it; 6 cite it directly.
0 of 370 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130177: Anatomic Peek Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 5.
- K133653: Anatomic Peek PTC Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.
- K132999: Cervical Stand Alone System, Orthofix, Inc. (2014) Summary page 5.
- K101812: Construx Mini Peek Spacer System, Orthofix, Inc. (2010) Summary page 5.
- K121649: Construx Mini Peek TI Spacer System, Orthofix (2012) Summary page 5.

## Most influential descendants
- 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
- K180364: HD LifeSciences Cervical IBFD System (2018), 106 descendants of its own

## Indications for use
CONSTRUX Mini PEEK Spacer System When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The CONSTRUX Mini PEEK Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g.: the Ascent™ or Ascent LE™ POCT 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 Spacer System in the cervical spine. When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft. The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System. CONSTRUX Mini PEEK Ti Spacer System The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD 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 /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or 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. Cervical Stand Alone System The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The Cervical Stand Alone System is used with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.

Source page: https://510kreport.com/device/K142152
Methodology: https://510kreport.com/methodology