# K101812: Construx Mini Peek Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Sep 27, 2010 after 90 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: 9 generations back to K841189 (1984). 48 ancestors in all.
291 later devices descend from it; 3 cite it directly.
0 of 340 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051246: Construx Mini Peek VBR System, Blackstone Medical, Inc. (2005)
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 2.
- K092904: Pathway Ivb/VBR, Custom Spine, Inc. (2009) Summary page 2.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 2.

## Most influential descendants
- K121649: Construx Mini Peek TI Spacer System (2012), 289 descendants of its own
- K132999: Cervical Stand Alone System (2014), 281 descendants of its own
- 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

## Indications for use
When used as a cervical intervertebral body fusion device, the Construx Mini PEEK 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 System is intended for use with autograft and supplemental internal fixation, e.g.: the Blackstone Medical 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 System in the cervical spine. The Construx Mini PEEK device is used singly and is implanted using an anterior approach. When used as a Partial Vertebral Body Replacement (VBR) System the Construx Mini PEEK 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 System is also indicated for treating fractures of the thoracic and lumbar spine. The Construx Mini PEEK 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 System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the Construx Mini PEEK System is the Blackstone Medical Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.

Source page: https://510kreport.com/device/K101812
Methodology: https://510kreport.com/methodology