# K172185: Tyber Medical PT Interbody Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Dec 21, 2017 after 154 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). 114 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130573: Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif, Tyber Medical, LLC (2013) Summary page 4.
- K120275: Synthes Acis/Vertebral Spacer CR, Synthes (Usa), LLC (2012) Summary page 4.
- K101923: Concorde Curve System, Depuy Spine (2010) Summary page 4.
- K090899: Depuy Spine Lateral System, Depuy Spine, Inc. (2009) Summary page 4.
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space, Aesculap Implant Systems, Inc. (2008) Summary page 4.

## Most influential descendants
- K180590: Tyber Medical PT Interbody Spacer System (2018), 6 descendants of its own
- K182284: Tyber Medical PT Interbody Spacer (2019), 5 descendants of its own
- K230583: Tryptik Ti (2023), 1 descendant of its own
- K192897: icotec Cervical Cage (2020), 1 descendant of its own
- K250605: EVOL® ha – Hyper C Cervical Interbody Fusion System (2025), 0 descendants of its own

## Indications for use
Lumbar System Indications The Tyber Medical PT Interbody System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine. Cervical System Indications The Tyber Medical PT Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.

Source page: https://510kreport.com/device/K172185
Methodology: https://510kreport.com/methodology