# K182284: Tyber Medical PT Interbody Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Jan 18, 2019 after 148 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: 20 generations back to K841189 (1984). 318 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 324 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180590: Tyber Medical PT Interbody Spacer System, Tyber Medical, LLC (2018) Summary page 4.
- K163491: NuVasive CoRoent Small Interbody System, Nu Vasive, Incorporated (2017) Summary page 4.
- K173722: PATRIOT COLONIAL Spacer, SUSTAIN Spacer, Globus Medical, Inc. (2018) Summary page 4.
- K130573: Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif, Tyber Medical, LLC (2013) Summary page 4.
- K172185: Tyber Medical PT Interbody Spacer System, Tyber Medical, LLC (2017) Summary page 4.

## Most influential descendants
- 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
- K240699: SCARLET® AC-Ti (2024), 0 descendants of its own
- K232792: icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage) (2024), 0 descendants of its own

## Indications for use
Cervical System Indications: The Tyber Medical PT Cervical Interbody Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. Tyber Medical PT Cervical Interbody spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K182284
Methodology: https://510kreport.com/methodology