# K110562: Telamon Peek Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA
- Decided: Nov 9, 2011 after 254 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 11 generations back to K841189 (1984). 39 ancestors in all.
306 later devices descend from it; 2 cite it directly.
1 of 346 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031780: Verte-Stack Spinal System, Medtronic Sofamor Danek (2003) Summary page 2.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 2.
- K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010) Summary page 2.
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 2.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 2.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 2.

## Most influential descendants
- K122037: Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst (2013), 281 descendants of its own
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (2015), 228 descendants of its own
- K152277: PIVOX (tm) Oblique Lateral Spinal System (2015), 190 descendants of its own
- K161379: ELSA Spacers (2016), 155 descendants of its own
- K121982: Sovereign Spinal System (2012), 155 descendants of its own

## Indications for use
The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous bone graft in patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to SI1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft and are intended for bilateral placement in the lumbar spine. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K110562
Methodology: https://510kreport.com/methodology