# K103814: Pezo Interbody Cages System

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Mar 17, 2011 after 78 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: 6 generations back to K010530 (2001). 15 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 2.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 2.
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 2.
- K082014: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2008) Summary page 2.
- K083661: Avs TL Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K090166: Avs Anterior Large Peek Spacers, Stryker Corp. (2009) Summary page 2.

## Most influential descendants
- K152620: Spine Wave Gen II Expandable Interbody System (2016), 2 descendants of its own
- K162760: Spine Wave Anterior Cervical Spine System (2017), 1 descendant of its own
- K173175: Paramount Anterior Cervical Cage System (2017), 0 descendants of its own
- K122957: Tezo Titanium Cage Family (2013), 0 descendants of its own

## Indications for use
pezoTM is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DOD) with up to Grade I spondylolisthesis or retrolisthesis. DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K103814
Methodology: https://510kreport.com/methodology