# K181096: Avenue P Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Biomet Spine, Inc.
- Decided: Jan 15, 2019 after 264 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 18 generations back to K841189 (1984). 164 ancestors in all.
No later device cites it as a predicate yet.
0 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151773: CONCORDE Bullet Lumbar Interbody System, Medos International SARL (2015) Summary page 5.
- K150061: Lucent; Lucent Ti-Bond Systems, Spinal Elements, Inc. (2015) Summary page 5.
- K153695: Biomet Spine Fusion System, Biomet Spine, LLC (2016) Summary page 5.
- K142645: Avenue T TLIF Cage, Ldr Spine USA, Inc. (2015) Summary page 5.
- K151934: ROI-C Titanium-Coated Implant System, Ldr Spine USA (2015) Summary page 5.

## Indications for use
Avenue P 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 (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device is implanted via a transforaminal or posterior approach and intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Avenue P is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation cleared for use as an adjunct to fusion in the lumbar spine.

Source page: https://510kreport.com/device/K181096
Methodology: https://510kreport.com/methodology