510(k) · Cleared
ClearedAvenue P Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Biomet Spine, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jan 15, 2019 as substantially equivalent to K151773 (Medos International SARL, 2015) and 4 other predicates after a 264-day review. Its family tree reaches back 18 generations to 1984.
- Decided
- Jan 15, 2019
- Review
- 264 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K841189 (1984). 164 ancestors in all. No later device cites it as a predicate yet.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 2 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 1 generation backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- This deviceK181096 Avenue P Cage SystemZimmer Biomet Spine, Inc. · 2019
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 7 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 6 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 5 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 4 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 3 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 2 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 1 generation backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- This deviceK181096 Avenue P Cage SystemZimmer Biomet Spine, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −7 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −6 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −5 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −4 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −3 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −2 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −1 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| 0 (this device) | K181096 | Avenue P Cage System | Zimmer Biomet Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 9 | 0 |
| 2004 | 15 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 24 | 0 |
| 2009 | 17 | 0 |
| 2010 | 7 | 0 |
| 2011 | 13 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OVD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151773 | CONCORDE Bullet Lumbar Interbody SystemSummary page 5…eristics: The technological characteristics of the subject Avenue® P cage system components remain the same as, or similar to, the ƉƌŝŵĂƌLJ predicate, CONCORDE® Bullet (K151773), ĂŶĚ ƚŚĞ ĂĚĚŝƚŝŽŶĂů predicateƐ, Lucent Ti-Bond Systems (K150061)͕ Biomet Spine Fusion System (K153695), Avenue T TLIF Cage (K… | 2015 |
| * | K150061 | Lucent; Lucent Ti-Bond SystemsSummary page 5…P cage system components remain the same as, or similar to, the ƉƌŝŵĂƌLJ predicate, CONCORDE® Bullet (K151773), ĂŶĚ ƚŚĞ ĂĚĚŝƚŝŽŶĂů predicateƐ, Lucent Ti-Bond Systems (K150061)͕ Biomet Spine Fusion System (K153695), Avenue T TLIF Cage (K142645) and ROI-C Titanium-Coated Implant System (K151934) in regard… | 2015 |
| * | K153695 | Biomet Spine Fusion SystemSummary page 5…me as, or similar to, the ƉƌŝŵĂƌLJ predicate, CONCORDE® Bullet (K151773), ĂŶĚ ƚŚĞ ĂĚĚŝƚŝŽŶĂů predicateƐ, Lucent Ti-Bond Systems (K150061)͕ Biomet Spine Fusion System (K153695), Avenue T TLIF Cage (K142645) and ROI-C Titanium-Coated Implant System (K151934) in regards to intended use, indications for use… | 2016 |
| * | K142645 | Avenue T TLIF CageSummary page 5…ĂƌLJ predicate, CONCORDE® Bullet (K151773), ĂŶĚ ƚŚĞ ĂĚĚŝƚŝŽŶĂů predicateƐ, Lucent Ti-Bond Systems (K150061)͕ Biomet Spine Fusion System (K153695), Avenue T TLIF Cage (K142645) and ROI-C Titanium-Coated Implant System (K151934) in regards to intended use, indications for use, design, manufacturing method… | 2015 |
| * | K151934 | ROI-C Titanium-Coated Implant SystemSummary page 5…Ğ ĂĚĚŝƚŝŽŶĂů predicateƐ, Lucent Ti-Bond Systems (K150061)͕ Biomet Spine Fusion System (K153695), Avenue T TLIF Cage (K142645) and ROI-C Titanium-Coated Implant System (K151934) in regards to intended use, indications for use, design, manufacturing methods, fundamental technology, and operational principl… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 17 of the 164 ancestors have a recall of any class.
- 6 other devices also cite its predicate K151773.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
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…
Read the full statement (146 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181096: Avenue P Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181096
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026