510(k) Report

510(k) · Cleared

Cleared

Rhausler Plage Anterior Cervical Fusion System

K111272510(k) AbbreviatedCleared Nov 29, 2011209-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Rhausler, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Cleared on Nov 29, 2011 as substantially equivalent to K071833 (Spinal Elements, Inc., 2007) and 1 other predicate after a 209-day review. Its family tree reaches back 5 generations to 2001. 7 later devices descend from it.

Decided
Nov 29, 2011
Review
209 days
Class
Class II
Product code
OVE
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K010530 (2001). 12 ancestors in all, the oldest P950002 (1996). 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestor2002: 2 other ancestors2001: 1 other ancestor1996: 1 other ancestor2016: 1 descendant cleared2018: 1 descendant cleared2015: 1 descendant cleared2025: 2 descendants cleared2021: 1 descendant cleared2026: 1 descendant clearedK010530 · Geo Structure · Interpore Cross Intl. · 2001K062083 · Synfix -LR · Synthes Spine Co.Lp · 2007×2: 2 generations cleared close together, K072253 (2007), K072981 (2008) K092521 · ZUMA-C · Seaspine, Inc. · 20101995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants K092521 · ZUMA-C · Seaspine, Inc. · 2010K072981 · Synthes Zero-P · Synthes Spine Co.Lp · 2008 · recalledK072253 · Synfix-LR Spacer · Synthes Spine Co.Lp · 2007 · recalledK062083 · Synfix -LR · Synthes Spine Co.Lp · 2007K010530 · Geo Structure · Interpore Cross Intl. · 2001−50
  1. Root · 5 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
  2. 4 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
  3. 3 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
  4. 2 generations backK072981 Synthes Zero-PSynthes Spine Co.Lp · 2008 · Recalled
  5. 1 generation backK092521 ZUMA-CSeaspine, Inc. · 2010
  6. This deviceK111272 Rhausler Plage Anterior Cervical Fusion SystemRhausler, Inc. · 2011
  7. Descendant · cites it directly · 2 of its ownK173128 Alamo® CAlliance Partners, LLC · 2018
  8. Descendant · cites it directly · 1 of its ownK251735 Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC · 2025
  9. Descendant · 2 generations on · 0 of its ownK254130 C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026
  10. Descendant · 2 generations on · 0 of its ownK252737 DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical · 2025
  11. Descendant · 2 generations on · 0 of its ownK213115 CHENA-C Spacer SystemKahtnu Surgical, Inc. · 2021

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12018: 12021: 12025: 22026: 1
2015high 2 (2025) · low 0 (2017)2026

Most influential descendants

Showing 5 of 7 · See all
  • K173128Alamo® CAlliance Partners, LLC · 2018 · cites it directly2descendants
  • K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC · 2025 · cites it directly1descendant
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026 · 2 generations on0descendants
  • K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical · 2025 · 2 generations on0descendants
  • K213115CHENA-C Spacer SystemKahtnu Surgical, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K010530Geo StructureInterpore Cross Intl.2001—
−4K062083Synfix -LRSynthes Spine Co.Lp2007—
−3K072253Synfix-LR SpacerSynthes Spine Co.Lp20071
−2K072981Synthes Zero-PSynthes Spine Co.Lp20082
−1K092521ZUMA-CSeaspine, Inc.2010—
0 (this device)K111272Rhausler Plage Anterior Cervical Fusion SystemRhausler, Inc.2011—
+1K173128Alamo® CAlliance Partners, LLC2018—
+1K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC2025—
+2K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC2026—
+2K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical2025—
+2K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200110
200220
200710
200810
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201810
202110
202520
202610
FIG. 1 — Lineage of K111272, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OVE? 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 OVE device

  1. #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K071833Mosaic Devices
Summary page 1
…stem Classification Name: Intervertebral body fusion device Classification: 21 CFR 888.3080, Class 11, Product Code ODP Predicate Devices: K071833 MosaicTM by Spinal Elements Inc. K092521 Zuma-CTh by Seaspine Inc. Device Description: The R…
Spinal Elements, Inc.2007—
*K092521ZUMA-C
Summary page 1
…Classification: 21 CFR 888.3080, Class 11, Product Code ODP Predicate Devices: K071833 MosaicTM by Spinal Elements Inc. K092521 Zuma-CTh by Seaspine Inc. Device Description: The Rhausler Plage Anterior Cervical Fusion System consists of…
Seaspine, Inc.2010—

Also cleared against K071833: 7 other devices →

What descends from it? (7)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173128Alamo® CAlliance Partners, LLC20182
K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251
K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160
K150455RT2 Trabeculite Titanium Cervical Cage SystemRhausler, Inc.20150

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 10 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • 2 of the 12 ancestors have a recall of any class.
  • Of its descendants, K173128 (Alliance Partners, LLC, 2018) has gone furthest, with 2 descendants of its own.
  • 7 other devices also cite its predicate K071833.

How does its category compare?

All OVE devices

OVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OVE

10in 2025

2007: 12008: 42009: 12010: 42011: 82012: 72013: 52014: 112015: 122016: 152017: 92018: 72019: 72020: 132021: 102022: 102023: 162024: 62025: 102026 (partial year): 13
2007high 16 (2023) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVE

105in 2025

2008: 131 days median2010: 210 days median2011: 139 days median2012: 125 days median2013: 71 days median2014: 168 days median2015: 113 days median2016: 149 days median2017: 100 days median2018: 105 days median2019: 87 days median2020: 149 days median2021: 93 days median2022: 144 days median2023: 97 days median2024: 56 days median2025: 105 days median2026 (partial year): 66 days median
2007high 210 (2010) · low 56 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OVE

2in 2021

2013: 12014: 12015: 12016: 12017: 12021: 2
2007high 2 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVE

132in 2025

2010: 22011: 192012: 592013: 2502014: 1502015: 1732016: 1452017: 1342018: 2102019: 1692020: 1622021: 1862022: 2002023: 1482024: 1422025: 132
2007high 250 (2013) · low 0 (2007)2025

MAUDE reports naming product code OVE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
2008413100
20091—00
2010421002
20118139019
20127125059
20135711250
2014111681150
2015121131173
2016151491145
201791001134
201871050210
20197870169
2020131490162
202110932186
2022101440200
202316970148
20246560142
2025101050132
202613660—

What is it indicated for?

Intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have had at least 6 weeks of nonoperative treatment.

Indications for use as stated in the FDA summary.

Also cleared against K071833

7 other devices cite the same predicate.

  • K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies · 2020
  • K192906Mecta-C Stand AloneMedacta International S.A. · 2020
  • K181621Stable-C Interbody SystemNexus Spine, LLC · 2018
  • K133218Crystal ®; Mosaic ®; Vertu ®Spinal Elements, Inc. · 2014
  • K122771Spinal Elements Cervical Intervertebral Body Fusion SystemSpinal Elements, Inc. · 2013
  • K120819Stalif CCentinel Spine, Inc. · 2012

More from Rhausler, Inc.

2 FDA decisions under this applicant name. See the company

  • K150455RT2 Trabeculite Titanium Cervical Cage SystemRhausler, Inc. · 2015

Recent decisions in OVE

The OVE category page

  • K263113ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
  • K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
  • K263049SABER-C SystemElevation Spine · 2026
  • K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
  • K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026

https://510kreport.com/device/K111272 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111272: Rhausler Plage Anterior Cervical Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111272

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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