510(k) · Cleared
ClearedOsteomni Spinal Cages System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomni, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on May 12, 2026 as substantially equivalent to K252686 (Effortmed, LLC, 2025) after a 57-day review. Its family tree reaches back 29 generations to 1984. 1 of the 527 devices in its family, counting itself, has a Class I recall.
- Decided
- May 12, 2026
- Review
- 57 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 29 generations to K841189 (1984). 526 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 527 devices in this family, counting this one, has a Class I recall.
- Root · 29 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations between
- 3 generations backK212358 Romero Cervical CageSpineup, Inc. · 2022
- 2 generations backK240893 ARTFX MEDICAL Cervical PEEK CagesArtfx Medical · 2024
- 1 generation backK252686 EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC · 2025
- This deviceK260850 Osteomni Spinal Cages SystemOsteomni, Inc. · 2026
Show all 29 generations
- Root · 29 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 28 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 27 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 26 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 25 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 24 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 23 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 22 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 21 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 20 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 19 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 18 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 17 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 16 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 15 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 14 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 13 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 12 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 11 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 10 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 9 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 8 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 7 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 6 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 5 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 4 generations backK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
- 3 generations backK212358 Romero Cervical CageSpineup, Inc. · 2022
- 2 generations backK240893 ARTFX MEDICAL Cervical PEEK CagesArtfx Medical · 2024
- 1 generation backK252686 EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC · 2025
- This deviceK260850 Osteomni Spinal Cages SystemOsteomni, Inc. · 2026
Class I recalls in this family
- K073202 Ardis Spacer11 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −29 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −28 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −27 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −26 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −25 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −24 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −23 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −22 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −21 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −20 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −19 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −18 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −17 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −16 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −15 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −14 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −13 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −12 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −11 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −10 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −9 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −8 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −7 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −6 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −5 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −4 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
| −3 | K212358 | Romero Cervical Cage | Spineup, Inc. | 2022 | — |
| −2 | K240893 | ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical | 2024 | — |
| −1 | K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | 2025 | — |
| 0 (this device) | K260850 | Osteomni Spinal Cages System | Osteomni, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 8 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 10 | 0 |
| 2001 | 17 | 0 |
| 2002 | 16 | 0 |
| 2003 | 23 | 0 |
| 2004 | 33 | 0 |
| 2005 | 28 | 0 |
| 2006 | 20 | 0 |
| 2007 | 21 | 0 |
| 2008 | 55 | 1 |
| 2009 | 35 | 0 |
| 2010 | 24 | 0 |
| 2011 | 35 | 0 |
| 2012 | 25 | 0 |
| 2013 | 26 | 0 |
| 2014 | 25 | 0 |
| 2015 | 23 | 0 |
| 2016 | 9 | 0 |
| 2017 | 11 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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.
1 device in this family has a Class I recall. 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K252686 | EffortMed PEEK Cages & Corpectomy CagesSummary page 6…ode(s) ODP, OVE, MAX, MQP, PLR I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K252686 EffortMed PEEK Cages & Corpectomy Cages ODP, OVE, I Device Description Summary 21 CFR 807.92(a)(4) The OSTEOMNI SPINAL CAGES SYS… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 11 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 17 companies; a new generation was cleared every 10 months on median.
- 64 of the 526 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
OSTEOMNI CERVICAL PEEK CAGES are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six (6) weeks of prior non-operative treatment. Cervical Peek Cages facilitate intervertebral…
Read the full statement (587 words)
OSTEOMNI CERVICAL PEEK CAGES are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six (6) weeks of prior non-operative treatment. Cervical Peek Cages facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and packed with autogenous bone. OSTEOMNI CERVICAL PEEK CAGES are to be used with supplemental fixation.
OSTEOMNI CERVICAL Ti CAGES are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six (6) weeks of prior non-operative treatment. Cervical Ti-Cages facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and packed with autogenous bone. OSTEOMNI CERVICAL Ti CAGES are to be used with supplemental fixation.
OSTEOMNI LUMBAR PEEK CAGES are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/autologous bone graft to facilitate fusion for each spinal region.
OSTEOMNI LUMBAR Ti CAGES are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/autologous bone graft to facilitate fusion for each spinal region.
OSTEOMNI CERVICAL CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
OSTEOMNI LUMBAR CORPECTOMY CAGE is intended for use in skeletally mature patients in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
OSTEOMNI CORPECTOMY CAGES are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
OSTEOMNI CORPECTOMY CAGES are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260850 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260850: Osteomni Spinal Cages System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260850
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026