510(k) · Cleared
ClearedC-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rsb Spine, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jan 27, 2010 as substantially equivalent to K081194 (Rsb Spine, LLC, 2008) and 4 other predicates after a 161-day review. Its family tree reaches back 10 generations to 1984. 45 later devices descend from it.
- Decided
- Jan 27, 2010
- Review
- 161 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K841189 (1984). 44 ancestors in all. 45 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- This deviceK092540 C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar…Rsb Spine, LLC · 2010
- Descendant · cites it directly · 43 of its ownK120656 Everest Spinal SystemK2m, Inc. · 2012
- Descendant · 2 generations on · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013
- Descendant · 2 generations on · 34 of its ownK132361 Everest Spinal SystemK2m, Inc. · 2013
- Descendant · 2 generations on · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- Descendant · 2 generations on · 31 of its ownK140529 Everest Spinal SystemK2m, LLC · 2014
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 4 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- This deviceK092540 C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar…Rsb Spine, LLC · 2010
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K120656Everest Spinal SystemK2m, Inc. · 2012 · cites it directly43descendants
- K132757Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on41descendants
- K132361Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on34descendants
- K133944Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014 · 2 generations on33descendants
- K140529Everest Spinal SystemK2m, LLC · 2014 · 2 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −4 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −3 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K073177 | Pioneer Intervertebral Fusion Device System | Pioneer Surgical Technology | 2008 | 1 |
| 0 (this device) | K092540 | C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody… | Rsb Spine, LLC | 2010 | — |
| +1 | K120656 | Everest Spinal System | K2m, Inc. | 2012 | — |
| +2 | K132757 | Everest Spinal System | K2m, Inc. | 2013 | — |
| +2 | K132361 | Everest Spinal System | K2m, Inc. | 2013 | — |
| +2 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| +2 | K140529 | Everest Spinal System | K2m, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 ODP? 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? (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 |
|---|---|---|---|
| * | K081194 | Interplate Peek Cervical Interbody Fusion Device (Ifd) | 2008 |
| * | K073177 | Pioneer Intervertebral Fusion Device SystemSummary page 2…substantially equivalent to the previously cleared devices including the InterPlateTM PEEK Cervical IFD (KO8i1194), Pioneer Cervical IBF (K073 177), Pioneer vertebral spacer (K043206), InterPlateTM IFD (K071922) and the MC+ (K043479). The substantial equivalenc… | 2008 |
| * | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Summary page 2…viously cleared devices including the InterPlateTM PEEK Cervical IFD (KO8i1194), Pioneer Cervical IBF (K073 177), Pioneer vertebral spacer (K043206), InterPlateTM IFD (K071922) and the MC+ (K043479). The substantial equivalence is based upon equiv… | 2005 |
| * | K071922 | Interplate Interbody Fusion Device, Models C, CGC, L and LGCSummary page 2…InterPlateTM PEEK Cervical IFD (KO8i1194), Pioneer Cervical IBF (K073 177), Pioneer vertebral spacer (K043206), InterPlateTM IFD (K071922) and the MC+ (K043479). The substantial equivalence is based upon equivalence in basic design, intended use, indic… | 2007 |
| * | K043479 | MC+ Partial VBRSummary page 2…PEEK Cervical IFD (KO8i1194), Pioneer Cervical IBF (K073 177), Pioneer vertebral spacer (K043206), InterPlateTM IFD (K071922) and the MC+ (K043479). The substantial equivalence is based upon equivalence in basic design, intended use, indications, performance… | 2005 |
What descends from it? (45)
See all 452 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 44 ancestors have a recall of any class.
- Of its descendants, K120656 (K2m, Inc., 2012) has gone furthest, with 43 descendants of its own.
- 1 other device also cites its predicate K081194.
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. 2010, 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?
The C-PS is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The C-PS is intended for use at one level in the cervical spine, from C3 to TI, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and…
Read the full statement (229 words)
The C-PS is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The C-PS is intended for use at one level in the cervical spine, from C3 to TI, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The C-PS is intended to be used with a Supplemental internal fixation system.
The L-PS is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The L-PS System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, for the treatment of degenerative disc disease (DDD) with Lip to Grade I spondylolisthesis. DIDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. Thle L-PS is intended to be used with a supplemental internal fixation system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092540: C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092540
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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