510(k) · Cleared
ClearedChesapeake Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Mar 16, 2012 as substantially equivalent to K082698 (K2m, Inc., 2009) and 5 other predicates after a 72-day review. Its family tree reaches back 12 generations to 1984. 334 later devices descend from it.
- Decided
- Mar 16, 2012
- Review
- 72 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K841189 (1984). 57 ancestors in all. 334 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 2 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 1 generation backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- This deviceK120031 Chesapeake Spinal SystemK2m, Inc. · 2012
- Descendant · cites it directly · 330 of its ownK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- Descendant · 2 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 3 generations on · 169 of its ownK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- Descendant · 3 generations on · 145 of its ownK171140 Matrixx SystemNexxt Spine, LLC · 2017
- Descendant · 2 generations on · 111 of its ownK142940 Endoskeleton TCS SystemTitan Spine, LLC · 2015 · Recalled
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 2 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 1 generation backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- This deviceK120031 Chesapeake Spinal SystemK2m, Inc. · 2012
Showing 5 of 334 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 334 · See all- K133494Chesapeake Spinal SystemK2m, Inc. · 2014 · cites it directly330descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 2 generations on315descendants
- K162264Cascadia Interbody SystemK2m, Inc. · 2016 · 3 generations on169descendants
- K171140Matrixx SystemNexxt Spine, LLC · 2017 · 3 generations on145descendants
- K142940Endoskeleton TCS SystemTitan Spine, LLC · 2015 · 2 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −2 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −1 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| 0 (this device) | K120031 | Chesapeake Spinal System | K2m, Inc. | 2012 | — |
| +1 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| +2 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +3 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| +3 | K171140 | Matrixx System | Nexxt Spine, LLC | 2017 | — |
| +2 | K142940 | Endoskeleton TCS System | Titan Spine, LLC | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 10 | 0 |
| 2018 | 11 | 0 |
| 2019 | 19 | 0 |
| 2020 | 34 | 0 |
| 2021 | 31 | 0 |
| 2022 | 41 | 0 |
| 2023 | 47 | 0 |
| 2024 | 40 | 0 |
| 2025 | 46 | 0 |
| 2026 | 44 | 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K095454 | K2M Aleutian Interbody Spacer Systems Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K082698 | Aleutian Ibf SystemSummary page 2…ided which demonstrated that the subject Chesapeake Spinal System components are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (KOS51454, K082698), Surgicraft Stalif System (K073 109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet S… | 2009 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 2…sapeake Spinal System components are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (KOS51454, K082698), Surgicraft Stalif System (K073 109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (KO81501). 6. Comparison of the te… | 2008 |
| * | K062083 | Synfix -LRSummary page 2…nents are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (KOS51454, K082698), Surgicraft Stalif System (K073 109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (KO81501). 6. Comparison of the technological characteristic… | 2007 |
| * | K072253 | Synfix-LR SpacerSummary page 2…are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (KOS51454, K082698), Surgicraft Stalif System (K073 109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (KO81501). 6. Comparison of the technological characteristics of the… | 2007 |
| * | K083475 | Lucent MagnumSummary page 2…valent to the K2M Aleutian Interbody Spacer Systems (KOS51454, K082698), Surgicraft Stalif System (K073 109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (KO81501). 6. Comparison of the technological characteristics of the device to predicate and leg… | 2009 |
| * | K081501 | Solitaire Anterior Spinal System | 2008 |
What descends from it? (334)
See all 3344 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 28 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 8 of the 57 ancestors have a recall of any class.
- Of its descendants, K133494 (K2m, Inc., 2014) has gone furthest, with 330 descendants of its own.
- 21 other devices also cite its predicate K082698.
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. 2012, 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?
When used as a cervical intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBE implants are intended for use at one level in the cervical spine, from C2 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…
Read the full statement (252 words)
When used as a cervical intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBE implants are intended for use at one level in the cervical spine, from C2 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 intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar I implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
The Chesapeake spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device the Chesapeake spacers are intended to be used with the bone screws provided. When using a 2 screw implant, 2 screws must be used. When using a 3 screw implant 3 screws must be used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120031 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120031: Chesapeake Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120031
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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