510(k) · Cleared
Recalled · Class II · 2021Chesapeake (Cervical Components)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Aug 24, 2011 as substantially equivalent to K092211 (K2m, Inc., 2010) and 5 other predicates after a 92-day review. Its family tree reaches back 13 generations to 1984. 345 later devices descend from it. It has been recalled once.
- Decided
- Aug 24, 2011
- Review
- 92 days
- Class
- Class II
- Product code
- OVE
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 13 generations to K841189 (1984). 75 ancestors in all. 345 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 1 generation backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- This deviceK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011
- 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 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 1 generation backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- This deviceK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011
Showing 5 of 345 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 345 · 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 |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −3 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −2 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −1 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| 0 (this device) | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | — |
| +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 | 10 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 10 | 0 |
| 2009 | 4 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 11 | 0 |
| 2018 | 13 | 0 |
| 2019 | 19 | 0 |
| 2020 | 34 | 0 |
| 2021 | 31 | 0 |
| 2022 | 41 | 0 |
| 2023 | 49 | 0 |
| 2024 | 43 | 0 |
| 2025 | 47 | 0 |
| 2026 | 45 | 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 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 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K092211 | Chesapeake Spinal System | 2010 |
| * | K051454 | Aleutian Spacer SystemSummary page 1…ory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent " K2M Chesapeake (K409221 1) * K2M Aleutian (K4051454, K4082698) * Surgicraft Stalif C (K407241I5) * Globus Coalition (K4083389) " Cardinal Spine STCC (K100698) 4.… | 2005 |
| * | K082698 | Aleutian Ibf SystemSummary page 1…Class 11 3. Predicate or legally marketed devices which are substantially equivalent " K2M Chesapeake (K409221 1) * K2M Aleutian (K4051454, K4082698) * Surgicraft Stalif C (K407241I5) * Globus Coalition (K4083389) " Cardinal Spine STCC (K100698) 4. Descriptio… | 2009 |
| * | K072415 | Stalif (TM) C | 2008 |
| * | K083389 | Coalition SpacerSummary page 1…e substantially equivalent " K2M Chesapeake (K409221 1) * K2M Aleutian (K4051454, K4082698) * Surgicraft Stalif C (K407241I5) * Globus Coalition (K4083389) " Cardinal Spine STCC (K100698) 4. Description of the device: The Chesapeake Spinal System consists of interbody… | 2009 |
| * | K100698 | STCCSummary page 1…M Chesapeake (K409221 1) * K2M Aleutian (K4051454, K4082698) * Surgicraft Stalif C (K407241I5) * Globus Coalition (K4083389) " Cardinal Spine STCC (K100698) 4. Description of the device: The Chesapeake Spinal System consists of interbody implants and titanium bone screws in… | 2011 |
What descends from it? (345)
See all 3454 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2021 | Class II | Z-1410-2021 | Under Investigation by firm | Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 11 of the 75 ancestors have a recall of any class.
- Of its descendants, K133494 (K2m, Inc., 2014) has gone furthest, with 330 descendants of its own.
- 4 other devices also cite its predicate K092211.
How does its category compare?
All OVE devicesOVE 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
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation.
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 IBF implants are intended for use at one level in the cervical spine, from C2 to T I, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111439 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111439: Chesapeake (Cervical Components).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111439
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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