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 Jun 10, 2014 as substantially equivalent to K092211 (K2m, Inc., 2010) and 5 other predicates after a 208-day review. Its family tree reaches back 14 generations to 1984. 330 later devices descend from it.
- Decided
- Jun 10, 2014
- Review
- 208 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K841189 (1984). 104 ancestors in all, the oldest K792352 (1979). 330 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 2 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 1 generation backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- This deviceK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- Descendant · cites it directly · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 2 generations on · 169 of its ownK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- Descendant · 2 generations on · 145 of its ownK171140 Matrixx SystemNexxt Spine, LLC · 2017
- Descendant · cites it directly · 111 of its ownK142940 Endoskeleton TCS SystemTitan Spine, LLC · 2015 · Recalled
- Descendant · 2 generations on · 110 of its ownK151596 Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 2015 · Recalled
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 4 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 3 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 2 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 1 generation backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- This deviceK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
Showing 5 of 330 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 330 · See all- K160125Cascadia Interbody SystemK2m · 2016 · cites it directly315descendants
- K162264Cascadia Interbody SystemK2m, Inc. · 2016 · 2 generations on169descendants
- K171140Matrixx SystemNexxt Spine, LLC · 2017 · 2 generations on145descendants
- K142940Endoskeleton TCS SystemTitan Spine, LLC · 2015 · cites it directly111descendants
- K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 2015 · 2 generations on110descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −4 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −3 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −2 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| −1 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| 0 (this device) | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| +1 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +2 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| +2 | K171140 | Matrixx System | Nexxt Spine, LLC | 2017 | — |
| +1 | K142940 | Endoskeleton TCS System | Titan Spine, LLC | 2015 | 2 |
| +2 | K151596 | Endoskeleton TCS Interbody Fusion Device | Titan Spine, LLC | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 17 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 7 | 0 |
| 2008 | 14 | 0 |
| 2009 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 10 | 0 |
| 2018 | 10 | 0 |
| 2019 | 18 | 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? (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 SystemSummary page 1…Regulation Number: 888.3080 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Chesapeake Spinal Stabilization System (K092211, K1]1439, K120031) * Medtronic PEEK Prevail (K073285) * Centinal Stalif- C (K0724 15) * SpineSmith IN-C2 (K122630)… | 2010 |
| * | K111439 | Chesapeake (Cervical Components) | 2011 |
| * | K120031 | Chesapeake Spinal SystemSummary page 1…er: 888.3080 3. Predicate or legally marketed devices which are substantially equivalent: * K2M Chesapeake Spinal Stabilization System (K092211, K1]1439, K120031) * Medtronic PEEK Prevail (K073285) * Centinal Stalif- C (K0724 15) * SpineSmith IN-C2 (K122630) 4. Description of… | 2012 |
| * | K073285 | Peek Prevail Cervical Interbody DeviceSummary page 1…r legally marketed devices which are substantially equivalent: * K2M Chesapeake Spinal Stabilization System (K092211, K1]1439, K120031) * Medtronic PEEK Prevail (K073285) * Centinal Stalif- C (K0724 15) * SpineSmith IN-C2 (K122630) 4. Description of the device: The Chesapeake Spina… | 2008 |
| * | K072415 | Stalif (TM) CSummary page 1…e substantially equivalent: * K2M Chesapeake Spinal Stabilization System (K092211, K1]1439, K120031) * Medtronic PEEK Prevail (K073285) * Centinal Stalif- C (K0724 15) * SpineSmith IN-C2 (K122630) 4. Description of the device: The Chesapeake Spinal System consists of PEEK and titani… | 2008 |
| * | K122630 | IN:C2 Spinal Fixation SystemSummary page 1…K2M Chesapeake Spinal Stabilization System (K092211, K1]1439, K120031) * Medtronic PEEK Prevail (K073285) * Centinal Stalif- C (K0724 15) * SpineSmith IN-C2 (K122630) 4. Description of the device: The Chesapeake Spinal System consists of PEEK and titanium spacers and titanium bone… | 2012 |
What descends from it? (330)
See all 3304 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 30 years and passes through 11 companies; a new generation was cleared every 1.1 years on median.
- 12 of the 104 ancestors have a recall of any class.
- Of its descendants, K160125 (K2m, 2016) has gone furthest, with 315 descendants of its own.
- 4 other devices also cite its predicate K092211.
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. 2014, 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 IBF implants are intended for use at one level in the cervical spine, from C2 to T1, 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 (251 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 IBF implants are intended for use at one level in the cervical spine, from C2 to T1, 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 implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I 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/K133494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133494: Chesapeake Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133494
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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