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 5, 2010 as substantially equivalent to K051454 (K2m, LLC, 2005) and 6 other predicates after a 226-day review. Its family tree reaches back 12 generations to 1984. 450 later devices descend from it.
- Decided
- Mar 5, 2010
- Review
- 226 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. 450 later devices descend from it, 5 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 deviceK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- Descendant · cites it directly · 345 of its ownK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 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 · cites it directly · 269 of its ownK131122 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC · 2013
- Descendant · 2 generations on · 265 of its ownK140106 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
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 deviceK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
Showing 5 of 450 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 450 · See all- K111439Chesapeake (Cervical Components)K2m, Inc. · 2011 · cites it directly345descendants
- K133494Chesapeake Spinal SystemK2m, Inc. · 2014 · cites it directly330descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 2 generations on315descendants
- K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC · 2013 · cites it directly269descendants
- K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014 · 2 generations on265descendants
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) | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| +1 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| +1 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| +2 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +1 | K131122 | S128 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, LLC | 2013 | — |
| +2 | K140106 | S128 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, Inc. | 2014 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 12 | 0 |
| 2018 | 24 | 0 |
| 2019 | 22 | 0 |
| 2020 | 46 | 0 |
| 2021 | 40 | 0 |
| 2022 | 50 | 0 |
| 2023 | 65 | 0 |
| 2024 | 67 | 0 |
| 2025 | 56 | 0 |
| 2026 | 49 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051454 | Aleutian Spacer SystemSummary page 2…ntation was provided which demonstrated that the subject Chesapeake Spinal System components ~ are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (K051454, K082698), Surgicraft Stalif System (K073109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitair… | 2005 |
| * | K082698 | Aleutian Ibf SystemSummary page 2…as provided which demonstrated that the subject Chesapeake Spinal System components ~ are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (K051454, K082698), Surgicraft Stalif System (K073109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (K08150… | 2009 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 2…he subject Chesapeake Spinal System components ~ are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (K051454, K082698), Surgicraft Stalif System (K073109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (K081501). 6. Comparison of the technologic… | 2008 |
| * | K062083 | Synfix -LRSummary page 2…al System components ~ are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (K051454, K082698), Surgicraft Stalif System (K073109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (K081501). 6. Comparison of the technological characteristics of the… | 2007 |
| * | K072253 | Synfix-LR SpacerSummary page 2…components ~ are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (K051454, K082698), Surgicraft Stalif System (K073109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (K081501). 6. Comparison of the technological characteristics of the device to… | 2007 |
| * | K083475 | Lucent MagnumSummary page 2…ally equivalent to the K2M Aleutian Interbody Spacer Systems (K051454, K082698), Surgicraft Stalif System (K073109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (K081501). 6. Comparison of the technological characteristics of the device to predicate and legatly mark… | 2009 |
| * | K081501 | Solitaire Anterior Spinal SystemSummary page 2…ian Interbody Spacer Systems (K051454, K082698), Surgicraft Stalif System (K073109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (K081501). 6. Comparison of the technological characteristics of the device to predicate and legatly marketed devices: There are no signi… | 2008 |
What descends from it? (450)
See all 4505 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 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, K111439 (K2m, Inc., 2011) has gone furthest, with 345 descendants of its own.
- 7 other devices also cite its predicate K051454.
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. 2010, 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?
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Chesapeake implants are intended for spinal fusion procedures in skeletally mature patients who have had six months of non-operative treatment. When used as intervertebral body fusion devices, the implants are indicated for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the…
Read the full statement (220 words)
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Chesapeake implants are intended for spinal fusion procedures in skeletally mature patients who have had six months of non-operative treatment.
When used as intervertebral body fusion devices, the implants are indicated 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 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft.
When used as vertebral body replacement devices the Chesapeake implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Chesapeake implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The interior of the spacer may be packed with allograft or autograft.
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/K092211 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092211: Chesapeake Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092211
Report an extraction error
Are you the manufacturer?
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