510(k) · Cleared
Recalled · Class II · 2021Chesapeake Stabilization 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 May 7, 2015 as substantially equivalent to K092211 (K2m, Inc., 2010) and 5 other predicates after a 245-day review. Its family tree reaches back 15 generations to 1984. 7 later devices descend from it. It has been recalled once.
- Decided
- May 7, 2015
- Review
- 245 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 15 generations to K841189 (1984). 131 ancestors in all, the oldest K792352 (1979). 7 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 2 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 1 generation backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- This deviceK142487 Chesapeake Stabilization SystemK2m, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK151481 Sahara Stabilization SystemK2m, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK201585 Monterey AL Interbody SystemStryker Corporation · 2020 · Recalled
- Descendant · 3 generations on · 1 of its ownK250072 CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL…Stryker Spine · 2023
- Descendant · 2 generations on · 0 of its ownK262061 Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium®…Stryker Spine · 2026
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 5 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 4 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 3 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 2 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 1 generation backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- This deviceK142487 Chesapeake Stabilization SystemK2m, Inc. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K151481Sahara Stabilization SystemK2m, Inc. · 2015 · cites it directly5descendants
- K201585Monterey AL Interbody SystemStryker Corporation · 2020 · 2 generations on4descendants
- K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc. · 2025 · 3 generations on1descendant
- K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine · 2023 · cites it directly1descendant
- K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −5 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −4 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −3 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| −2 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| −1 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| 0 (this device) | K142487 | Chesapeake Stabilization System | K2m, Inc. | 2015 | — |
| +1 | K151481 | Sahara Stabilization System | K2m, Inc. | 2015 | — |
| +2 | K201585 | Monterey AL Interbody System | Stryker Corporation | 2020 | 4 |
| +3 | K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025 | — |
| +1 | K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved… | Stryker Spine | 2023 | — |
| +2 | K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved… | Stryker Spine | 2026 | — |
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 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 19 | 0 |
| 2005 | 9 | 0 |
| 2006 | 6 | 0 |
| 2007 | 9 | 0 |
| 2008 | 17 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 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 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 4…on Name(s): Intervertebral Body Fusion Device with Integrated Fixation (21 CFR 888.3080, Product Code OVD, OVE) Predicate Device(s) Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K111439, K133494) K2M Aleutian (K082698, K133614) NuVasive Brigade (K123045) Device Des… | 2010 |
| * | K111439 | Chesapeake (Cervical Components)Summary page 4…th Integrated Fixation (21 CFR 888.3080, Product Code OVD, OVE) Predicate Device(s) Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K111439, K133494) K2M Aleutian (K082698, K133614) NuVasive Brigade (K123045) Device Description The spacers are manufactured from Medic… | 2011 |
| * | K133494 | Chesapeake Spinal SystemSummary page 4…ated Fixation (21 CFR 888.3080, Product Code OVD, OVE) Predicate Device(s) Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K111439, K133494) K2M Aleutian (K082698, K133614) NuVasive Brigade (K123045) Device Description The spacers are manufactured from Medical Grade… | 2014 |
| * | K082698 | Aleutian Ibf SystemSummary page 4…88.3080, Product Code OVD, OVE) Predicate Device(s) Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K111439, K133494) K2M Aleutian (K082698, K133614) NuVasive Brigade (K123045) Device Description The spacers are manufactured from Medical Grade PEEK (Polyetheretherket… | 2009 |
| * | K133614 | Aleutian Ibf SystemSummary page 4…Product Code OVD, OVE) Predicate Device(s) Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K111439, K133494) K2M Aleutian (K082698, K133614) NuVasive Brigade (K123045) Device Description The spacers are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTI… | 2014 |
| * | K123045 | Brigade Standalone SystemSummary page 4…redicate Device(s) Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K111439, K133494) K2M Aleutian (K082698, K133614) NuVasive Brigade (K123045) Device Description The spacers are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (Invibio™) per ISO… | 2013 |
What descends from it? (7)
3 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 |
|---|---|---|---|---|
| Sep 8, 2021 | Class II | Z-0104-2022 | Process control | Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 15 of the 131 ancestors have a recall of any class.
- Of its descendants, K151481 (K2m, Inc., 2015) has gone furthest, with 5 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. 2015, 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 Stabilization System 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…
Read the full statement (272 words)
When used as a cervical intervertebral body fusion device, the CHESAPEAKE Stabilization System 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 Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Lumbar IBF 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 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 hyperlordotic lumbar implants (i.e., > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Chesapeake Stabilization System implants (i.e., < 15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screws for the 2-screw and 3-screw implants, respectively).
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/K142487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142487: Chesapeake Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142487
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