510(k) · Cleared
ClearedAnatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 22, 2013 as substantially equivalent to K112444 (Medtronic Sofamor Danck USA, Inc., 2011) and 14 other predicates after a 254-day review. Its family tree reaches back 14 generations to 2001. 1 of the 398 devices in its family, counting itself, has a Class I recall. 281 later devices descend from it.
- Decided
- Mar 22, 2013
- Review
- 254 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 15
Its longest line of descent runs back 14 generations to K003155 (2001). 116 ancestors in all, the oldest K792352 (1979). 281 later devices descend from it, 8 citing it directly. 1 of the 398 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- This deviceK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- Descendant · cites it directly · 228 of its ownK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 2 generations on · 190 of its ownK152277 PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 3 generations on · 155 of its ownK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- Descendant · cites it directly · 130 of its ownK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 124 of its ownK133205 Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 4 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- This deviceK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
Showing 5 of 281 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 281 · See all- K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly228descendants
- K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 2 generations on190descendants
- K161379ELSA SpacersGlobus Medical, Inc. · 2016 · 3 generations on155descendants
- K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly130descendants
- K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014 · cites it directly124descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −4 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −3 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −1 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| 0 (this device) | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| +1 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +2 | K152277 | PIVOX (tm) Oblique Lateral Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +3 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
| +1 | K142559 | ELEVATE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K133205 | Capstone PTC Spinal System, Clydesdale PTC Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 11 | 0 |
| 2004 | 16 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 9 | 0 |
| 2008 | 14 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 10 | 0 |
| 2018 | 5 | 0 |
| 2019 | 16 | 0 |
| 2020 | 16 | 0 |
| 2021 | 27 | 1 |
| 2022 | 29 | 0 |
| 2023 | 29 | 0 |
| 2024 | 50 | 0 |
| 2025 | 46 | 0 |
| 2026 | 43 | 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.
1 device in this family has a Class I recall. 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (15)
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 |
|---|---|---|---|
| * | K112444 | Anatomic Peek Cervical Fusion System | 2011 |
| * | K100214 | Cornerstone PSR Cervical Interbody Fusion DeviceSummary page 9…ns such as: a. ANATOMIC PEEK Cervical Fusion System KI 12444 (SE 11/15/2011) b. CORNERSTONE® PSR Cervical Fusion System K100214 (SEO06/25/201 0).141 11264 (SE 10/12/2011) c. PEEK PREVAIL® Cervical Interbody Device K073285 (SE 05/15/… | 2010 |
| * | K111264 | Cornerstone (R) PSR Cervical Fusion System | 2011 |
| * | K073285 | Peek Prevail Cervical Interbody DeviceSummary page 9…NERSTONE® PSR Cervical Fusion System K100214 (SEO06/25/201 0).141 11264 (SE 10/12/2011) c. PEEK PREVAIL® Cervical Interbody Device K073285 (SE 05/15/2008), K094042 (SE 06/30/2010), KI 113252 (SE 01/17/2012), K030327(SE 02/26/2003) d. CAPSTONE®… | 2008 |
| * | K094042 | Peek Prevail Cervical Interbody DeviceSummary page 9…sion System K100214 (SEO06/25/201 0).141 11264 (SE 10/12/2011) c. PEEK PREVAIL® Cervical Interbody Device K073285 (SE 05/15/2008), K094042 (SE 06/30/2010), KI 113252 (SE 01/17/2012), K030327(SE 02/26/2003) d. CAPSTONE®)CONTROL Spinal System… | 2010 |
| * | K113252 | Peek Prevail Cervical Interbody DeviceSummary page 9…00214 (SEO06/25/201 0).141 11264 (SE 10/12/2011) c. PEEK PREVAIL® Cervical Interbody Device K073285 (SE 05/15/2008), K094042 (SE 06/30/2010), KI 113252 (SE 01/17/2012), K030327(SE 02/26/2003) d. CAPSTONE®)CONTROL Spinal System K 120368 (04/09… | 2012 |
| * | K030327 | Zephir Anterior Cervical SystemSummary page 9…0/12/2011) c. PEEK PREVAIL® Cervical Interbody Device K073285 (SE 05/15/2008), K094042 (SE 06/30/2010), KI 113252 (SE 01/17/2012), K030327(SE 02/26/2003) d. CAPSTONE®)CONTROL Spinal System K 120368 (04/09/2012) e. CLVDES… | 2003 |
| * | K120368 | Capstone Control Spinal SystemSummary page 9…285 (SE 05/15/2008), K094042 (SE 06/30/2010), KI 113252 (SE 01/17/2012), K030327(SE 02/26/2003) d. CAPSTONE®)CONTROL Spinal System K 120368 (04/09/2012) e. CLVDESDALE® Spinal System KI 13528 (SE 12/20/201l]). K1001 75 (SE 06/02/2010),… | 2012 |
| * | K113528 | Clydesdale (R) Spinal System | 2011 |
| * | K100175 | Clydesdale Spinal SystemSummary page 10…d. CAPSTONE®)CONTROL Spinal System K 120368 (04/09/2012) e. CLVDESDALE® Spinal System KI 13528 (SE 12/20/201l]). K1001 75 (SE 06/02/2010), K083026 (SE 12/29/2008) f. CRESCENT® Spinal System (PEEK) K094025 (SE 04/26/20 10)… | 2010 |
| * | K083026 | Clydesdale Spinal SystemSummary page 10…ROL Spinal System K 120368 (04/09/2012) e. CLVDESDALE® Spinal System KI 13528 (SE 12/20/201l]). K1001 75 (SE 06/02/2010), K083026 (SE 12/29/2008) f. CRESCENT® Spinal System (PEEK) K094025 (SE 04/26/20 10) g. SOVEREIGN® Spi… | 2008 |
| * | K094025 | Crescent Spinal SystemSummary page 10…ALE® Spinal System KI 13528 (SE 12/20/201l]). K1001 75 (SE 06/02/2010), K083026 (SE 12/29/2008) f. CRESCENT® Spinal System (PEEK) K094025 (SE 04/26/20 10) g. SOVEREIGN® Spinal System K091813 (SE 11/17/2009), KI 10063 (SE 10/04/2011) h. TELAM… | 2010 |
| * | K091813 | Intrepid Spinal SystemSummary page 10…/02/2010), K083026 (SE 12/29/2008) f. CRESCENT® Spinal System (PEEK) K094025 (SE 04/26/20 10) g. SOVEREIGN® Spinal System K091813 (SE 11/17/2009), KI 10063 (SE 10/04/2011) h. TELAMON® PEEK Spinal System Kl110562 (SE H1/09/201 1) IX. Dis… | 2009 |
| * | K110063 | Sovereign Spinal SystemSummary page 9…Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. The labeling that is being proposed has previously been cleared by FDA in submission K 110063 for SOVEREIGN® Spinal System Implants. All the subject devices within this bundled submission have the same fundamental technolog… | 2011 |
| * | K110562 | Telamon Peek Spinal SystemSummary page 10…4025 (SE 04/26/20 10) g. SOVEREIGN® Spinal System K091813 (SE 11/17/2009), KI 10063 (SE 10/04/2011) h. TELAMON® PEEK Spinal System Kl110562 (SE H1/09/201 1) IX. Discussion of Non-Clinical Testing: In accordance FDA Guidance "Establishing Safety and Compatibi… | 2011 |
What descends from it? (281)
See all 2818 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | 2015 | 228 |
| K142559 | ELEVATE Spinal System | 2015 | 130 |
| K133205 | Capstone PTC Spinal System, Clydesdale PTC Spinal System | 2014 | 124 |
| K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with… | 2017 | 109 |
| K172328 | SOVEREIGN™ Spinal System | 2017 | 30 |
| K171107 | CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System | 2017 | 8 |
| K133645 | Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter… | 2014 | 6 |
| K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System… | 2020 | 4 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 10 of the 116 ancestors have a recall of any class.
- Of its descendants, K150135 (Medtronic Sofamor Danek USA, Inc., 2015) has gone furthest, with 228 descendants of its own.
- 4 other devices also cite its predicate K112444.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The ANATOMIC PEEK CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic…
Read the full statement (987 words)
The ANATOMIC PEEK CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is to be used with any cleared supplemental fixation device for cervical. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach.
The CORNERSTONE® PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.
The PEEK PREVAILTM Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C'7-T I disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAILTM Cemvical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAILTM Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The CAPSTONE CONTROL TM Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to SI1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.
The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S51. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmned by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
The SOVEREIGN®'Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.
The SOVEREIGN®0 interbody system may be used as a stand-alone device or in conjunction with supplemental fixation.
When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.
The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous bone graft in patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to SI1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122037: Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122037
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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