510(k) Report

510(k) · Cleared

Cleared

Cutting Edge Spine Interbody Fusion Device

K102957510(k) TraditionalCleared Apr 28, 2011205-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cutting Edge Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Apr 28, 2011 as substantially equivalent to K090707 (Meditech Advisors, LLC, 2009) and 3 other predicates after a 205-day review. Its family tree reaches back 1 generation to 1996. 93 later devices descend from it.

Decided
Apr 28, 2011
Review
205 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to P950002 (1996). 4 ancestors in all. 93 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2007: 1 other ancestor1999: 1 other ancestor2020: 8 descendants cleared2015: 1 descendant cleared2018: 5 descendants cleared2016: 2 descendants cleared2017: 4 descendants cleared2019: 5 descendants cleared2021: 5 descendants cleared2022: 8 descendants cleared2025: 15 descendants cleared2023: 14 descendants cleared2024: 12 descendants cleared2026: 14 descendants clearedP950002 · Bak Interbody Fusion System · Zimmer Spine, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 7 descendants3 generations forward: 12 descendants4 generations forward: 14 descendants5 generations forward: 24 descendants6 generations forward: 14 descendants7 generations forward: 12 descendants8 generations forward: 3 descendants9 generations forward: 1 descendant10 generations forward: 1 descendant P950002 · Bak Interbody Fusion System · Zimmer Spine, Inc. · 19960+5+10
  1. Root · 1 generation backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
  2. This deviceK102957 Cutting Edge Spine Interbody Fusion DeviceCutting Edge Spine, LLC · 2011
  3. Descendant · cites it directly · 92 of its ownK150321 EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2015
  4. Descendant · 2 generations on · 50 of its ownK153615 NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC · 2016
  5. Descendant · 3 generations on · 49 of its ownK170318 NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC · 2017
  6. Descendant · 4 generations on · 37 of its ownK192115 SABLE Expandable SpacerGlobus Medical, Inc. · 2020
  7. Descendant · 5 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022

Showing 5 of 93 descendants. See all descendants

Descendants cleared per year

2015: 12016: 22017: 42018: 52019: 52020: 82021: 52022: 82023: 142024: 122025: 152026: 14
2015high 15 (2025) · low 1 (2015)2026

Most influential descendants

Showing 5 of 93 · See all
  • K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2015 · cites it directly92descendants
  • K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC · 2016 · 2 generations on50descendants
  • K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC · 2017 · 3 generations on49descendants
  • K192115SABLE Expandable SpacerGlobus Medical, Inc. · 2020 · 4 generations on37descendants
  • K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 5 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P950002Bak Interbody Fusion SystemZimmer Spine, Inc.1996—
0 (this device)K102957Cutting Edge Spine Interbody Fusion DeviceCutting Edge Spine, LLC2011—
+1K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC2015—
+2K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC2016—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC2017—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.2020—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer…Globus Medical, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200710
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201620
201740
201850
201950
202080
202150
202280
2023140
2024120
2025150
2026140
FIG. 1 — Lineage of K102957, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MAX? 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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K090707Talos Intervertebral Body Fusion Device
Summary page 2
…Device (CES) is substantially equivalent to the following device: 510(k) Number Device Manufacturer K(090707 Tabos Intervertebral Body Fusion Device Meditech Advisors, LLC P960025 (PMA) Lumbar I/F Cage®…
Meditech Advisors, LLC2009—
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 2
…Device Manufacturer K(090707 Tabos Intervertebral Body Fusion Device Meditech Advisors, LLC P960025 (PMA) Lumbar I/F Cage® System DePuy Spine P950002 (PMA) BAK® Interbody Fusio…
Depuy Spine, Inc.1999—
*P950002Bak Interbody Fusion System
Summary page 2
…Tabos Intervertebral Body Fusion Device Meditech Advisors, LLC P960025 (PMA) Lumbar I/F Cage® System DePuy Spine P950002 (PMA) BAK® Interbody Fusion System Zimmer K071724 Lucent device…
Zimmer Spine, Inc.1996—
*K071724Lucent
Summary page 2
…) Lumbar I/F Cage® System DePuy Spine P950002 (PMA) BAK® Interbody Fusion System Zimmer K071724 Lucent device Spinal Elements 4. Description of the Device The CES device…
Spinal Elements, Inc.2007—

Also cleared against K090707: 4 other devices →

What descends from it? (93)

See all 93

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592
K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201
K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181
K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200
K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K150321 (Cutting Edge Spine, LLC, 2015) has gone furthest, with 92 descendants of its own.
  • 4 other devices also cite its predicate K090707.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

The Cutting Edge Spine Interbody Fusion Device (CES) is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L-2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The CES device is intended to be used with…

Read the full statement (144 words)

The Cutting Edge Spine Interbody Fusion Device (CES) is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L-2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The CES device is intended to be used with autologous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal, retroperitoneal or anterior approach. The CES-PLIF and CES-LIF are implanted in pairs, while the CES-TLIF, CES-CLIF and CES-RLIF devices may be implanted singly or in pairs in the lumbosacral spine. The CES device is intended to be used with supplemental fixation.

Indications for use as stated in the FDA summary.

Also cleared against K090707

4 other devices cite the same predicate.

  • K170297Tranquil Interbody SystemNexus Spine, LLC · 2017
  • K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC · 2017
  • K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C…Meditech Spine, LLC · 2015
  • K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI…Osteomed Implantes, Ltda · 2015

More from Cutting Edge Spine, LLC

11 FDA decisions under this applicant name. See the company

  • K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC · 2025
  • K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC · 2023
  • K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC · 2022
  • K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC · 2020
  • K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2020

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K102957 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102957: Cutting Edge Spine Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102957

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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