510(k) · Cleared
ClearedLOSPA IS Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corentec Co., Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 2, 2015 as substantially equivalent to K073470 (Stryker Spine, 2008) and 5 other predicates after a 129-day review. Its family tree reaches back 14 generations to 2001. 1 of the 117 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 2, 2015
- Review
- 129 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K003155 (2001). 115 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 117 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 backK120275 Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC · 2012
- This deviceK151408 LOSPA IS Spinal SystemCorentec Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK170243 LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd. · 2017
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 backK120275 Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC · 2012
- This deviceK151408 LOSPA IS Spinal SystemCorentec Co., Ltd. · 2015
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd. · 2017 · cites it directly0descendants
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 | K120275 | Synthes Acis/Vertebral Spacer CR | Synthes (Usa), LLC | 2012 | — |
| 0 (this device) | K151408 | LOSPA IS Spinal System | Corentec Co., Ltd. | 2015 | — |
| +1 | K170243 | LOSPA IS TLIF & DLIF Cages | Corentec Co., Ltd. | 2017 | — |
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 | 10 | 0 |
| 2004 | 19 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 14 | 1 |
| 2009 | 8 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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? (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 |
|---|---|---|---|
| * | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXXSummary page 7…tary 510(k) Number Manufacturer Predicate Type or Model Name AVS PL Peek Spacer K073470 Stryker Primary (O.I.C) K103111 FORZA… | 2008 |
| * | K103111 | Forza Spacer SystemSummary page 7…Model Name AVS PL Peek Spacer K073470 Stryker Primary (O.I.C) K103111 FORZA Spacer Orthofix Inc. Additional K122639 SynCage Evolution DepuySynthes… | 2011 |
| * | K122639 | Synthes Syncage Evolution SpacerSummary page 7…Stryker Primary (O.I.C) K103111 FORZA Spacer Orthofix Inc. Additional K122639 SynCage Evolution DepuySynthes Additional K042714 Fidji Zimmer… | 2013 |
| * | K042714 | Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Summary page 7…O.I.C) K103111 FORZA Spacer Orthofix Inc. Additional K122639 SynCage Evolution DepuySynthes Additional K042714 Fidji Zimmer Additional K120275 ACIS DePuySynthes… | 2004 |
| * | K120275 | Synthes Acis/Vertebral Spacer CRSummary page 7…tional K122639 SynCage Evolution DepuySynthes Additional K042714 Fidji Zimmer Additional K120275 ACIS DePuySynthes Additional K083311 CeSpace Aesculap… | 2012 |
| * | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion SystemSummary page 7…tional K042714 Fidji Zimmer Additional K120275 ACIS DePuySynthes Additional K083311 CeSpace Aesculap Additional The LOSPA IS PLIF Cages have a tapered leading edge similar to t… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170243 | LOSPA IS TLIF & DLIF Cages | 2017 | 0 |
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 14 of the 115 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170243 (Corentec Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 17 other devices also cite its predicate K073470.
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. 2015, 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?
LOSPA IS PLIF&ALIF Cages are indicated for use with autogenous bone graft as intervertebral body fusion devices at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous…
Read the full statement (201 words)
LOSPA IS PLIF&ALIF Cages are indicated for use with autogenous bone graft as intervertebral body fusion devices at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Patients should be skeletally mature and have had six months of non-operative treatment.
Devices are intended to be implanted via an open, posterior or anterior approach and used with autogenous bone and supplemental fixation.
LOSPA IS ACIF Cage is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.
Patients should have received at least six weeks of non-operative treatment prior to treatment with the device.
Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation.
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/K151408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151408: LOSPA IS 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/K151408
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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