510(k) · Cleared
ClearedLOSPA IS TLIF & DLIF Cages
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 Mar 31, 2017 as substantially equivalent to K151408 (Corentec Co., Ltd., 2015) and 4 other predicates after a 64-day review. Its family tree reaches back 15 generations to 2001. 1 of the 158 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 31, 2017
- Review
- 64 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K003155 (2001). 157 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 158 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 2 generations backK120275 Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC · 2012
- 1 generation backK151408 LOSPA IS Spinal SystemCorentec Co., Ltd. · 2015
- This deviceK170243 LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd. · 2017
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 5 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 4 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 2 generations backK120275 Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC · 2012
- 1 generation backK151408 LOSPA IS Spinal SystemCorentec Co., Ltd. · 2015
- This deviceK170243 LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd. · 2017
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −5 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −4 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −2 | K120275 | Synthes Acis/Vertebral Spacer CR | Synthes (Usa), LLC | 2012 | — |
| −1 | K151408 | LOSPA IS Spinal System | Corentec Co., Ltd. | 2015 | — |
| 0 (this device) | 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 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 12 | 0 |
| 2004 | 22 | 0 |
| 2005 | 14 | 0 |
| 2006 | 5 | 0 |
| 2007 | 12 | 0 |
| 2008 | 26 | 1 |
| 2009 | 14 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2013 | 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.
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? (5)
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 |
|---|---|---|---|
| * | K151408 | LOSPA IS Spinal SystemSummary page 6…LOSPA IS Spinal Corentec Co. Primary Systems K151408 LOSPA IS Ltd. (PLIF/ALIF/ACIF) Spinal Systems… | 2015 |
| * | K110650 | Zyston Arc Interbody SpacerSummary page 6…(PLIF/ALIF/ACIF) Spinal Systems Biomet Spine Zyston Curve TLIF Cages K110650 Additional (Zimmer) Interbody Spacer K7 LLC K7… | 2011 |
| * | K133126 | K7 Lumbar SpacersSummary page 6…K110650 Additional (Zimmer) Interbody Spacer K7 LLC K7 Lumbar Spacers K133126 LOSPA IS Spinal Corentec Co.… | 2013 |
| * | K100175 | Clydesdale Spinal SystemSummary page 6…(PLIF/ALIF/ACIF) Spinal Systems CLYDESDALE Medtronic K100175 DLIF Cages Spinal System Additional… | 2010 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 6…Additional ORACLE Cage DePuy Synthes K072791 System The LOSPA IS Spinal Systems consisting of TLIF & DLIF Interbo… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 18 of the 157 ancestors have a recall of any class; 1 has a Class I recall.
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. 2017, 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/T-PLIF & ALIF & TLIF & DLIF Cages are indicated for use with autogenous bone graft as an intervertebral body fusion device 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.…
Read the full statement (122 words)
LOSPA IS PLIF/T-PLIF & ALIF & TLIF & DLIF Cages are indicated for use with autogenous bone graft as an intervertebral body fusion device 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170243: LOSPA IS TLIF & DLIF Cages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170243
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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