510(k) · Cleared
ClearedModification to Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System, Model 8130, 8131
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Cross Intl. · MQP Spinal Vertebral Body Replacement Device
Cleared on Jan 17, 2002 as substantially equivalent to K010989 (Interpore Cross Intl., 2001) after a 30-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jan 17, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010989 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010989 Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal, Model 8119…Interpore Cross Intl. · 2001
- This deviceK014145 Modification to Telescopic Plate Spacer Thoracolumbar (TPS-TL)…Interpore Cross Intl. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010989 | Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal, Model 8119, 8120, 8130… | Interpore Cross Intl. | 2001 | — |
| 0 (this device) | K014145 | Modification to Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System… | Interpore Cross Intl. | 2002 | — |
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 MQP? 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K010989 | Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal, Model 8119, 8120, 8130, 8131 | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K010989.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System implants are vertebral body replacement devices intended for use in the thoracic and/or thoracolumbar spine (T3 to L5). The TPS-TL Spinal System is indicated to replace a diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed…
Read the full statement (116 words)
The Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System implants are vertebral body replacement devices intended for use in the thoracic and/or thoracolumbar spine (T3 to L5). The TPS-TL Spinal System is indicated to replace a diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The TPS-TL Spinal System is also indicated for treating fractures of the thoracic and jumbar spine. The TPS-TL Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
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/K014145 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014145: Modification to Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System, Model 8130, 8131.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014145
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026