510(k) Report

510(k) · Cleared

Cleared

Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal, Model 8119, 8120, 8130, 8131

K010989510(k) TraditionalCleared Nov 7, 2001218-day reviewClass II21 CFR 888.3060

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

Interpore Cross Intl. · MQP Spinal Vertebral Body Replacement Device

Cleared on Nov 7, 2001 after a 218-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Nov 7, 2001
Review
218 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared200020052010201520202025
  1. This deviceK010989 Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal, Model 8119…Interpore Cross Intl. · 2001
  2. Descendant · cites it directly · 0 of its ownK020204 Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System, Models…Interpore Cross Intl. · 2002
  3. Descendant · cites it directly · 0 of its ownK014145 Modification to Telescopic Plate Spacer Thoracolumbar (TPS-TL)…Interpore Cross Intl. · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K020204Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System, Models 8123, 8124, 8132…Interpore Cross Intl. · 2002 · cites it directly0descendants
  • K014145Modification to Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System, Model…Interpore Cross Intl. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010989Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal, Model 8119, 8120, 8130…Interpore Cross Intl.2001—
+1K020204Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System, Models 8123…Interpore Cross Intl.2002—
+1K014145Modification to Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System…Interpore Cross Intl.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
FIG. 1 — Lineage of K010989, 2001–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), 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. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K020204Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System, Models 8123, 8124, 8132…Interpore Cross Intl.20020
K014145Modification to Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System, Model…Interpore Cross Intl.20020

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?

  • Of its descendants, K020204 (Interpore Cross Intl., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

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

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, 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
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

More from Interpore Cross Intl.

39 FDA decisions under this applicant name. See the company

  • K050861Peek CasInterpore Cross Intl. · 2005
  • K031399Intergro DBMInterpore Cross Intl. · 20051 recall
  • K041407Titanium Mesh ImplantInterpore Cross Intl. · 2004
  • K043229Modification to Altius Oct SystemInterpore Cross Intl. · 2004
  • K042798C-Tek C-Trun Anterior Cervical Plate SystemInterpore Cross Intl. · 2004

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K010989 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010989: Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal, Model 8119, 8120, 8130, 8131.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010989

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026