510(k) Report

PMA · Approved

Recalled · Class II · 2026

Prodisc TM-C Total Disc Replacement

P070001PMAApproved Dec 17, 2007348-day reviewClass IIIRecalls 4

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

Centinel Spine, LLC · MJO Prosthesis, Intervertebral Disc

Approved on Dec 17, 2007 through premarket approval, which rests on the device’s own clinical evidence after a 348-day review. 5 later devices descend from it. It has been recalled 4 times.

Decided
Dec 17, 2007
Review
348 days
Class
Class III
Product code
MJO
Recalls
4

5 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2022: 1 descendant cleared2026: 2 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceP070001 Prodisc TM-C Total Disc ReplacementCentinel Spine, LLC · 2007
  2. Descendant · cites it directly · 4 of its ownK221848 prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC · 2022
  3. Descendant · 2 generations on · 1 of its ownK242869 prodisc® L InstrumentsCentinel Spine, LLC · 2024
  4. Descendant · 2 generations on · 0 of its ownK262639 BAGUERA® C Cervical Disc Surgical InstrumentsSpineart SA · 2026
  5. Descendant · 2 generations on · 0 of its ownK253392 Synergy Disc InstrumentsSynergy Spine Solutions, Inc. · 2026
  6. Descendant · 3 generations on · 0 of its ownK250554 prodisc® L InstrumentsCentinel Spine, LLC · 2025

Most influential descendants

Showing 5 of 5 · See all
  • K221848prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC · 2022 · cites it directly4descendants
  • K242869prodisc® L InstrumentsCentinel Spine, LLC · 2024 · 2 generations on1descendant
  • K262639BAGUERA® C Cervical Disc Surgical InstrumentsSpineart SA · 2026 · 2 generations on0descendants
  • K253392Synergy Disc InstrumentsSynergy Spine Solutions, Inc. · 2026 · 2 generations on0descendants
  • K250554prodisc® L InstrumentsCentinel Spine, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P070001Prodisc TM-C Total Disc ReplacementCentinel Spine, LLC2007—
+1K221848prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC2022—
+2K242869prodisc® L InstrumentsCentinel Spine, LLC2024—
+2K262639BAGUERA® C Cervical Disc Surgical InstrumentsSpineart SA2026—
+2K253392Synergy Disc InstrumentsSynergy Spine Solutions, Inc.2026—
+3K250554prodisc® L InstrumentsCentinel Spine, LLC2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202410
202510
202620
FIG. 1 — Lineage of P070001, 2007–2026Source: 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 PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MJO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K221848prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC20224

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 20, 2026Class IIZ-2050-2026Labeling mix-upsProduct labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Mar 20, 2026Class IIZ-2051-2026Labeling mix-upsProduct labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Dec 31, 2025Class IIZ-1426-2026Process controlProducts were mislabeled as the 6mm product but included the 5 mm product.
Mar 5, 2021Class IIZ-1406-2021Employee errorCentinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K221848 (Centinel Spine, LLC, 2022) has gone furthest, with 4 descendants of its own.

How does its category compare?

All MJO devices

MJO Prosthesis, Intervertebral Disc: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MJO

13in 2025

2007: 42008: 52009: 12010: 62011: 112012: 62013: 122014: 252015: 112016: 142017: 152018: 92019: 122020: 212021: 172022: 112023: 122024: 132025: 132026 (partial year): 14
2007high 25 (2014) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MJO

Too few MJO 510(k)s in any year since 2007 to give a median.

Recalls per year · MJO

6in 2007

2007: 62026 (partial year): 2
2007high 6 (2007) · low 0 (2008)2026

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

Adverse event reports per year · MJO

262in 2025

2007: 2782008: 1042009: 2832010: 1742011: 2512012: 3142013: 3712014: 3282015: 7242016: 1612017: 2772018: 3692019: 3802020: 3452021: 3082022: 2632023: 2782024: 3152025: 262
2007high 724 (2015) · low 104 (2008)2025

MAUDE reports naming product code MJO, 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
20074—6278
20085—0104
20091—0283
20106—0174
201111—0251
20126—0314
201312—0371
201425—0328
201511—0724
201614—0161
201715—0277
20189—0369
201912—0380
202021—0345
202117—0308
202211—0263
202312—0278
202413—0315
202513—0262
202614—2—

More from Centinel Spine, LLC

58 FDA decisions under this applicant name. See the company

  • K263159prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo InstrumentsCentinel Spine, LLC · 2026
  • P070001/S031prodisc® C NovaCentinel Spine, LLC · 2026
  • P070001/S030prodisc® CCentinel Spine, LLC · 2026
  • P070001/S025prodisc C SK and prodisc C VivoCentinel Spine, LLC · 2025
  • P050010/S027Prodisc LCentinel Spine, LLC · 2025

Recent decisions in MJO

The MJO category page

  • P250042/S002BAGUERA®C Cervical Disc ProsthesisSpineart USA, Inc. · 2026
  • P250028/S003Synergy DiscSynergy Spine Solutions, Inc. · 2026
  • P110009/S040Mobi-C® Cervical Disc Prosthesis for use at Two LevelsHighridge Medical, LLC · 2026
  • P110002/S040Mobi-C® Cervical Disc Prosthesis for use at One LevelHighridge Medical, LLC · 2026
  • P070001/S031prodisc® C NovaCentinel Spine, LLC · 2026

https://510kreport.com/device/P070001 · printed Nov 6, 2026

Cite this page

510(k) Report. “P070001: Prodisc TM-C Total Disc Replacement.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P070001

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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