510(k) · Cleared

Cleared

Total Spinal Correction

K760649510(k) TraditionalCleared Oct 5, 197620-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

Depuy, Inc. · JDN Implant, Fixation Device, Spinal

Cleared on Oct 5, 1976 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Oct 5, 1976
Review: 20 days
Class: Class II
Product code: JDN
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK760649 Total Spinal CorrectionDepuy, Inc. · 1976
Descendant · cites it directly · 0 of its ownK191212 CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System…Medos International SARL · 2019

Most influential descendants

Showing 1 of 1 · See all

K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K760649	Total Spinal Correction	Depuy, Inc.	1976	—
+1	K191212	CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM…	Medos International SARL	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K760649, 1976–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JDN? 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

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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? (1)

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

Number	Device	Applicant	Decided	Descendants
K191212	CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…	Medos International SARL	2019	0

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, K191212 (Medos International SARL, 2019) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JDN devices

JDN Implant, Fixation Device, Spinal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDN

FDA has decided no JDN device since 2007.

Median 510(k) review, days · JDN

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

Recalls per year · JDN

No recall names JDN since 2007.

Adverse event reports per year · JDN

1in 2024

2007high 77 (2007) · low 0 (2025)2025

MAUDE reports naming product code JDN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	77
2008	—	50
2009	—	56
2010	—	5
2011	—	3
2012	—	8
2013	—	64
2014	—	17
2015	—	23
2016	—	2
2017	—	6
2018	—	2
2019	—	6
2020	—	6
2021	—	2
2022	—	16
2023	—	8
2024	—	1
2025	—	0
2026	—	—

https://510kreport.com/device/K760649 · printed Nov 6, 2026

Cite this page

510(k) Report. “K760649: Total Spinal Correction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760649

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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