510(k) Report

510(k) · Cleared

Cleared

Biedermann Motech Universal Spinal System

K894184510(k) TraditionalCleared Apr 25, 1990313-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

Biedermann Motech GmbH · JDN Implant, Fixation Device, Spinal

Cleared on Apr 25, 1990 after a 313-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
Apr 25, 1990
Review
313 days
Class
Class II
Product code
JDN
Recalls
None
Predicates
0

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

Descendants, by year cleared 2019: 1 descendant cleared1996: 1 descendant cleared1990200020102020
  1. This deviceK894184 Biedermann Motech Universal Spinal SystemBiedermann Motech GmbH · 1990
  2. Descendant · cites it directly · 0 of its ownK191212 CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System…Medos International SARL · 2019
  3. Descendant · cites it directly · 0 of its ownK960107 DDS Spinal SystemEncore Orthopedics, Inc. · 1996

Most influential descendants

Showing 2 of 2 · See all
  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL · 2019 · cites it directly0descendants
  • K960107DDS Spinal SystemEncore Orthopedics, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K894184Biedermann Motech Universal Spinal SystemBiedermann Motech GmbH1990—
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM…Medos International SARL2019—
+1K960107DDS Spinal SystemEncore Orthopedics, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
201910
FIG. 1 — Lineage of K894184, 1990–2019Source: 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 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190
K960107DDS Spinal SystemEncore Orthopedics, Inc.19960

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

2007: 772008: 502009: 562010: 52011: 32012: 82013: 642014: 172015: 232016: 22017: 62018: 22019: 62020: 62021: 22022: 162023: 82024: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—077
20080—050
20090—056
20100—05
20110—03
20120—08
20130—064
20140—017
20150—023
20160—02
20170—06
20180—02
20190—06
20200—06
20210—02
20220—016
20230—08
20240—01
20250—00
20260—0—

More from Biedermann Motech GmbH

2 FDA decisions under this applicant name. See the company

  • K900138Motech Titanium Surgical MeshBiedermann Motech GmbH · 1990

Recent decisions in JDN

The JDN category page

  • K954856Cannulated Femoral NailSynthes (Usa) · 1996
  • K897141Slot Staples and Adaptor for Zielke Spinal FixatioStuart · 1990
  • K872715Universal Instrumentation (CD) for Spinal SurgeryRoseburg SA · 1987
  • K873977New C-D System for Spinal SurgerySofamor Co. · 1987
  • K760649Total Spinal CorrectionDepuy, Inc. · 1976

https://510kreport.com/device/K894184 · printed Nov 5, 2026

Cite this page

510(k) Report. “K894184: Biedermann Motech Universal Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K894184

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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