510(k) · Cleared
ClearedAutogenesis Automator 2000 Model Number SC2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Autogenesis, Inc. · JEC Component, Traction, Invasive
Cleared on May 20, 1998 as substantially equivalent to K905514 (Advanced Biosearch Assn., 1991) after a 30-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- May 20, 1998
- Review
- 30 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905514 (1991). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K013818Autogenesis Automator, Model M1000Autogenesis, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905514 | Autogenesis (TM) Automator | Advanced Biosearch Assn. | 1991 | — |
| 0 (this device) | K981423 | Autogenesis Automator 2000 Model Number SC2000 | Autogenesis, Inc. | 1998 | — |
| +1 | K013818 | Autogenesis Automator, Model M1000 | Autogenesis, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
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 JEC? 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 JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K905514 | Autogenesis (TM) AutomatorSummary page 1…tantially equivalent in terms of safety and effectiveness to the CF Automator. The predicate device received clearance in 1991 under 510(k) Premarket Notification Number K905514. Device Description: Distraction osteogenesis is the process by which our bodies are able to “grow” bone and soft tissues at a… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013818 | Autogenesis Automator, Model M1000 | 2001 | 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?
- Its one ancestor has no recall.
- Of its descendants, K013818 (Autogenesis, Inc., 2001) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Autogenesis™ Automator™2000, in conjunction with standard, commercially available circular and unilateral fixation devices, may be used to perform compression or distraction on long bones. The Automator™2000 may replace the CF Automator™ or manual distraction and compression devices where they are traditionally applied. Indications for such use include the following:
the correction of bony or soft tissue deformities,
limb lengthening by epiphayseal and metaphyseal distraction,
bone thickening and/or lengthening of amputated stumps,
fracture fixation (open or closed),
pseudoarthrosis or non-union of long bones,
correction of segmental bony or soft tissue defects.
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/K981423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981423: Autogenesis Automator 2000 Model Number SC2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981423
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026