510(k) · Cleared
ClearedSystem Ten Model 100 Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Osseous Technologies · JDX Instrument, Surgical, Sonic And Accessory/Attachment
Cleared on Mar 16, 1990 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Mar 16, 1990
- Review
- 73 days
- Class
- Class II
- Product code
- JDX
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK900003 System Ten Model 100 Surgical SystemAdvanced Osseous Technologies · 1990
- Descendant · cites it directly · 8 of its ownK961725 Oscar Orthosonics System for Cemented Arthroplasty RevisionC.L. Mcintosh & Assoc., Inc. · 1996
- Descendant · 2 generations on · 7 of its ownK021502 Oscar, Model OE3000Orthosonics, Ltd. · 2002
- Descendant · cites it directly · 4 of its ownK031280 Ultra-Drive 3Biomet, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 3 of its ownK051053 Oscar, Model OE3000DBOrthosonics, Ltd. · 2005
- Descendant · 3 generations on · 2 of its ownK063531 Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd. · 2007
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K961725Oscar Orthosonics System for Cemented Arthroplasty RevisionC.L. Mcintosh & Assoc., Inc. · 1996 · cites it directly8descendants
- K021502Oscar, Model OE3000Orthosonics, Ltd. · 2002 · 2 generations on7descendants
- K031280Ultra-Drive 3Biomet, Inc. · 2003 · cites it directly4descendants
- K051053Oscar, Model OE3000DBOrthosonics, Ltd. · 2005 · 2 generations on3descendants
- K063531Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd. · 2007 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900003 | System Ten Model 100 Surgical System | Advanced Osseous Technologies | 1990 | — |
| +1 | K961725 | Oscar Orthosonics System for Cemented Arthroplasty Revision | C.L. Mcintosh & Assoc., Inc. | 1996 | — |
| +2 | K021502 | Oscar, Model OE3000 | Orthosonics, Ltd. | 2002 | — |
| +1 | K031280 | Ultra-Drive 3 | Biomet, Inc. | 2003 | 3 |
| +2 | K051053 | Oscar, Model OE3000DB | Orthosonics, Ltd. | 2005 | — |
| +3 | K063531 | Series 3 Lotus Laparoscopic Ultrasound Surgery System | Sra Developments, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
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 JDX? 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 JDX device
- #1 K201274 Ultrasonic Osteotomy Surgical Systemscore 3.3 · 9 generations · no Class I recall
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? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K961725 (C.L. Mcintosh & Assoc., Inc., 1996) has gone furthest, with 8 descendants of its own.
How does its category compare?
All JDX devicesJDX Instrument, Surgical, Sonic And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDX
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JDX
Too few JDX 510(k)s in any year since 2007 to give a median.
Recalls per year · JDX
No recall names JDX since 2007.
Adverse event reports per year · JDX
9in 2025
MAUDE reports naming product code JDX, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 8 |
| 2018 | 1 | — | 0 | 42 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K900003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900003: System Ten Model 100 Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900003
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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