510(k) · Cleared
Recalled · Class II · 2019Ultra-Drive 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDX Instrument, Surgical, Sonic And Accessory/Attachment
Cleared on Sep 22, 2003 as substantially equivalent to K900003 (Advanced Osseous Technologies, 1990) after a 153-day review. Its family tree reaches back 1 generation to 1990. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 22, 2003
- Review
- 153 days
- Class
- Class II
- Product code
- JDX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900003 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK900003 System Ten Model 100 Surgical SystemAdvanced Osseous Technologies · 1990
- This deviceK031280 Ultra-Drive 3Biomet, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK051053 Oscar, Model OE3000DBOrthosonics, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK083830 Oscar Bone ResectorOrthosonics, Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK093805 OSCAR 3Orthosonics, Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK072961 Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)Sra Developments, Ltd. · 2007
Most influential descendants
Showing 4 of 4 · See all- K051053Oscar, Model OE3000DBOrthosonics, Ltd. · 2005 · cites it directly3descendants
- K083830Oscar Bone ResectorOrthosonics, Ltd. · 2009 · cites it directly1descendant
- K093805OSCAR 3Orthosonics, Ltd. · 2010 · 2 generations on0descendants
- K072961Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)Sra Developments, Ltd. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900003 | System Ten Model 100 Surgical System | Advanced Osseous Technologies | 1990 | — |
| 0 (this device) | K031280 | Ultra-Drive 3 | Biomet, Inc. | 2003 | — |
| +1 | K051053 | Oscar, Model OE3000DB | Orthosonics, Ltd. | 2005 | — |
| +1 | K083830 | Oscar Bone Resector | Orthosonics, Ltd. | 2009 | — |
| +2 | K093805 | OSCAR 3 | Orthosonics, Ltd. | 2010 | — |
| +2 | K072961 | Lotus Ultrasonic System for Cemented Implant Extraction (Uscix) | Sra Developments, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 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? (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 |
|---|---|---|---|
| * | K900003 | System Ten Model 100 Surgical SystemSummary page 1…tial Equivalence Is Claimed: The Ultra- Drive@3 system is substantially equivalent to the System 10, Model 100 Surgical System for Orthopedic Use, cleared through 510(k) K900003. Device Description: The Ultra-Drive@3 consists of a control console, a footswitch, a handpiece with associated cables and conne… | 1990 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2019 | Class II | Z-1963-2019 | Under Investigation by firm | The products do not have sufficient data to support the labeled shelf life of 10 years. |
| Jun 4, 2019 | Class II | Z-1962-2019 | Under Investigation by firm | The products do not have sufficient data to support the labeled shelf life of 10 years. |
| Apr 18, 2012 | Not classified | Z-1521-2012 | Process design | Incorrect product picture label was on the product box. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
Cutting and removal of bone and acrylic bone cement in orthopedic applications
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031280: Ultra-Drive 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031280
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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