510(k) · Cleared
ClearedOscar, Model OE3000DB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosonics, Ltd. · JDX Instrument, Surgical, Sonic And Accessory/Attachment
Cleared on Jul 21, 2005 as substantially equivalent to K031280 (Biomet, Inc., 2003) and 2 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1990. 3 later devices descend from it.
- Decided
- Jul 21, 2005
- Review
- 87 days
- Class
- Class II
- Product code
- JDX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K900003 (1990). 7 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK900003 System Ten Model 100 Surgical SystemAdvanced Osseous Technologies · 1990
- 2 generations backK961725 Oscar Orthosonics System for Cemented Arthroplasty RevisionC.L. Mcintosh & Assoc., Inc. · 1996
- 1 generation backK021502 Oscar, Model OE3000Orthosonics, Ltd. · 2002
- This deviceK051053 Oscar, Model OE3000DBOrthosonics, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK083830 Oscar Bone ResectorOrthosonics, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK093805 OSCAR 3Orthosonics, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK072961 Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)Sra Developments, Ltd. · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900003 | System Ten Model 100 Surgical System | Advanced Osseous Technologies | 1990 | — |
| −2 | K961725 | Oscar Orthosonics System for Cemented Arthroplasty Revision | C.L. Mcintosh & Assoc., Inc. | 1996 | — |
| −1 | K021502 | Oscar, Model OE3000 | Orthosonics, Ltd. | 2002 | — |
| 0 (this device) | K051053 | Oscar, Model OE3000DB | Orthosonics, Ltd. | 2005 | — |
| +1 | K083830 | Oscar Bone Resector | Orthosonics, Ltd. | 2009 | — |
| +1 | K093805 | OSCAR 3 | Orthosonics, Ltd. | 2010 | — |
| +1 | K072961 | Lotus Ultrasonic System for Cemented Implant Extraction (Uscix) | Sra Developments, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K031280 | Ultra-Drive 3Summary page 1…tional, optional handset. B. LEGALLY MARKETED PREDICATE DEVICES The Orthosonics OSCAR OE3000DB is substantially equivalent to the Biomet Ultra-Drive® 3 (K031280), and the Orthosonics OSCAR (K961725, K021502). C. DEVICE DESCRIPTION The Orthosonics OSCAR OE3000DB consists of a pow… | 2003 |
| * | K961725 | Oscar Orthosonics System for Cemented Arthroplasty RevisionSummary page 1…April 25, 2005 A. REASON FOR SUBMISSION This 510(k) is being filed for two main reasons. Firstly, it is to cover improvements in the existing OSCAR (K961725, K021502) which includes a new digital tuning module and new single use probes. Secondly there is a change to the int… | 1996 |
| * | K021502 | Oscar, Model OE3000Summary page 1…25, 2005 A. REASON FOR SUBMISSION This 510(k) is being filed for two main reasons. Firstly, it is to cover improvements in the existing OSCAR (K961725, K021502) which includes a new digital tuning module and new single use probes. Secondly there is a change to the intended use… | 2002 |
What descends from it? (3)
3 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K083830 (Orthosonics, Ltd., 2009) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K031280.
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?
The Orthosonics OSCAR OE300ODB is intended to be used 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/K051053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051053: Oscar, Model OE3000DB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051053
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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