510(k) · Cleared
ClearedOSCAR 3
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 Feb 19, 2010 as substantially equivalent to K051053 (Orthosonics, Ltd., 2005) and 1 other predicate after a 70-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Feb 19, 2010
- Review
- 70 days
- Class
- Class II
- Product code
- JDX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K900003 (1990). 10 ancestors in all, the oldest K895198 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK900003 System Ten Model 100 Surgical SystemAdvanced Osseous Technologies · 1990
- 4 generations backK961725 Oscar Orthosonics System for Cemented Arthroplasty RevisionC.L. Mcintosh & Assoc., Inc. · 1996
- 3 generations backK021502 Oscar, Model OE3000Orthosonics, Ltd. · 2002
- 2 generations backK051053 Oscar, Model OE3000DBOrthosonics, Ltd. · 2005
- 1 generation backK083830 Oscar Bone ResectorOrthosonics, Ltd. · 2009
- This deviceK093805 OSCAR 3Orthosonics, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K900003 | System Ten Model 100 Surgical System | Advanced Osseous Technologies | 1990 | — |
| −4 | K961725 | Oscar Orthosonics System for Cemented Arthroplasty Revision | C.L. Mcintosh & Assoc., Inc. | 1996 | — |
| −3 | K021502 | Oscar, Model OE3000 | Orthosonics, Ltd. | 2002 | — |
| −2 | K051053 | Oscar, Model OE3000DB | Orthosonics, Ltd. | 2005 | — |
| −1 | K083830 | Oscar Bone Resector | Orthosonics, Ltd. | 2009 | — |
| 0 (this device) | K093805 | OSCAR 3 | Orthosonics, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K051053 | Oscar, Model OE3000DBSummary page 1…ICES This premnarket notification will demonstrate that the OSCAR 3 is substantially equivalent to the brthosonics OSCAR OE3000DB cleared by FDA as K051053 and the Orthosonics OSCAR Bone Resector (K083830). C. DEVICE DESCRIPTION The OSCAR 3 system consists of a generator,… | 2005 |
| * | K083830 | Oscar Bone ResectorSummary page 1…monstrate that the OSCAR 3 is substantially equivalent to the brthosonics OSCAR OE3000DB cleared by FDA as K051053 and the Orthosonics OSCAR Bone Resector (K083830). C. DEVICE DESCRIPTION The OSCAR 3 system consists of a generator, 3 handsets, an optional trolley and a range… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 2 other devices also cite its predicate K051053.
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. 2010, this device’s year, is highlighted.
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 3 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/K093805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093805: OSCAR 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093805
Report an extraction error
Are you the manufacturer?
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