510(k) · Cleared
ClearedOscar Orthosonics System for Cemented Arthroplasty Revision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.L. Mcintosh & Assoc., Inc. · JDX Instrument, Surgical, Sonic And Accessory/Attachment
Cleared on Aug 1, 1996 as substantially equivalent to K900003 (Advanced Osseous Technologies, 1990) after a 90-day review. Its family tree reaches back 1 generation to 1990. 8 later devices descend from it.
- Decided
- Aug 1, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- JDX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900003 (1990). 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK900003 System Ten Model 100 Surgical SystemAdvanced Osseous Technologies · 1990
- This deviceK961725 Oscar Orthosonics System for Cemented Arthroplasty RevisionC.L. Mcintosh & Assoc., Inc. · 1996
- Descendant · cites it directly · 7 of its ownK021502 Oscar, Model OE3000Orthosonics, Ltd. · 2002
- Descendant · cites it directly · 3 of its ownK051053 Oscar, Model OE3000DBOrthosonics, Ltd. · 2005
- Descendant · 2 generations on · 2 of its ownK063531 Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd. · 2007
- Descendant · 3 generations on · 1 of its ownK151101 Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK083830 Oscar Bone ResectorOrthosonics, Ltd. · 2009
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K021502Oscar, Model OE3000Orthosonics, Ltd. · 2002 · cites it directly7descendants
- K051053Oscar, Model OE3000DBOrthosonics, Ltd. · 2005 · cites it directly3descendants
- K063531Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd. · 2007 · 2 generations on2descendants
- K151101Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd. · 2015 · 3 generations on1descendant
- K083830Oscar Bone ResectorOrthosonics, Ltd. · 2009 · 2 generations on1descendant
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) | K961725 | Oscar Orthosonics System for Cemented Arthroplasty Revision | C.L. Mcintosh & Assoc., Inc. | 1996 | — |
| +1 | K021502 | Oscar, Model OE3000 | Orthosonics, Ltd. | 2002 | — |
| +1 | K051053 | Oscar, Model OE3000DB | Orthosonics, Ltd. | 2005 | — |
| +2 | K063531 | Series 3 Lotus Laparoscopic Ultrasound Surgery System | Sra Developments, Ltd. | 2007 | — |
| +3 | K151101 | Lotus Series 4 Ultrasonic Surgical System & Accessories | Sra Developments, Ltd. | 2015 | — |
| +2 | K083830 | Oscar Bone Resector | Orthosonics, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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), 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…TE DEVICES The OSCAR Orthosonics Ultrasonics Cement Removal System is substantially equivalent to the Advanced Osseous Technologies System 10 Model 100 Surgical System (K900003), and is similar to the Cooper Lasersonics CUSA System 200M (K864983). DEVICE DESCRIPTION The OSCAR Orthosonics Ultrasonic Ceme… | 1990 |
| † | K864983 | Cusa System 200 Macro-Dissector | 1987 |
What descends from it? (8)
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?
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 OSCAR Orthosonics System for Cemented Arthroplasty Revision is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.
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/K961725 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961725: Oscar Orthosonics System for Cemented Arthroplasty Revision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961725
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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