510(k) · Cleared
ClearedLotus Ultrasonic System for Cemented Implant Extraction (Uscix)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sra Developments, Ltd. · JDX Instrument, Surgical, Sonic And Accessory/Attachment
Cleared on Dec 19, 2007 as substantially equivalent to K051053 (Orthosonics, Ltd., 2005) after a 61-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Dec 19, 2007
- Review
- 61 days
- Class
- Class II
- Product code
- JDX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K900003 (1990). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK900003 System Ten Model 100 Surgical SystemAdvanced Osseous Technologies · 1990
- 3 generations backK961725 Oscar Orthosonics System for Cemented Arthroplasty RevisionC.L. Mcintosh & Assoc., Inc. · 1996
- 2 generations backK021502 Oscar, Model OE3000Orthosonics, Ltd. · 2002
- 1 generation backK051053 Oscar, Model OE3000DBOrthosonics, Ltd. · 2005
- This deviceK072961 Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)Sra Developments, Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900003 | System Ten Model 100 Surgical System | Advanced Osseous Technologies | 1990 | — |
| −3 | K961725 | Oscar Orthosonics System for Cemented Arthroplasty Revision | C.L. Mcintosh & Assoc., Inc. | 1996 | — |
| −2 | K021502 | Oscar, Model OE3000 | Orthosonics, Ltd. | 2002 | — |
| −1 | K051053 | Oscar, Model OE3000DB | Orthosonics, Ltd. | 2005 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K051053 | Oscar, Model OE3000DBSummary page 2…Ultrasonic System for Cemented Implant extraction System (USCIX) is substantially equivalent to the Orthosonics OSCAR OE3000DB cleared by FDA as K051053. C. DEVICE DESCRIPTION The USCIX consists of a power module which generates the ultrasonic energy and pro… | 2005 |
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 17 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 8 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. 2007, 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 LOTUS Ultrasonic System for Cemented Implant extraction System (USCIX) is indicated for the softening of bone cement to facilitate the removal of implants, including pedicle screws and other spinal implants, during revision surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072961: Lotus Ultrasonic System for Cemented Implant Extraction (Uscix).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072961
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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