510(k) · Cleared
ClearedOscar, Model OE3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosonics, Ltd. · LZV System, Cement Removal Extraction
Cleared on Jun 6, 2002 as substantially equivalent to K961725 (C.L. Mcintosh & Assoc., Inc., 1996) and 3 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1990. 7 later devices descend from it.
- Decided
- Jun 6, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- LZV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K900003 (1990). 5 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK900003 System Ten Model 100 Surgical SystemAdvanced Osseous Technologies · 1990
- 1 generation backK961725 Oscar Orthosonics System for Cemented Arthroplasty RevisionC.L. Mcintosh & Assoc., Inc. · 1996
- This deviceK021502 Oscar, Model OE3000Orthosonics, Ltd. · 2002
- Descendant · cites it directly · 3 of its ownK051053 Oscar, Model OE3000DBOrthosonics, Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK063531 Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd. · 2007
- Descendant · 2 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
- Descendant · 3 generations on · 0 of its ownK221102 LOTUS Series 4 Enhanced Shears, LOTUS Series 5Sra Developments, Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K051053Oscar, Model OE3000DBOrthosonics, Ltd. · 2005 · cites it directly3descendants
- K063531Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd. · 2007 · cites it directly2descendants
- K151101Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd. · 2015 · 2 generations on1descendant
- K083830Oscar Bone ResectorOrthosonics, Ltd. · 2009 · 2 generations on1descendant
- K221102LOTUS Series 4 Enhanced Shears, LOTUS Series 5Sra Developments, Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900003 | System Ten Model 100 Surgical System | Advanced Osseous Technologies | 1990 | — |
| −1 | K961725 | Oscar Orthosonics System for Cemented Arthroplasty Revision | C.L. Mcintosh & Assoc., Inc. | 1996 | — |
| 0 (this device) | K021502 | Oscar, Model OE3000 | Orthosonics, Ltd. | 2002 | — |
| +1 | K051053 | Oscar, Model OE3000DB | Orthosonics, Ltd. | 2005 | — |
| +1 | K063531 | Series 3 Lotus Laparoscopic Ultrasound Surgery System | Sra Developments, Ltd. | 2007 | — |
| +2 | K151101 | Lotus Series 4 Ultrasonic Surgical System & Accessories | Sra Developments, Ltd. | 2015 | — |
| +2 | K083830 | Oscar Bone Resector | Orthosonics, Ltd. | 2009 | — |
| +3 | K221102 | LOTUS Series 4 Enhanced Shears, LOTUS Series 5 | Sra Developments, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LZV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K961725 | Oscar Orthosonics System for Cemented Arthroplasty RevisionSummary page 1…obviously the currently marketed version of the Orthosonics OSCAR System for Cemented Arthroplasty Revision will serve as one predicate device (K961725). The laparoscope and optical coupler are currently marketed devices from Precision Optics of Gardner, MA. The… | 1996 |
| * | K914084 | EndoscopesSummary page 1…1725). The laparoscope and optical coupler are currently marketed devices from Precision Optics of Gardner, MA. These devices were cleared as K914084 on January 22, 1992 and K903458 on October 19, 1990. In addition, the Cement RemovaVExtraction System manufactured by… | 1992 |
| * | K903458 | Precision Optics Image CouplerSummary page 1…and optical coupler are currently marketed devices from Precision Optics of Gardner, MA. These devices were cleared as K914084 on January 22, 1992 and K903458 on October 19, 1990. In addition, the Cement RemovaVExtraction System manufactured by Stryker Instruments (K96… | 1990 |
| * | K961101 | Stryker Cement Removal SystemSummary page 1…K914084 on January 22, 1992 and K903458 on October 19, 1990. In addition, the Cement RemovaVExtraction System manufactured by Stryker Instruments (K961101) includes an accessory that in terms of hardware and function is very similar to the impact hammer accessory th… | 1996 |
What descends from it? (7)
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K051053 (Orthosonics, Ltd., 2005) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K961725.
How does its category compare?
All LZV devicesLZV System, Cement Removal Extraction: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZV
FDA has decided no LZV device since 2007.
Median 510(k) review, days · LZV
Too few LZV 510(k)s in any year since 2007 to give a median.
Recalls per year · LZV
No recall names LZV since 2007.
Adverse event reports per year · LZV
1in 2018
MAUDE reports naming product code LZV, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OE3000 is intended to assist in the removal of polymethylmethacrylate (PMMA)
bone cement during arthroplasty revision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021502: Oscar, Model OE3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021502
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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