510(k) · Cleared
ClearedStryker Cement Removal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · LZV System, Cement Removal Extraction
Cleared on Jul 15, 1996 after a 118-day review. The FDA summary names no predicate by number. 8 later devices descend from it.
- Decided
- Jul 15, 1996
- Review
- 118 days
- Class
- Class II
- Product code
- LZV
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK961101 Stryker Cement Removal SystemStryker Corp. · 1996
- Descendant · cites it directly · 7 of its ownK021502 Oscar, Model OE3000Orthosonics, Ltd. · 2002
- Descendant · 2 generations on · 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 · 3 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 · 2 generations on3descendants
- 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 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961101 | Stryker Cement Removal System | Stryker Corp. | 1996 | — |
| +1 | K021502 | Oscar, Model OE3000 | Orthosonics, Ltd. | 2002 | — |
| +2 | 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 | — |
| +3 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021502 | Oscar, Model OE3000 | 2002 | 7 |
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?
- Of its descendants, K021502 (Orthosonics, Ltd., 2002) has gone furthest, with 7 descendants of its own.
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 Stryker Cement Removal System (CRS) is indicated for use in revision hip arthroplasty to remove the old PMMA distal cement plug from the area between the distal tip of the primary implant and proximal to any bony restriction within the femoral canal.
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/K961101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961101: Stryker Cement Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961101
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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