510(k) · Cleared
Recalled · Class II · 2024Ksea Powershaver System S2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy · HRX Arthroscope
Cleared on Apr 2, 2003 after a 90-day review. The FDA summary names no predicate by number. 4 later devices descend from it. It has been recalled once.
- Decided
- Apr 2, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK030009 Ksea Powershaver System S2Karl Storz Endoscopy · 2003
- Descendant · cites it directly · 2 of its ownK061134 Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme · 2006
- Descendant · cites it directly · 1 of its ownK092977 Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme · 2010
- Descendant · 2 generations on · 0 of its ownK193608 EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG · 2021
- Descendant · cites it directly · 0 of its ownK060172 Rema Shaver BladesRema Medizintechnik GmbH. · 2006
Most influential descendants
Showing 4 of 4 · See all- K061134Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme · 2006 · cites it directly2descendants
- K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme · 2010 · cites it directly1descendant
- K193608EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG · 2021 · 2 generations on0descendants
- K060172Rema Shaver BladesRema Medizintechnik GmbH. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030009 | Ksea Powershaver System S2 | Karl Storz Endoscopy | 2003 | — |
| +1 | K061134 | Eberle Shaver System C2 and Shaver Blades | Efs Eberle Feinwerktechnische Systeme | 2006 | — |
| +1 | K092977 | Eberle Shaver System Accessories | Efs Eberle Feinwerktechnische Systeme | 2010 | — |
| +2 | K193608 | EBERLE Shaver System C3 and Accessories | Eberle GmbH & Co. KG | 2021 | — |
| +1 | K060172 | Rema Shaver Blades | Rema Medizintechnik GmbH. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2021 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2024 | Class II | Z-0526-2025 | Under Investigation by firm | Due to holes detected in the inner barrier system that may compromise the sterility of the affected products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061134 (Efs Eberle Feinwerktechnische Systeme, 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The Karl Storz Powershaver System S2 is intended to provide controlled cutting, shaving and abrading of bone and tissue during arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, wrist, hip, and temporal mandibular joint (TMJ) conducted by qualified surgeons.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030009: Ksea Powershaver System S2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030009
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