510(k) · Cleared
ClearedKarl Storz Magnifying Arthrosocpes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · HRX Arthroscope
Cleared on Oct 10, 1996 after a 195-day review. The FDA summary names no predicate by number. 61 later devices descend from it.
- Decided
- Oct 10, 1996
- Review
- 195 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
61 later devices descend from it, 1 citing it directly.
- This deviceK961228 Karl Storz Magnifying ArthrosocpesKARL STORZ Endoscopy-America, Inc. · 1996
- Descendant · cites it directly · 60 of its ownK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- Descendant · 2 generations on · 32 of its ownK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- Descendant · 3 generations on · 30 of its ownK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 21 of its ownK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- Descendant · 2 generations on · 21 of its ownK080560 Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc. · 2008
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K971253Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997 · cites it directly60descendants
- K043395Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005 · 2 generations on32descendants
- K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · 3 generations on30descendants
- K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008 · 3 generations on21descendants
- K080560Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc. · 2008 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961228 | Karl Storz Magnifying Arthrosocpes | KARL STORZ Endoscopy-America, Inc. | 1996 | — |
| +1 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| +2 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| +3 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| +3 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| +2 | K080560 | Henke Sass Wolf of America Arthroscope | Henke Sass Wolf of America, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 4 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (61)
See all 611 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | 1997 | 60 |
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, K971253 (Smith & Nephew, Inc., 1997) has gone furthest, with 60 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 KSEA magnifying arthroscopes and accessories are intended for use by qualified surgeons during arthroscopic procedures of the small and large joints. Specific arthroscope models are intended for arthroscopic procedures of the shoulder and knee; arthroscopic procedures of the elbow, ankle, wrist and jaw; and arthroscopic procedures for the shoulder, knee and illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint
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/K961228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961228: Karl Storz Magnifying Arthrosocpes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961228
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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