510(k) · Cleared
ClearedHOPKINS Telescopes for Arthroscopy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz SE & CO. KG · HRX Arthroscope
Cleared on Aug 26, 2026 as substantially equivalent to K202659 (Stryker, 2020) and 1 other predicate after a 250-day review. Its family tree reaches back 6 generations to 1983.
- Decided
- Aug 26, 2026
- Review
- 250 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K833587 (1983). 19 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 6 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 5 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 4 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 3 generations backK080560 Henke Sass Wolf of America ArthroscopeHenke Sass Wolf of America, Inc. · 2008
- 2 generations backK093677 Stryker ArthroscopeStryker Endoscopy · 2010
- 1 generation backK202659 Stryker ArthroscopeStryker · 2020
- This deviceK254103 HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −5 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −4 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −3 | K080560 | Henke Sass Wolf of America Arthroscope | Henke Sass Wolf of America, Inc. | 2008 | — |
| −2 | K093677 | Stryker Arthroscope | Stryker Endoscopy | 2010 | — |
| −1 | K202659 | Stryker Arthroscope | Stryker | 2020 | — |
| 0 (this device) | K254103 | HOPKINS Telescopes for Arthroscopy | Karl Storz SE & CO. KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K202659 | Stryker ArthroscopeSummary page 5…Classification Name: Arthroscope (21 CFR 888.1100) Regulatory Class: II Product Code: HRX Classification Orthopedic Panel: Predicate STRYKER Arthroscopes (K202659) Device(s): KS Arthroscopic Telescopes (K943052) Device The KARL STORZ HOPKINS Telescopes for Arthroscopy produ… | 2020 |
| * | K943052 | Arthroscopic TelescopesSummary page 5…latory Class: II Product Code: HRX Classification Orthopedic Panel: Predicate STRYKER Arthroscopes (K202659) Device(s): KS Arthroscopic Telescopes (K943052) Device The KARL STORZ HOPKINS Telescopes for Arthroscopy product family Description: includes HOPKINS Forward-Ob… | 1995 |
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 43 years and passes through 6 companies; a new generation was cleared every 7.3 years on median.
- None of the 19 ancestors has a recall.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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?
For 28208BA, 28300BA, 28305BA, 28719BA, 28731AWA, 28731BWA, 28731CWA:
The KARL STORZ HOPKINS Telescopes and HOPKINS Forward-Oblique Telescope are intended for use in visualization during arthroscopic surgical procedures in the hip, knee, shoulder, elbow, wrist, and ankle.
For 28731AE:
The KARL STORZ ENDOCAMELEON ARTHRO HOPKINS Telescope is intended for use in visualization during arthroscopic surgical procedures in the hip, knee, shoulder, elbow, wrist, and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254103: HOPKINS Telescopes for Arthroscopy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254103
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026