510(k) · Cleared
ClearedOsi Q System Arthroscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopedic Sciences, Inc. · HRX Arthroscope
Cleared on Feb 26, 2014 as substantially equivalent to K091398 (Orthopedic Sciences, Inc., 2009) and 1 other predicate after a 154-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Feb 26, 2014
- Review
- 154 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992782 (1999). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK992782 Nuvasive Spinal Arthroscope, Models 0, 30 and 70 DegreesNuvasive, Inc. · 1999
- This deviceK133018 Osi Q System ArthroscopesOrthopedic Sciences, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992782 | Nuvasive Spinal Arthroscope, Models 0, 30 and 70 Degrees | Nuvasive, Inc. | 1999 | — |
| 0 (this device) | K133018 | Osi Q System Arthroscopes | Orthopedic Sciences, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K091398 | ArthroscopeSummary page 2…parts of the arthroscope are the objective window (sapphire), eutectic solder, and USP Class VI epoxy, and are the same materials used in the predicate 051 Arthroscopes (K091 398). The visualization sheaths are made from 316 stainless steel. Arthroscopes are provided non-sterile and are reusable. Visualiza… | 2009 |
| * | K992782 | Nuvasive Spinal Arthroscope, Models 0, 30 and 70 DegreesSummary page 2…principles to the following legally marketed predicate devices: Orthopedic Sciences, Inc., Arthroscope, K091398, and NuVasive, Inc., Spinal Arthroscope, K992782. A summary of the indications for use and the technological characteristics of the subject device and the predicate devices is p… | 1999 |
| † | K931202 | Sterilization Wrap-Sterisheet | 1993 |
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?
- None of the 2 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. 2014, 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?
OSI Q System Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wrist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint. Hip Diagnostic procedures may include: Staging of avascular…
Read the full statement (115 words)
OSI Q System Arthroscopes of appropriate size and length are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the hip, shoulder, knee, elbow, wrist, and ankle, and also to provide illumination and visualization during open and closed arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the joint.
Hip Diagnostic procedures may include:
Staging of avascular necrosis
Chondral injuries
Joint sepsis
Synovial chondomatosis
Unresolved hip pain
Labral tears
OSI Q System Arthroscopes of appropriate size and length also are indicated for visualization and performance of arthroscopic surgical procedures on various structures of the spine, including nerve roots, foramina, intervertebral discs and the surrounding spinal structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133018: Osi Q System Arthroscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133018
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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