510(k) · Cleared
ClearedInstruments for Minimally Invasive Spinal Surgery (Miss)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · HRX Arthroscope
Cleared on Mar 6, 2000 as substantially equivalent to K973405 (Richard Wolf Medical Instruments Corp., 1998) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Mar 6, 2000
- Review
- 70 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960222 (1996). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK960222 Percutaneous Endoscopic DiscectomyRichard Wolf Medical Instruments Corp. · 1996
- This deviceK994363 Instruments for Minimally Invasive Spinal Surgery (Miss)Richard Wolf Medical Instruments Corp. · 2000
- Descendant · cites it directly · 1 of its ownK113362 Spinevu Endoscopic Spine System (Sess)Spine View, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK121548 Spinevu Endoscopic Spine System (Sess)Spine View, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960222 | Percutaneous Endoscopic Discectomy | Richard Wolf Medical Instruments Corp. | 1996 | — |
| 0 (this device) | K994363 | Instruments for Minimally Invasive Spinal Surgery (Miss) | Richard Wolf Medical Instruments Corp. | 2000 | — |
| +1 | K113362 | Spinevu Endoscopic Spine System (Sess) | Spine View, Inc. | 2012 | — |
| +1 | K121548 | Spinevu Endoscopic Spine System (Sess) | Spine View, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K973405 | Yeung Endoscopic Spine SystemSummary page 1…Arthroscope and Accessories Information on devices to which substantial equivalence is clalmed | : 0 4-] 510(k) Number Trade or proprietary or model name Manufacturer 1 K973405 1 Yeung Endoscopic Spine System 1 Richard Wolf 2 K960222 2 Instruments for Percutane Discetomy 2 Richard Wolf 3 3 Endoscopic Spin… | 1998 |
| * | K960222 | Percutaneous Endoscopic DiscectomySummary page 1…ich substantial equivalence is clalmed | : 0 4-] 510(k) Number Trade or proprietary or model name Manufacturer 1 K973405 1 Yeung Endoscopic Spine System 1 Richard Wolf 2 K960222 2 Instruments for Percutane Discetomy 2 Richard Wolf 3 3 Endoscopic Spine Instruments 3 Sofamor Danek 4 Miaspas Mini ALIF Instrum… | 1996 |
| * | — | Endoscopic Spine Instruments Named without a submission number | |
| * | — | Miaspas Mini ALIF Instrument Set for Fusion Named without a submission number |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 MISS instrument set is designed for transthoracic and transabdominal approaches to the spine. Hand instruments, such as osteotome, elevator, hook probe, spoon, curette, punch, compunction tube with obturator, and plug applicator are used for endoscopically controlled dissection, exploration, and manipulation of tissue through natural or surgically created passages. Rongeurs and punches are used under endoscopic control, to grasp, manipulate, and cut…
Read the full statement (123 words)
The MISS instrument set is designed for transthoracic and transabdominal approaches to the spine.
Hand instruments, such as osteotome, elevator, hook probe, spoon, curette, punch, compunction tube with obturator, and plug applicator are used for endoscopically controlled dissection, exploration, and manipulation of tissue through natural or surgically created passages.
Rongeurs and punches are used under endoscopic control, to grasp, manipulate, and cut, as well as for the dissection and biopsy of tissue, organs, or foreign bodies.
Suction irrigation punches are used for endoscopically controlled punching and removal of tissue through natural or surgically created passages.
For examination, diagnosis, and / or therapy by personnel trained and qualified in connection with endoscopically used accessories in various medical disciplines, such as orthopedic and spinal surgery.
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/K994363 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994363: Instruments for Minimally Invasive Spinal Surgery (Miss).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994363
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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