510(k) · Cleared
ClearedPercutaneous Endoscopic Discectomy
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 8, 1996 after a 52-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Mar 8, 1996
- Review
- 52 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK960222 Percutaneous Endoscopic DiscectomyRichard Wolf Medical Instruments Corp. · 1996
- Descendant · cites it directly · 2 of its ownK994363 Instruments for Minimally Invasive Spinal Surgery (Miss)Richard Wolf Medical Instruments Corp. · 2000
- Descendant · 2 generations on · 1 of its ownK113362 Spinevu Endoscopic Spine System (Sess)Spine View, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK121548 Spinevu Endoscopic Spine System (Sess)Spine View, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See all- K994363Instruments for Minimally Invasive Spinal Surgery (Miss)Richard Wolf Medical Instruments Corp. · 2000 · cites it directly2descendants
- K113362Spinevu Endoscopic Spine System (Sess)Spine View, Inc. · 2012 · 2 generations on1descendant
- K121548Spinevu Endoscopic Spine System (Sess)Spine View, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960222 | Percutaneous Endoscopic Discectomy | Richard Wolf Medical Instruments Corp. | 1996 | — |
| +1 | K994363 | Instruments for Minimally Invasive Spinal Surgery (Miss) | Richard Wolf Medical Instruments Corp. | 2000 | — |
| +2 | K113362 | Spinevu Endoscopic Spine System (Sess) | Spine View, Inc. | 2012 | — |
| +2 | K121548 | Spinevu Endoscopic Spine System (Sess) | Spine View, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | 510(k) Arthroscopy instruments sold by Richard Wolf Named without a submission number | |
| * | — | Discectomy devices sold by AcuFlex Named without a submission number | |
| * | — | Discectomy devices sold by Smith + Nephew Named without a submission number | |
| * | — | Discectomy devices sold by Aesculap Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994363 | Instruments for Minimally Invasive Spinal Surgery (Miss) | 2000 | 2 |
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, K994363 (Richard Wolf Medical Instruments Corp., 2000) 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 instruments are used for Percutaneous Lumbar Disc Decompression. This involves partial or complete removal of human intervertebral disc hernias or degenerative diseases within the lumbar region. The goal is to decompress spinal structures like roots of nerves.
Performing procedures like the mentioned PDD (Percutaneous Disc Decompression) is restricted to trained surgeons.
The procedure is normally supported by the use of navigational systems (e.g. CT's, MRI, or Neuronavigation).
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/K960222 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960222: Percutaneous Endoscopic Discectomy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960222
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