510(k) · Cleared
ClearedInstrument System for Endoscopic Spinal Surgery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Spine, LLC · HRX Arthroscope
Cleared on Aug 28, 2012 as substantially equivalent to K090132 (Hoogland Spine Products, GmbH, 2009) and 1 other predicate after a 102-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Aug 28, 2012
- Review
- 102 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K991794 (1999). 13 ancestors in all, the oldest K941967 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
- 4 generations backK021748 Endius Atavi SystemEndius, Inc. · 2002
- 3 generations backK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- 2 generations backK061246 Endoscopic Spine SystemArthro Kinetics, Inc. · 2006
- 1 generation backK090132 Maxmorespine Spinal SystemHoogland Spine Products, GmbH · 2009
- This deviceK121482 Instrument System for Endoscopic Spinal SurgeryTheken Spine, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K991794 | Endoscopic Spinal Access System | Endius, Inc. | 1999 | — |
| −4 | K021748 | Endius Atavi System | Endius, Inc. | 2002 | — |
| −3 | K053267 | Endius Atavi System | Endius, Inc. | 2006 | 1 |
| −2 | K061246 | Endoscopic Spine System | Arthro Kinetics, Inc. | 2006 | — |
| −1 | K090132 | Maxmorespine Spinal System | Hoogland Spine Products, GmbH | 2009 | — |
| 0 (this device) | K121482 | Instrument System for Endoscopic Spinal Surgery | Theken Spine, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K090132 | Maxmorespine Spinal SystemSummary page 1…HRLX, HAE Classification Panel: Orthopedic Predicate Device: maxMore Spinal Endoscopy System, Hoogland Spine Products (K090 132). THESSYS Multiscope System, Joimax (KOS51827) Device Description: The… | 2009 |
| * | K051827 | Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys… | 2005 |
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 13 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 13 ancestors has a recall of any class.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The Instrument System for Endoscopic Spinal Surgery is intended for use in spinal surgical procedures such as: arthroplasty, nucleotomy, discectomy, and foraminotomy. These manual surgical instruments are hand-held devices intended to manipulate tissue in spinal surgery.
The rongeurs are manually operated instruments indicated for cuffing or biting bone during surgery involving the spinal column.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121482: Instrument System for Endoscopic Spinal Surgery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121482
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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