510(k) · Cleared
ClearedMetrx System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · HRX Arthroscope
Cleared on Nov 24, 2000 after a 65-day review. The FDA summary names no predicate by number. 1 of the 83 devices in its family, counting itself, has a Class I recall. 82 later devices descend from it.
- Decided
- Nov 24, 2000
- Review
- 65 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
82 later devices descend from it, 8 citing it directly. 1 of the 83 devices in this family, counting this one, has a Class I recall.
- This deviceK002931 Metrx SystemMedtronic Sofamor Danek, Inc. · 2000
- Descendant · cites it directly · 43 of its ownK022199 Endius Atavi SystemEndius, Inc. · 2002
- Descendant · 2 generations on · 42 of its ownK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
- Descendant · cites it directly · 30 of its ownK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- Descendant · cites it directly · 29 of its ownK043602 Quadrant Retractor SystemMedtronic Sofamor Danek · 2005
- Descendant · 3 generations on · 25 of its ownK061246 Endoscopic Spine SystemArthro Kinetics, Inc. · 2006
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K060973 Vycor Surgical Access Systems2 generations on · 2006
Most influential descendants
Showing 5 of 82 · See all- K022199Endius Atavi SystemEndius, Inc. · 2002 · cites it directly43descendants
- K053267Endius Atavi SystemEndius, Inc. · 2006 · 2 generations on42descendants
- K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · cites it directly30descendants
- K043602Quadrant Retractor SystemMedtronic Sofamor Danek · 2005 · cites it directly29descendants
- K061246Endoscopic Spine SystemArthro Kinetics, Inc. · 2006 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002931 | Metrx System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| +1 | K022199 | Endius Atavi System | Endius, Inc. | 2002 | — |
| +2 | K053267 | Endius Atavi System | Endius, Inc. | 2006 | 1 |
| +1 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| +1 | K043602 | Quadrant Retractor System | Medtronic Sofamor Danek | 2005 | — |
| +3 | K061246 | Endoscopic Spine System | Arthro Kinetics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 1 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 10 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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.
1 device in this family has a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (82)
See all 828 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022199 | Endius Atavi System | 2002 | 43 |
| K072879 | Innervue Diagnostic Scope System | 2008 | 30 |
| K043602 | Quadrant Retractor System | 2005 | 29 |
| K082293 | Surgview Integrated Visualization System | 2008 | 21 |
| K062038 | X-Sten Mild Tool Kit, Model MTK-0001 | 2006 | 14 |
| K181885 | Voyant System | 2018 | 2 |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | 2025 | 1 |
| K161878 | PORTAGE System | 2016 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060973Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K022199 (Endius, Inc., 2002) has gone furthest, with 43 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 METRxTM Microscope is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervial, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the METRx Microscope and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair…
Read the full statement (123 words)
The METRxTM Microscope is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervial, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the METRx Microscope and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. Other examples of generic surgical use of the METRx Microscope would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TM7).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K002931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002931: Metrx System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002931
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026