510(k) · Cleared
Recalled · Class II · 2021Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy Device - Lumbar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gallini Medical Devices, Srl · HRX Arthroscope
Cleared on Dec 8, 2014 as substantially equivalent to K032473 (Stryker Instruments, 2003) after a 179-day review. Its family tree reaches back 2 generations to 1984. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Dec 8, 2014
- Review
- 179 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K844131 (1984). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK844131 NucleotomeMedical Instrument Development Laboratories, Inc. · 1984
- 1 generation backK032473 Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 2003 · Recalled
- This deviceK141557 Herniatome Percutaneous Disectomy Device - Cervical, Herniatome…Gallini Medical Devices, Srl · 2014
- Descendant · cites it directly · 0 of its ownK180315 DiskomBiopsybell S.R.L. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180315DiskomBiopsybell S.R.L. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844131 | Nucleotome | Medical Instrument Development Laboratories, Inc. | 1984 | — |
| −1 | K032473 | Dekompressor Percutaneous Discectomy Probe | Stryker Instruments | 2003 | 3 |
| 0 (this device) | K141557 | Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous… | Gallini Medical Devices, Srl | 2014 | — |
| +1 | K180315 | Diskom | Biopsybell S.R.L. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (1)
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 |
|---|---|---|---|
| * | K032473 | Dekompressor Percutaneous Discectomy ProbeSummary page 4…HRX III. PREDICATE DEVICE Predicate: Stryker Instruments, DekompressorTM Percutaneous Discectomy Probe, K032473, market clearance date November 7, 2003. No reference devices were used in this submission. IV.… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180315 | Diskom | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 17, 2021 | Class II | Z-0146-2022 | Other | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. |
| May 17, 2021 | Class II | Z-0145-2022 | Other | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. |
| May 17, 2021 | Class II | Z-0144-2022 | Other | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 18.9 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K180315 (Biopsybell S.R.L., 2018) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K032473.
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?
The Herniatome Percutaneous Discectomy Device is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141557: Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy Device - Lumbar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141557
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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