510(k) · Cleared
Recalled · Class II · 2021Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neurosurgery · JXG Shunt, Central Nervous System And Components
Cleared on Nov 20, 2008 as substantially equivalent to K042465 (Medtronic Neurosurgery, 2004) and 1 other predicate after a 35-day review. Its family tree reaches back 7 generations to 1995. It has been recalled once.
- Decided
- Nov 20, 2008
- Review
- 35 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K944222 (1995). 14 ancestors in all, the oldest K831678 (1983). No later device cites it as a predicate yet.
- Root · 7 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 6 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- 5 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 4 generations backK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
- 3 generations backK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
- 2 generations backK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · Recalled
- 1 generation backK082127 Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635Medtronic Neurosurgery · 2008 · Recalled
- This deviceK083076 Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt…Medtronic Neurosurgery · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −6 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −5 | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −4 | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | Medtronic PS Medical | 2002 | — |
| −3 | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without… | Medtronic Neurosurgery | 2004 | 2 |
| −2 | K042465 | PS Medical Strata II Valve | Medtronic Neurosurgery | 2004 | 4 |
| −1 | K082127 | Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635 | Medtronic Neurosurgery | 2008 | 1 |
| 0 (this device) | K083076 | Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model… | Medtronic Neurosurgery | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 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 JXG? 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 JXG device
- #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 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 |
|---|---|---|---|
| * | K042465 | PS Medical Strata II ValveSummary page 1…dtronic PS Medical Strata II Valves and Shunt Assemblies with and without BioGlide (K042465) * PS Medical Strata NSC Burr Hole Valves and… | 2004 |
| * | K082127 | Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635Summary page 1…BioGlide (K042465) * PS Medical Strata NSC Burr Hole Valves and Shunt Assemblies (K082127) Description: The PS Medical®5 Strata® Burr Hole Valve is an adjustable valve designed for non-invasive pressure flow adjustment… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2021 | Class II | Z-1116-2021 | Process control | Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 14 ancestors have a recall of any class.
- 5 other devices also cite its predicate K042465.
How does its category compare?
All JXG devicesJXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JXG
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
MAUDE reports naming product code JXG, 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 | 3 | 184 | 0 | 649 |
| 2008 | 6 | 60 | 1 | 630 |
| 2009 | 5 | 106 | 30 | 629 |
| 2010 | 3 | 30 | 0 | 812 |
| 2011 | 7 | 136 | 5 | 787 |
| 2012 | 3 | 78 | 1 | 977 |
| 2013 | 3 | 108 | 14 | 1,004 |
| 2014 | 0 | — | 6 | 1,251 |
| 2015 | 6 | 276 | 0 | 984 |
| 2016 | 6 | 143 | 0 | 1,091 |
| 2017 | 7 | 90 | 1 | 1,335 |
| 2018 | 6 | 102 | 0 | 1,484 |
| 2019 | 4 | 101 | 0 | 1,295 |
| 2020 | 2 | — | 8 | 1,206 |
| 2021 | 1 | — | 0 | 1,467 |
| 2022 | 4 | 101 | 0 | 1,329 |
| 2023 | 5 | 134 | 2 | 1,221 |
| 2024 | 3 | 90 | 3 | 1,214 |
| 2025 | 8 | 255 | 0 | 1,198 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Strata Burr Hole valve is a shunt component designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The Strata Burr Hole valve allows the physician to non-invasively adjust the pressure/ flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083076: Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083076
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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