510(k) · Cleared
ClearedIsola Twister Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acromed Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Mar 14, 1997 after an 86-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 14, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | ISOLA Twister Connector manufactured from implant grade stainless steel Named without a submission number | |
| * | — | other AcroMed Slotted Connectors Named without a submission number |
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.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spoadylolisthesis at the fifth lumbar - first sacral vertebral (LS-S1) joint utilizing atologous bone graft, having the device fixed or attached to the Jumbar and sacral spine and intended to be removed after solid fixsion is attained. The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacralfiliac screw fixation from T1…
Read the full statement (125 words)
The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spoadylolisthesis at the fifth lumbar - first sacral vertebral (LS-S1) joint utilizing atologous bone graft, having the device fixed or attached to the Jumbar and sacral spine and intended to be removed after solid fixsion is attained.
The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacralfiliac screw fixation from T1 to spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery.
As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.
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/K965046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K965046: Isola Twister Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965046
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026