510(k) · Cleared
ClearedEasy Rod
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 Jun 3, 1997 as substantially equivalent to K944737 (Acromed Corp., 1995) after an 81-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jun 3, 1997
- Review
- 81 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944737 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK944737 Isola Spine SystemAcromed Corp. · 1995
- This deviceK970950 Easy RodAcromed Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944737 | Isola Spine System | Acromed Corp. | 1995 | — |
| 0 (this device) | K970950 | Easy Rod | Acromed Corp. | 1997 | — |
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 |
|---|---|---|---|
| * | K944737 | Isola Spine SystemSummary page 1…nd are cut to the appropriate length during the surgical procedure. The Easy Rod is a variation of rods previously cleared for the ISOLA Spinal System under K884163 and K944737. The AcroMed Easy Rod is manufactured from implant grade (Grade 2 annealed) stainless steel conforming to ASTM F138 specificatio… | 1995 |
| * | — | Harrington System 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.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K944737.
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 Easy Rod is 2 variarion of the % inch diameter ISOLA rod of the ISOLA Spine System. This rod offers the surgeon casicr contourebility and casicr in-sit bending compared with cxisting ¥ inch diamcter ISOLA rods. The ISOLA System consists of two sub-systems: The Poswnor 1SOLA. sysmm and the Anterior ISOLA-System “The Easy Rod is intended to be used with the Posterior ISOLA System atthistime. The ISOLA implants, when used with pedicle screws, are…
Read the full statement (410 words)
The Easy Rod is 2 variarion of the % inch diameter ISOLA rod of the ISOLA Spine System. This rod offers the surgeon casicr contourebility and casicr in-sit bending compared with cxisting ¥ inch diamcter ISOLA rods. The ISOLA System consists of two sub-systems: The Poswnor 1SOLA. sysmm and the Anterior ISOLA-System “The Easy Rod is intended to be used with the Posterior ISOLA System atthistime.
The ISOLA implants, when used with pedicle screws, are intended for use in Grade 3 or 4 spondylolisthesis at L35-S1 utilizing anologous bone eraft, having the device fixed or attached to the lumbar and sacral spinc and intended w be removed after solid fusion is amained.
When not used with pedicle screws, the ISOLA System is intended for hook. wire, and/or sacral/iliac screw fixation fom the T1 to the ilium/sacrum. The non pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as :fiscogemc back pain with degencration of the disc confirmed by historv and radiographic studics), deformities (scoliosis, lordosis and hphos:s). twmor, fracture and previous failed surgery.
As a whole, the Posterior ISOLA spinal system is intended for T1-sacral fixation. Pedicle screw fixation is from L3-S1.
The Anterior ISOLA system is intended for nse in correcting scoliotic, lordetic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixetion bridge parallel to the long axis of the spine. The Anterior system is indicated in situations where loss of correction is ¢xpected, where severe scoliosis exists or where pelvic obliquity is present. Spinal levels for anterior instrumentation are from TS-1L4.
Properly used, the Posterior and Anterior ISOLA Systems will provids temporary stbilization as an adjunct to spinal bone grafting processes. Specific indications are:
Idiopathic scoliosis.
Neuramuscular scoliosis/kyphoscoliosis with associated paralysis or spacisticity.
Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
Spinal fractures (acute reduction of late deformity).
Degenerative disc disease (defined s discogenic back pain with degneration of the disc confirmed by history and radiographic studies).
Neaplastic discase,
Revision surpery.
The Anterior [SOLA system is also used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Indications for these scoliotic uses include:
Collapsing and unstable paralytic deformity.
Progressively increasing scoliosis.
Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
Inability to mainuain siting balance, necessitating the use of the hands.
Increasing pelvic obliquity coincident with back pain or loss of sifting balance.
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/K970950 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970950: Easy Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970950
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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