510(k) · Cleared
ClearedIsola Pediatric Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acromed Corp. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Nov 27, 1996 after a 118-day review. The FDA summary names its predicate without a number. 1 of the 588 devices in its family, counting itself, has a Class I recall. 587 later devices descend from it.
- Decided
- Nov 27, 1996
- Review
- 118 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
587 later devices descend from it, 5 citing it directly. 1 of the 588 devices in this family, counting this one, has a Class I recall.
- This deviceK962984 Isola Pediatric ComponentsAcromed Corp. · 1996
- Descendant · cites it directly · 582 of its ownK071668 Orthobiom Spinal SystemParadigm Spine · 2008
- Descendant · 2 generations on · 581 of its ownK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · 3 generations on · 269 of its ownK110070 TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011
- Descendant · 3 generations on · 261 of its ownK111457 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011
- Descendant · 3 generations on · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
Showing 5 of 587 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 587 · See all- K071668Orthobiom Spinal SystemParadigm Spine · 2008 · cites it directly582descendants
- K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on581descendants
- K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 3 generations on269descendants
- K111457CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011 · 3 generations on261descendants
- K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · 3 generations on260descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962984 | Isola Pediatric Components | Acromed Corp. | 1996 | — |
| +1 | K071668 | Orthobiom Spinal System | Paradigm Spine | 2008 | — |
| +2 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +3 | K110070 | TSRH Spinal System | Medtronic Sofamor Danck USA, Inc. | 2011 | — |
| +3 | K111457 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2011 | — |
| +3 | K113395 | Revere 4.5 Stabilization System | Globus Medical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 15 | 0 |
| 2013 | 24 | 0 |
| 2014 | 32 | 0 |
| 2015 | 41 | 0 |
| 2016 | 35 | 0 |
| 2017 | 40 | 0 |
| 2018 | 39 | 0 |
| 2019 | 27 | 0 |
| 2020 | 36 | 0 |
| 2021 | 31 | 1 |
| 2022 | 40 | 0 |
| 2023 | 59 | 0 |
| 2024 | 59 | 0 |
| 2025 | 50 | 0 |
| 2026 | 48 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | other ISOLA Components Named without a submission number |
What descends from it? (587)
See all 5875 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K071668 (Paradigm Spine, 2008) has gone furthest, with 582 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When labeled for pedicle screw fixation, the ISOLA implants are intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral (L5-S1) joint utilizing autologous bone graft and intended to be removed after solid fusion is attained. The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are…
Read the full statement (120 words)
When labeled for pedicle screw fixation, the ISOLA implants are intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral (L5-S1) joint utilizing autologous bone graft and intended to be removed after solid fusion is attained.
The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are 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/K962984 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962984: Isola Pediatric Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962984
Report an extraction error
Are you the manufacturer?
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