510(k) · Cleared
ClearedModification to Isola Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Dec 29, 1999 after a 113-day review. The FDA summary names no predicate by number. 1 of the 585 devices in its family, counting itself, has a Class I recall. 584 later devices descend from it.
- Decided
- Dec 29, 1999
- Review
- 113 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
584 later devices descend from it, 3 citing it directly. 1 of the 585 devices in this family, counting this one, has a Class I recall.
- This deviceK993030 Modification to Isola Spinal SystemDepuyacromed · 1999
- Descendant · cites it directly · 581 of its ownK021335 Monarch Spine SystemDepuyacromed · 2002
- Descendant · 2 generations on · 578 of its ownK024348 Monarch Spine SystemDepuyacromed · 2003
- Descendant · 3 generations on · 495 of its ownK052131 Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005
- Descendant · 4 generations on · 490 of its ownK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- Descendant · 5 generations on · 424 of its ownK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
Showing 5 of 584 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 584 · See all- K021335Monarch Spine SystemDepuyacromed · 2002 · cites it directly581descendants
- K024348Monarch Spine SystemDepuyacromed · 2003 · 2 generations on578descendants
- K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc. · 2005 · 3 generations on495descendants
- K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 4 generations on490descendants
- K063156Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 5 generations on424descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993030 | Modification to Isola Spinal System | Depuyacromed | 1999 | — |
| +1 | K021335 | Monarch Spine System | Depuyacromed | 2002 | — |
| +2 | K024348 | Monarch Spine System | Depuyacromed | 2003 | — |
| +3 | K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods | Depuy Spine, Inc. | 2005 | — |
| +4 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| +5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 7 | 0 |
| 2012 | 21 | 0 |
| 2013 | 26 | 0 |
| 2014 | 24 | 0 |
| 2015 | 30 | 0 |
| 2016 | 23 | 0 |
| 2017 | 34 | 0 |
| 2018 | 41 | 0 |
| 2019 | 35 | 0 |
| 2020 | 37 | 0 |
| 2021 | 30 | 1 |
| 2022 | 38 | 0 |
| 2023 | 56 | 0 |
| 2024 | 54 | 0 |
| 2025 | 51 | 0 |
| 2026 | 45 | 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.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (584)
See all 5843 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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021335 (Depuyacromed, 2002) has gone furthest, with 581 descendants of its own.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, distocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and…
Read the full statement (355 words)
The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, distocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, when autogenous bone graft is used, when affixed to the posterior lumosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The Posterior ISOLA Spine 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 fusion surgery.
The Anterior ISOLA Spine System is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.
The Anterior ISOLA Spine System is 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. Specific indications include:
1. Collapsing and unstable paralytic deformity
2. Progressively increasing scoliosis.
3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or coliapse.
4. Inability to maintain sitting balance, necessitating the use of the hands.
5. Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
6. Spinal fractures (acute reduction or late deformity).
7. Degenerative Disc Disease (Defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
8. Spinal tumor.
9. Previous failed fusion surgery.
Spinal levels for Anterior ISOLA are from T5-L4.
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/K993030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993030: Modification to Isola Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993030
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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