510(k) · Cleared
ClearedIsola Polyaxial Washer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Nov 16, 2001 as substantially equivalent to K010576 (Depuyacromed, 2001) after a 30-day review. Its family tree reaches back 3 generations to 1995. 1 of the 271 devices in its family, counting itself, has a Class I recall. 262 later devices descend from it.
- Decided
- Nov 16, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944736 (1995). 8 ancestors in all. 262 later devices descend from it, 2 citing it directly. 1 of the 271 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
- 2 generations backK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
- 1 generation backK010576 Monarch Spine SystemDepuyacromed · 2001
- This deviceK013441 Isola Polyaxial WasherDepuyacromed · 2001
- Descendant · cites it directly · 260 of its ownK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- Descendant · 2 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · 3 generations on · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- Descendant · 4 generations on · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- Descendant · 3 generations on · 97 of its ownK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
Showing 5 of 262 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 262 · See all- K101070Expedium Spine SystemMedos International SARL · 2010 · cites it directly260descendants
- K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 2 generations on225descendants
- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 3 generations on172descendants
- K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 4 generations on158descendants
- K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013 · 3 generations on97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944736 | VSP (Variable Screw Placement) | Acromed Corp. | 1995 | — |
| −2 | K981274 | Acromed Timx Plate Based Low Back System | Acromed Corp. | 1998 | — |
| −1 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| 0 (this device) | K013441 | Isola Polyaxial Washer | Depuyacromed | 2001 | — |
| +1 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| +2 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| +3 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +4 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| +3 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 14 | 0 |
| 2019 | 15 | 0 |
| 2020 | 19 | 0 |
| 2021 | 15 | 1 |
| 2022 | 24 | 0 |
| 2023 | 35 | 0 |
| 2024 | 41 | 0 |
| 2025 | 36 | 0 |
| 2026 | 31 | 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 |
|---|---|---|---|
| * | K010576 | Monarch Spine SystemSummary page 1…isa A. Gilman August 10, 2001 Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation ISOLA Polyaxial Washer MONARCH Spine System Polyaxial Washer (K010576) The ISOLA Polyaxial Washer construct will allow the current monoaxial screws of the ISOLA Spinal System to exhibit properties s… | 2001 |
What descends from it? (262)
See all 2622 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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K101070 (Medos International SARL, 2010) has gone furthest, with 260 descendants of its own.
- 10 other devices also cite its predicate K010576.
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?
The ISOLA Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed…
Read the full statement (222 words)
The ISOLA Spinal System is a pedicle screw system intended to provide
immobilization and stabilization of spinal segments in skeletally mature patients
as an adjunct to fusion in the treatment of the following acute and chronic
instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative
spondylolisthesis with objective evidence of neurological impairment, fracture,
dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion
(pseudarthrosis).
The ISOLA Spinal System is also indicated for pedicle screw fixation for the
treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in
skeletally mature patients receiving fusion by autogenous bone graft having
implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of
the implants after the attainment of a solid fusion.
The ISOLA Spinal System is also a hook and sacralfiliac screw fixation system of
the noncervical spine indicated for degenerative disc disease (defined as discogenic
back pain with degeneration of the disc confirmed by history and radiographic
studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis,
deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion
(pseudarthrosis).
The 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). Levels of fixation are for the
thoracic, lumbar and sacral spine.
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/K013441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013441: Isola Polyaxial Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013441
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026