510(k) · Cleared
ClearedModification to Parts Numbered CGT-SL and CGT-SL-15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Spine Fixation Systems, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Apr 13, 1999 as substantially equivalent to K954770 (Advanced Spine Fixation Systems, Inc., 1996) after a 29-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Apr 13, 1999
- Review
- 29 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954770 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK954770 Centra-Line Grapple, Varifix SystemAdvanced Spine Fixation Systems, Inc. · 1996
- This deviceK990845 Modification to Parts Numbered CGT-SL and CGT-SL-15Advanced Spine Fixation Systems, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954770 | Centra-Line Grapple, Varifix System | Advanced Spine Fixation Systems, Inc. | 1996 | — |
| 0 (this device) | K990845 | Modification to Parts Numbered CGT-SL and CGT-SL-15 | Advanced Spine Fixation Systems, Inc. | 1999 | — |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWP? 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 |
|---|---|---|---|
| * | K954770 | Centra-Line Grapple, Varifix SystemSummary page 1…anced Spine Fixation Systems, Inc. c/o Mr. Greg Holland Holland & Associates 3722 Avenue Saulsalito Irvine, California 92606 Re: K990845 Trade Name: Modification to K954770 - Varigrip device components numbered CGT-SL and CGT-SL-15 Regulatory Class: II Product Codes: KWP and MNH Dated: March 12, 1999… | 1996 |
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.
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 Varifix System with pedicle screw attachment is only indicated for patients with severe spondylolisthesis, grades 3 and 4, of the fifth lumbar-first sacral (L5-S1) joint. This indication is for those who are receiving fusions using autogenous bone graft only. The Varifix System is to be removed after the development of a solid fusion mass. The Varifix System with sacral screws and sublaminar wiring and the Varigrip System are intended for treatment…
Read the full statement (240 words)
The Varifix System with pedicle screw attachment is only indicated for patients with severe spondylolisthesis, grades 3 and 4, of the fifth lumbar-first sacral (L5-S1) joint. This indication is for those who are receiving fusions using autogenous bone graft only. The Varifix System is to be removed after the development of a solid fusion mass.
The Varifix System with sacral screws and sublaminar wiring and the Varigrip System are intended for treatment of cases of degenerative disc diseases (ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), sponaylolisthesis, fracture, spinal stenosis, deformities (including scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and muiti-operated back or revision of previous surgery. Other indications include degenerative lumbar scoliosis, degenerative spondylolisthesis, and in spinal stenosis, where decompression is required.
For indication other than severe spondylolisthesis (grade 3 or 4) at the L5-S1 vertebral joint this device in intended for sacral/lliac/lamina attachment only. The attachment points of the sacra! screws are intended for the S1 or S2 focations. The sublaminar wire fixation levels range from L1 to LS. To facilitate fusion of the fifth lumbar-first sacral (L5-S1) the attachment points of the pedicle screws are limited to L3, L4, and L5 vertebrae. In addition, the titanium components are also intended for those individuals who have sensitivity to some of the elements present in stainless steel alloys. The Varigrip is intended to be attached to the non-cervical spine.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990845: Modification to Parts Numbered CGT-SL and CGT-SL-15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990845
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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