510(k) · Cleared
ClearedSSCS (Segmental Spinal Correction System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteotech, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jul 23, 1999 after a 77-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 23, 1999
- Review
- 77 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 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? (3)
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 |
|---|---|---|---|
| * | — | SSCS Named without a submission number | |
| * | — | ISOLA Named without a submission number | |
| * | — | TSRH 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.
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 SSCS is intended for use as a posterior spinal fixation device, with specific indications as follows: 1) When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for: scoliosis; kyphosis; spinal fractures; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
Read the full statement (203 words)
The SSCS is intended for use as a posterior spinal fixation device, with specific indications as follows:
1) When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for: scoliosis; kyphosis; spinal fractures; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); tumors; stenosis; spondylolisthesis; pseudoarthrosis; and previously failed attempts at spinal fusion.
2) When used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine, the SSCS is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
3) In addition, when used as a pedicle screw system, the SSCS is intended for patients:
a. Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint
b. Who are receiving fusions using autogenous bone graft only.
c. Who are having the device fixed or attached to the lumbar and sacral spine (level of attachment: L3 and below).
d. Who are having the device removed after the development of a solid fusion mass.
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/K991586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991586: SSCS (Segmental Spinal Correction System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991586
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026