510(k) · Cleared
ClearedSCS Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthotec, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Dec 18, 1998 as substantially equivalent to K974749 (Cross Medical Products, Inc., 1998) and 2 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.
- Decided
- Dec 18, 1998
- Review
- 86 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K901587 (1990). 15 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 3 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 2 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 1 generation backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- This deviceK983353 SCS Spinal SystemOrthotec, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK994288 5.0MM Spinal ScrewsOrtho Tec, LLC · 2000
- Descendant · cites it directly · 0 of its ownK993926 Omniaxial ConnectorOrtho Tec, LLC · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −3 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −2 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −1 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| 0 (this device) | K983353 | SCS Spinal System | Orthotec, Inc. | 1998 | — |
| +1 | K994288 | 5.0MM Spinal Screws | Ortho Tec, LLC | 2000 | — |
| +1 | K993926 | Omniaxial Connector | Ortho Tec, LLC | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 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.
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 |
|---|---|---|---|
| * | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Summary page 3…5 of 11 kqa¥33%3 3stS From: Dr. Patrick Bertranou @YTo: Paul Williams FDA Date: 12/18/1998 T'me: 1£:28:56 AM 4, Equivalent Predicate Device: Synergy™ Spinal System: K974749, K950709 & K950099 — Cross Medical Products, Inc. The Synergy™ Spinal System is cleared for marketing as a system described in a… | 1998 |
| * | K950709 | Synergy TI Anterior Spinal SystemSummary page 3…kqa¥33%3 3stS From: Dr. Patrick Bertranou @YTo: Paul Williams FDA Date: 12/18/1998 T'me: 1£:28:56 AM 4, Equivalent Predicate Device: Synergy™ Spinal System: K974749, K950709 & K950099 — Cross Medical Products, Inc. The Synergy™ Spinal System is cleared for marketing as a system described in all of the… | 1995 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 3…3stS From: Dr. Patrick Bertranou @YTo: Paul Williams FDA Date: 12/18/1998 T'me: 1£:28:56 AM 4, Equivalent Predicate Device: Synergy™ Spinal System: K974749, K950709 & K950099 — Cross Medical Products, Inc. The Synergy™ Spinal System is cleared for marketing as a system described in all of the following… | 1997 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K994288 (Ortho Tec, LLC, 2000) has gone furthest, with 0 descendants of its own.
- 19 other devices also cite its predicate K974749.
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 used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosis) The system is indicated for thoracic, lumbar and sacral level. When…
Read the full statement (248 words)
When used as a nonpedicle posterior system, the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
spondylolisthesis
fracture
spinal stenosis
deformities (i.e., scoliosis, kyphosis, lordosis)
tumors
pseudarthrosis
failed previous fusion (pseudarthrosis)
The system is indicated for thoracic, lumbar and sacral level.
When used as an anterolateral/anterior system the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
spondylolisthesis
fracture
spinal stenosis
deformities (i.e., scoliosis, kyphosis, lordosis)
tumors
pseudarthrosis
failed previous fusion (pseudarthrosis)
The system is indicated for thoracic and lumbar level.
When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients who are:
having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint
receiving fusions using autogenous bone graft only
having the device fixed or attached to the lumbar and sacral spine
having the device removed after the development of a solid fusion mass.
Screw fixation is limited to L3 and below.
Posterior pedicle systems are 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 neurologic impairment
fracture
dislocation
scoliosis
kyphosis
spinal tumor
failed previous fusion (pseudarthrosis)
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/K983353 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983353: SCS Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983353
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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