510(k) · Cleared
ClearedSynthes Spine Anterior Thoracolumbar Rod Clamp (Atrc) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 2, 1998 as substantially equivalent to K925351 (Synthes (Usa), 1993) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Mar 2, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922855 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK922855 Synthes Universal Spine Rod and Screw Fixation SysSynthes (Usa) · 1993
- This deviceK974525 Synthes Spine Anterior Thoracolumbar Rod Clamp (Atrc) SystemSynthes Spine · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922855 | Synthes Universal Spine Rod and Screw Fixation Sys | Synthes (Usa) | 1993 | — |
| 0 (this device) | K974525 | Synthes Spine Anterior Thoracolumbar Rod Clamp (Atrc) System | Synthes Spine | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 KWQ? 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? (2)
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 |
|---|---|---|---|
| * | K925351 | Synthes (U.S.a.) Anterior Spinal PlateSummary page 1…em compared t0 the Synthes Spine Antenior fhoracolumbar Locking Plare Sysiem (ATLP) uud the Synthes Spine Universal Spinal Rod wud Screw Fixation System (USS) cleared in K925351 and K922855, respectively. The Syathes Spine Anterior Thoracalumbar Rod Clamp (A'1RC) System consists of a rod, a choice of tare… | 1993 |
| * | K922855 | Synthes Universal Spine Rod and Screw Fixation SysSummary page 1…t0 the Synthes Spine Antenior fhoracolumbar Locking Plare Sysiem (ATLP) uud the Synthes Spine Universal Spinal Rod wud Screw Fixation System (USS) cleared in K925351 and K922855, respectively. The Syathes Spine Anterior Thoracalumbar Rod Clamp (A'1RC) System consists of a rod, a choice of taree clamps, on… | 1993 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K925351.
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 Synthes Spine Anterior Thoracolumbar Rod Clamp (ATRC) System consists of a rod, a choice of three clamps, one bone screw and one set screw. It is intended for use in stabilizing bone graft following anterior decompression of burst fractures. vertebrectomy and vertebral body replacement in tumor patients. anterior fusion following failed posterior lumbar surgery. anterior fusion following severe disc degeneration. Degenerative Disc Disease is defined…
Read the full statement (116 words)
The Synthes Spine Anterior Thoracolumbar Rod Clamp (ATRC) System consists of a rod, a choice of three clamps, one bone screw and one set screw. It is intended for use in stabilizing
bone graft following anterior decompression of burst fractures.
vertebrectomy and vertebral body replacement in tumor patients.
anterior fusion following failed posterior lumbar surgery.
anterior fusion following severe disc degeneration. Degenerative Disc Disease is defined as back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies
correction of anterolateral lordotic deformities for the spine, lumbar scoliosis and pseudoarthrosis of the thoracolumbar spine.
This system is intended for anterolateral intervertebral body screw fixation/attachment to the T8 - L5 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/K974525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974525: Synthes Spine Anterior Thoracolumbar Rod Clamp (Atrc) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974525
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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