510(k) · Cleared
ClearedViceroy Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Torrey Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Nov 20, 2012 as substantially equivalent to K071824 (Acme Spine, LLC, 2007) and 2 other predicates after a 117-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Nov 20, 2012
- Review
- 117 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K955348 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −1 | K103490 | Expedium Spine System, Moss Miami Spine System | Johnson & Johnson | 2011 | — |
| 0 (this device) | K122229 | Viceroy Spinal System | Torrey Spine | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K071824 | Acme Talon Pedicle ScrewSummary page 1…thopedic and Rehabilitation Devices Panel Predicate Devices: Device Names: ACME Spinal System, 5 10(K) Number: K071824 Moss Miami and Expedium Spinal System, 5 10(K) Number:… | 2007 |
| * | K103490 | Expedium Spine System, Moss Miami Spine SystemSummary page 1…inal System, 5 10(K) Number: K071824 Moss Miami and Expedium Spinal System, 5 10(K) Number: K103490& K955348 SUBSTANTIAL EQIJIVILENCE The VICEROY Spine System is substantially equivalent to the ACME Spinal System (K071824), DeP… | 2011 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 1…em, 5 10(K) Number: K071824 Moss Miami and Expedium Spinal System, 5 10(K) Number: K103490& K955348 SUBSTANTIAL EQIJIVILENCE The VICEROY Spine System is substantially equivalent to the ACME Spinal System (K071824), DePuy Moss M… | 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
- None of the 4 ancestors has a recall.
- 5 other devices also cite its predicate K071824.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the VICEROY Spine System is 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: (1) degenerative disc disease (defined as back pain of…
Read the full statement (122 words)
When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the VICEROY Spine System is 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, kyphosis, and/or lordosis, (7) tumor, (8) failed previous fusion (i.e. pseudartlirosis).,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122229: Viceroy Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122229
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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