510(k) · Cleared
ClearedOpus Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 8, 2003 as substantially equivalent to K993402 (Howmedica Osteonics Corp., 1999) and 2 other predicates after a 185-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Aug 8, 2003
- Review
- 185 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K984251 (1999). 11 ancestors in all, the oldest K951725 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK984251 Xia Spine SystemHowmedica, Inc. · 1999
- 3 generations backK012027 Modification to Xia Spine SystemHowmedica Osteonics · 2001
- 2 generations backK013688 Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001
- 1 generation backK014229 Modification to Opus Spinal SystemHowmedica Osteonics Corp. · 2002
- This deviceK030369 Opus Spinal SystemHowmedica Osteonics Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K984251 | Xia Spine System | Howmedica, Inc. | 1999 | — |
| −3 | K012027 | Modification to Xia Spine System | Howmedica Osteonics | 2001 | — |
| −2 | K013688 | Modification to Xia Spinal System | Howmedica Osteonics Corp. | 2001 | — |
| −1 | K014229 | Modification to Opus Spinal System | Howmedica Osteonics Corp. | 2002 | — |
| 0 (this device) | K030369 | Opus Spinal System | Howmedica Osteonics Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K993402 | Opus Spinal SystemSummary page 1…/Diapason and Xia@Titanium Hooks with the ~pusrMSpinal System. Predicate Device Information: The Opu? Spinal System was determined substantially equivalent via 5 10(k)s K993402 and KO 14229. The Multi-Axial Cross-Connector (MAC) was determined substantially equivalent for use with the Opusm Spinal System… | 1999 |
| * | K014229 | Modification to Opus Spinal System | 2002 |
| * | K003490 | Opus Rod Fixation SystemSummary page 1…ivalent via 5 10(k)s K993402 and KO 14229. The Multi-Axial Cross-Connector (MAC) was determined substantially equivalent for use with the Opusm Spinal System via 5 10(k) K003490. The Opus'" Spinal System is made up of a range of screws, which are compatible with both the rod and plate components of the sys… | 2000 |
| * | — | OSS/Diapason Spinal System titanium hooks Named without a submission number | |
| * | — | Xia Spinal System titanium hooks 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.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K993402.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Opusm Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture and dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.…
Read the full statement (101 words)
The Opusm Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture and dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.
The Opusr” Spinal System is also intended to be used in conjunction with the titanium hooks from the OSS/Diapason Spinal System and the Xia Spinal System. The Opusm Spinal System is also intended to be used in conjunction with the Multi-Axis Cross Connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030369: Opus 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/K030369
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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