510(k) · Cleared
ClearedUltium Spinal Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc., Orthopaedic Div. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Oct 2, 1996 after a 77-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Oct 2, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK962784 Ultium Spinal Plating SystemSmith & Nephew, Inc., Orthopaedic Div. · 1996
- Descendant · cites it directly · 0 of its ownK160982 Sphynx™Eden Spine, LLC · 2016
- Descendant · cites it directly · 0 of its ownK053070 Contour II Spinal SystemAltiva Corp. · 2006
- Descendant · cites it directly · 0 of its ownK051044 Arctec Semirigid Plating SystemAltiva Corp. · 2005
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962784 | Ultium Spinal Plating System | Smith & Nephew, Inc., Orthopaedic Div. | 1996 | — |
| +1 | K160982 | Sphynx™ | Eden Spine, LLC | 2016 | — |
| +1 | K053070 | Contour II Spinal System | Altiva Corp. | 2006 | — |
| +1 | K051044 | Arctec Semirigid Plating System | Altiva Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2016 | 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 MNH? 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? (4)
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 |
|---|---|---|---|
| * | — | Simmons Plating System Named without a submission number | |
| * | — | Rogozinski Spinal Rod System Named without a submission number | |
| * | — | Steffee Plating System (VSP) Named without a submission number | |
| * | — | Dynalok System Named without a submission number |
What descends from it? (3)
3 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?
- Of its descendants, K160982 (Eden Spine, LLC, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Posterior Fixation / Attachment (Pedicle fixation): The Ultium Spinal Plating System bolts when placed in the pedicles are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 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; and (d) who are having the device removed after…
Read the full statement (174 words)
Posterior Fixation / Attachment (Pedicle fixation): The Ultium Spinal Plating System bolts when placed in the pedicles are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 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; and (d) who are having the device removed after the development of a solid fusion mass. When used as a pedicle screw system, the bolts may be used for the indications specified previously to affix the plates to vertebral levels L3 to S1 inclusive.
Anterior Fixation / Attachment (anterolateral intervertebral bodies). The Ultium Spinal Plating System when attached anterolaterally to the vertebral bodies of levels T10 to S1, inclusive, is intended for the treatment of: degenerative disc disease (defined as back pain of discogenic orgin with degeneration of the disk confirmed by historical and radiographic studies); pseudarthrosis, stenosis, scoliosis, spondylolisthesis; unsuccessful previous attempts at spinal fusion; or tumor resection.
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/K962784 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962784: Ultium Spinal Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962784
Report an extraction error
Are you the manufacturer?
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