510(k) · Cleared
ClearedOsteonics Spinal System 5.5MM & 10.0MM Bone Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Sep 25, 1998 as substantially equivalent to K951725 (Osteonics Corp., 1995) after a 16-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 25, 1998
- Review
- 16 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951725 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951725 Osteonics Spinal SystemOsteonics Corp. · 1995
- This deviceK983152 Osteonics Spinal System 5.5MM & 10.0MM Bone ScrewsOsteonics Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951725 | Osteonics Spinal System | Osteonics Corp. | 1995 | — |
| 0 (this device) | K983152 | Osteonics Spinal System 5.5MM & 10.0MM Bone Screws | Osteonics Corp. | 1998 | — |
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? (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 |
|---|---|---|---|
| * | K951725 | Osteonics Spinal SystemSummary page 1…is 21 CFR §888.3050 Predicate Device Identification The Osteonics® Spinal System, which includes bone screws, was determined to be substantially equivalent via 510(k) #K951725. The proposed 5.5mm and 10.0mm bone screws of the Osteonics® Spinal System are substantially equivalent to those bone screws in t… | 1995 |
| * | — | Danek TSRH Spinal System Named without a submission number | |
| * | — | AcroMed Titanium Bone Screws 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?
- Its one ancestor has no recall.
- 15 other devices also cite its predicate K951725.
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?
The uses for the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws, as part of the legally marketed Osteonics® Spinal System, are as follows: Non-Pedicular Use; fixation of the T4-S2 spine: Long and short curve scoliosis Vetebral fracture or dislocation Spondylolisthesis Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Previously failed fusion Spinal tumor…
Read the full statement (146 words)
The uses for the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws, as part of the legally marketed Osteonics® Spinal System, are as follows:
Non-Pedicular Use; fixation of the T4-S2 spine:
Long and short curve scoliosis
Vetebral fracture or dislocation
Spondylolisthesis
Degenerative disc disease (defined as back pain of discogenic origin with degeneration of
the disc confirmed by history and radiographic studies).
Previously failed fusion
Spinal tumor
Pedicular Use:
When used as a pedicle screw system, the system is intended for patients: (a) having severe
spondylolisthesis (Grades 3 and 4) at the L5-S1 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. Pedicle screws are not intended for placement in pedicles above L3.
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/K983152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983152: Osteonics Spinal System 5.5MM & 10.0MM Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983152
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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