510(k) · Cleared
ClearedOsteonics Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Feb 14, 2002 as substantially equivalent to K990158 (Osteonics Corp., 1999) and 2 other predicates after a 17-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Feb 14, 2002
- Review
- 17 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K951725 (1995). 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 | K951725 | Osteonics Spinal System | Osteonics Corp. | 1995 | — |
| −1 | K990158 | Osteonics Combination Screw Ring/Blocker | Osteonics Corp. | 1999 | — |
| 0 (this device) | K020293 | Osteonics Spinal System | Howmedica Osteonics Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 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? (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 |
|---|---|---|---|
| * | K990158 | Osteonics Combination Screw Ring/BlockerSummary page 1…ce are substantially equivalent to features of the Osteonics® Spinal System (OSS) Combination Screw Ring/Blocker which was determined substantially equivalent via 510(k) K990158 and to the OSS Screw Blocker and Cap which were determined substantially equivalent via 510(k) K951725. The modified device shall… | 1999 |
| * | K951725 | Osteonics Spinal SystemSummary page 1…g/Blocker which was determined substantially equivalent via 510(k) K990158 and to the OSS Screw Blocker and Cap which were determined substantially equivalent via 510(k) K951725. The modified device shall be referred to here in as the Diapson Combo. The Xia 6 mm diameter rods were determined substantially… | 1995 |
| * | K984251 | Xia Spine SystemSummary page 1…alent via 510(k) K951725. The modified device shall be referred to here in as the Diapson Combo. The Xia 6 mm diameter rods were determined substantially equivalent via K984251. Description of Device Modification " The design change involves modifying the ring height, blocker height and assembly process… | 1999 |
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 7 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
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 subject component, a design modification to the Osteonics® Spinal System Combination Screw Ring/Blocker, is a single-use device which is sold non-sterile and is intended for use only with the other components of the commercially available Osteonics® Spinal System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System. The uses for the legally marketed Osteonics® Spinal System are as follows…
Read the full statement (240 words)
The subject component, a design modification to the Osteonics® Spinal System Combination Screw Ring/Blocker, is a single-use device which is sold non-sterile and is intended for use only with the other components of the commercially available Osteonics® Spinal System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System.
The uses for the legally marketed Osteonics® Spinal System are as follows:
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:
Long and short curve scoliosis
Vertebral 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 fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics® Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, the Osteonics® Spinal system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
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/K020293 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020293: Osteonics Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020293
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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