510(k) · Cleared
ClearedModification to Opus 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 Jan 25, 2002 as substantially equivalent to K993402 (Howmedica Osteonics Corp., 1999) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it.
- Decided
- Jan 25, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K984251 (1999). 9 ancestors in all, the oldest K951725 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK984251 Xia Spine SystemHowmedica, Inc. · 1999
- 2 generations backK012027 Modification to Xia Spine SystemHowmedica Osteonics · 2001
- 1 generation backK013688 Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001
- This deviceK014229 Modification to Opus Spinal SystemHowmedica Osteonics Corp. · 2002
- Descendant · cites it directly · 0 of its ownK030369 Opus Spinal SystemHowmedica Osteonics Corp. · 2003
Most influential descendants
Showing 1 of 1 · See all- K030369Opus Spinal SystemHowmedica Osteonics Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984251 | Xia Spine System | Howmedica, Inc. | 1999 | — |
| −2 | K012027 | Modification to Xia Spine System | Howmedica Osteonics | 2001 | — |
| −1 | K013688 | Modification to Xia Spinal System | Howmedica Osteonics Corp. | 2001 | — |
| 0 (this device) | K014229 | Modification to Opus Spinal System | Howmedica Osteonics Corp. | 2002 | — |
| +1 | 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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (2)
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…21 CFR 888.3050 Pedicle Screw Spinal System 21 CFR 888.3070 Predicate Device Identification The Opusm Spinal System was determined substantially equivalent via 510(k) K993402. The Multi-Axial Cross-Connector (MAC) was determined substantially equivalent for use with the Opus Spinal System via 510(k) K0… | 1999 |
| * | K013688 | Modification to Xia Spinal SystemSummary page 1…ubstantially equivalent via 510(k) K993402. The Multi-Axial Cross-Connector (MAC) was determined substantially equivalent for use with the Opus Spinal System via 510(k) K013688. The Opusm Spinal System is made up of a range of screws, which are compatible with both the rod and plate components of the syst… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030369 | Opus Spinal System | 2003 | 0 |
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 3 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K030369 (Howmedica Osteonics Corp., 2003) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K993402.
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 Multi-Axis Cross-Connectors are intended to be used with the other components of the Opus Spinal System. When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Opus 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…
Read the full statement (131 words)
The Multi-Axis Cross-Connectors are intended to be used with the other components of the Opus Spinal System.
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Opus 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 Opus 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 using 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/K014229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014229: Modification to 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/K014229
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026